Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, NVA237, glycopyrronium bromide
Brief summary
This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic obstructive pulmonary disease.
Interventions
Glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Placebo to glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Tiotropium was supplied in powder-filled capsules together with the Handihaler® device.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Male or female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure. 2. Patients with moderate to severe stable chronic obstructive pulmonary disease (COPD, Stage II or Stage III) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008. 3. Current or ex-smokers who have a smoking history of at least 10 pack years. 4. Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30% and \< 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity (FVC) \< 0.7 at Visit 2 (Day -14). 5. Patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3 (Day 1).
Exclusion criteria
1. Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test). 2. Women of child-bearing potential, unless using an approved method of medical or surgical contraception. 3. Patients requiring long term oxygen therapy (\> 15 h a day) on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 (Day -21) or between Visit 1 (Day -21) and Visit 3 (Day 1). 4. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1 (Day -21). 5. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition. 6. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \> 600/mm\^3 (at Visit 1, Day -21) and onset of symptoms prior to age 40 years. 7. Patients with a history of long QT syndrome or whose QTc measured at Visit 1 (Day -21) (Fridericia method) is prolonged (\> 450 ms for males or \> 470 ms for females. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Week 12 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included baseline FEV1 measurement, baseline inhaled corticosteroid use (Yes/No), FEV1 prior to inhalation of short-acting β2 agonist (SABA), and FEV1 45 min post-inhalation of SABA as covariates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life (QoL) Assessed With the St. George Respiratory Questionnaire (SGRQ) at Week 52 | Week 52 | The SGRQ contained 51 patient-rated items divided into three components: Symptoms (respiratory symptoms, their frequency, and severity), Activity (activities that cause or are limited by breathlessness), and Impacts (social functioning and psychological disturbances resulting from airway disease). A total score for the 3 components was calculated and ranged from 0 to 100. Higher values indicate greater impairment of QoL. The analysis included the same covariates as the primary Outcome Measure. |
| Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52) | Baseline to Week 52 (patients with no moderate or severe exacerbations who completed the study were censored at the final visit date, which may have exceeded 52 weeks) | Time to first moderate or severe COPD exacerbation was calculated as the number of days from baseline to the day on which the patient experienced the first moderate or severe COPD exacerbation. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required. |
| Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Taken During the Study (Baseline to Week 52) | Baseline to Week 52 | The number of puffs of rescue medication taken in the previous 12 hours was recorded in the Patient Diary in the morning and evening. The mean daily number of puffs of rescue medication taken was calculated by dividing the number of puffs of rescue medication per day over the 52 weeks of the study by the number of days with non-missing rescue medication data. Rescue medication data recorded during the 14 day run-in period was used to calculate the baseline. The analysis included the same covariates as the primary Outcome Measure. A positive change score indicates more puffs taken. |
| Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52 | Day 1, Week 26, and Week 52 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included the same covariates as the primary Outcome Measure. |
| Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52 | Day 1, Week 12, Week 26, and Week 52 | Trough FVC is defined as the average of the post-dose 23 h 15 min and the 23 h 45 min FVC values. Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told At the end of the next normal breath out, take a deep breath all the way in; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. |
| Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | 5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks. |
| Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | 5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told At the end of the next normal breath out, take a deep breath all the way in; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks. |
| Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | 5, 15, and 30 minutes; and 1, 2, 3, 4 hours post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks. |
| Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | 5, 15, and 30 minutes; and 1, 2, 3, 4 hours post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told At the end of the next normal breath out, take a deep breath all the way in; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks. |
| Transition Dyspnea Index (TDI) at Week 26 | Week 26 | The TDI measured changes in dyspnea from baseline during treatment and included 3 domains: Functional impairment (activities of daily living), magnitude of task (intensity of activity), and magnitude of effort (difficulty breathing). Each domain was rated from -3 to 3 (major deterioration-major improvement). The total score ranged from -9 to 9; minus scores indicate deterioration. The analysis included the same covariates as the primary Outcome Measure. |
| Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52 | From 5 minutes to 12 hours post-dose at Day 1 and Weeks 12 and 52 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, 4, 6, 8 10, and 12 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure. |
| Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes and From 12 Hours to 23 Hours 45 Minutes Post-dose at Weeks 12 and 52 | From 5 minutes to 23 hours 45 minutes post-dose at Weeks 12 and 52 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure. |
| Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Per Year During the Study (Baseline to Week 52) | Baseline to Week 52 | The number of moderate or severe exacerbations of COPD per year during the study was calculated by dividing the total number of exacerbations during the study by the total number of years of treatment. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required. |
| Percentage of Patients Who Experienced a Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52) | Baseline to Week 52 | A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required. |
| Percentage of Nights With no Nighttime Awakenings During the Study (Baseline to Week 52) | Baseline to Week 52 | A night with no nighttime awakenings was defined as any night where the patient did not wake up due to 1 or more of 6 symptoms (respiratory symptoms, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Symptoms occurring during the previous 12 hours were recorded each morning and evening by the patient in an electronic diary. The percentage of nights with 'no nighttime awakenings' was calculated as the total number of nights with no nighttime awakenings over the 52 week treatment period divided by the total number of nights where diary recordings were made. |
| Percentage of Days With no Daytime Symptoms During the Study (Baseline to Week 52) | Baseline to Week 52 | A day with no daytime symptoms was defined as any day where the patient recorded no cough, no wheeze, no production of sputum, no feeling of breathlessness (other than when running), and no puffs of rescue medication during the previous 12 hours in evening entry in the electronic patient diary. The percentage of days with no daytime symptoms was calculated as the total number of days with no daytime symptoms over the 52 week treatment period divided by the total number of days where diary recordings were made. |
| Percentage of Days Able to Perform Usual Daily Activities During the Study (Baseline to Week 52) | Baseline to Week 52 | A day able to perform usual daily activities was defined as any day where the patient recorded in their electronic diary in the evening that they were not prevented from performing their usual daily activities due to respiratory symptoms during the previous 12 hours. The percentage of days able to perform usual daily activities was calculated as the total number of days able to perform usual daily activities over the 52 week treatment period divided by the total number of days where diary recordings were made. |
| Change From Baseline in the Mean Daily Total Symptom Score During the Study (Baseline to Week 52) | Baseline to Week 52 | The daily total symptom score was defined as the sum of the morning and evening patient self-reported diary assessments of 6 symptoms (respiratory symptoms/impact on daily activities, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Means for baseline (14 day maximum run-in period) and the 52 week treatment period were calculated. Mean scores ranged from 0-18, with a higher score indicating worse symptoms. A negative change score indicated improvement. |
| Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52 | From 5 minutes to 4 hours post-dose at Day 1 and Weeks 12, 26, and 52 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, and 4 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure. |
Countries
Argentina, Canada, Chile, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, New Zealand, Peru, Poland, Russia, South Korea, United States
Participant flow
Recruitment details
A total of 1993 patients were screened from 180 participating sites, of whom 1066 were randomized to 1 of the 3 treatment groups in a 2:1:1 ratio glycopyrronium bromide:placebo:tiotropium.
Participants by arm
| Arm | Count |
|---|---|
| Glycopyrronium Bromide 50 μg Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | 525 |
| Placebo to Glycopyrronium Bromide Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | 268 |
| Tiotropium 18 μg Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | 267 |
| Total | 1,060 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Abnormal laboratory value(s) | 0 | 1 | 0 |
| Overall Study | Abnormal test procedure result(s) | 0 | 1 | 1 |
| Overall Study | Administrative problems | 4 | 1 | 2 |
| Overall Study | Adverse Event | 40 | 29 | 18 |
| Overall Study | Death | 2 | 2 | 2 |
| Overall Study | Lost to Follow-up | 7 | 7 | 3 |
| Overall Study | Patient inability to use the device | 0 | 1 | 0 |
| Overall Study | Protocol deviation | 5 | 2 | 4 |
| Overall Study | Subject withdrew consent | 40 | 23 | 26 |
| Overall Study | Unsatisfactory therapeutic effect | 20 | 9 | 6 |
Baseline characteristics
| Characteristic | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg | Total |
|---|---|---|---|---|
| Age Continuous | 63.5 years STANDARD_DEVIATION 9.05 | 63.6 years STANDARD_DEVIATION 9.14 | 63.9 years STANDARD_DEVIATION 8.25 | 63.6 years STANDARD_DEVIATION 8.87 |
| Sex: Female, Male Female | 186 Participants | 95 Participants | 99 Participants | 380 Participants |
| Sex: Female, Male Male | 339 Participants | 173 Participants | 168 Participants | 680 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 305 / 525 | 164 / 268 | 156 / 267 |
| serious Total, serious adverse events | 65 / 525 | 43 / 268 | 40 / 267 |
Outcome results
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included baseline FEV1 measurement, baseline inhaled corticosteroid use (Yes/No), FEV1 prior to inhalation of short-acting β2 agonist (SABA), and FEV1 45 min post-inhalation of SABA as covariates.
Time frame: Week 12
Population: Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | 1.469 Liters | Standard Error 0.0141 |
| Placebo to Glycopyrronium Bromide | Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | 1.372 Liters | Standard Error 0.0173 |
| Tiotropium 18 μg | Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | 1.455 Liters | Standard Error 0.017 |
Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Taken During the Study (Baseline to Week 52)
The number of puffs of rescue medication taken in the previous 12 hours was recorded in the Patient Diary in the morning and evening. The mean daily number of puffs of rescue medication taken was calculated by dividing the number of puffs of rescue medication per day over the 52 weeks of the study by the number of days with non-missing rescue medication data. Rescue medication data recorded during the 14 day run-in period was used to calculate the baseline. The analysis included the same covariates as the primary Outcome Measure. A positive change score indicates more puffs taken.
Time frame: Baseline to Week 52
Population: Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Taken During the Study (Baseline to Week 52) | -1.58 Puffs | Standard Error 0.151 |
| Placebo to Glycopyrronium Bromide | Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Taken During the Study (Baseline to Week 52) | -1.20 Puffs | Standard Error 0.184 |
| Tiotropium 18 μg | Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Taken During the Study (Baseline to Week 52) | -1.83 Puffs | Standard Error 0.183 |
Change From Baseline in the Mean Daily Total Symptom Score During the Study (Baseline to Week 52)
The daily total symptom score was defined as the sum of the morning and evening patient self-reported diary assessments of 6 symptoms (respiratory symptoms/impact on daily activities, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Means for baseline (14 day maximum run-in period) and the 52 week treatment period were calculated. Mean scores ranged from 0-18, with a higher score indicating worse symptoms. A negative change score indicated improvement.
Time frame: Baseline to Week 52
Population: Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Change From Baseline in the Mean Daily Total Symptom Score During the Study (Baseline to Week 52) | -1.85 Units on a scale | Standard Error 0.125 |
| Placebo to Glycopyrronium Bromide | Change From Baseline in the Mean Daily Total Symptom Score During the Study (Baseline to Week 52) | -1.42 Units on a scale | Standard Error 0.149 |
| Tiotropium 18 μg | Change From Baseline in the Mean Daily Total Symptom Score During the Study (Baseline to Week 52) | -1.87 Units on a scale | Standard Error 0.149 |
Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52
FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.
Time frame: 5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52
Population: Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 12 (n=130, 69, 70) | 1.522 Liters | Standard Error 0.0254 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 30 (n=123, 61, 58) | 1.537 Liters | Standard Error 0.0332 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 4 (n=124, 64, 68) | 1.584 Liters | Standard Error 0.0319 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 2 (n=144, 75, 75) | 1.639 Liters | Standard Error 0.0202 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 15 (n=123, 61, 58) | 1.520 Liters | Standard Error 0.0305 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 6 (n=123, 63, 69) | 1.558 Liters | Standard Error 0.0321 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 15 (n=126, 66, 67) | 1.518 Liters | Standard Error 0.0269 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 8 (n=121, 64, 69) | 1.535 Liters | Standard Error 0.031 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 5 (n=119, 61, 58) | 1.512 Liters | Standard Error 0.0305 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 10 (n=124, 61, 69) | 1.541 Liters | Standard Error 0.0296 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 15 (n=129, 71, 72) | 1.471 Liters | Standard Error 0.0214 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, hour 1 (n=125, 62, 63) | 1.557 Liters | Standard Error 0.0285 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 12 (n=122, 58, 68) | 1.522 Liters | Standard Error 0.0313 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 30 (n=125, 62, 62) | 1.567 Liters | Standard Error 0.0302 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 15 (n=123, 62, 63) | 1.529 Liters | Standard Error 0.03 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 22 (n=117, 60, 63) | 1.420 Liters | Standard Error 0.0268 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 16 (n=117, 53, 46) | 1.377 Liters | Standard Error 0.0309 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 5 (n=125, 62, 63) | 1.515 Liters | Standard Error 0.0293 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 16 (n=109, 56, 57) | 1.431 Liters | Standard Error 0.032 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 45 (n=117, 56, 61) | 1.483 Liters | Standard Error 0.0296 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 45 (n=124, 65, 63) | 1.513 Liters | Standard Error 0.0294 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 45 (n=128, 74, 75) | 1.518 Liters | Standard Error 0.021 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 15 (n=120, 55, 61) | 1.477 Liters | Standard Error 0.0323 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 5 (n=123, 65, 64) | 1.538 Liters | Standard Error 0.0296 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 15 (n=124, 65, 65) | 1.557 Liters | Standard Error 0.0309 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, 15 minutes (n=121, 62, 57) | 1.447 Liters | Standard Error 0.0287 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 4 (n=124, 64, 62) | 1.577 Liters | Standard Error 0.0304 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 30 (n=125, 65, 65) | 1.570 Liters | Standard Error 0.0303 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 15 (n=129, 67, 66) | 1.523 Liters | Standard Error 0.0251 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 3 (n=124, 64, 64) | 1.614 Liters | Standard Error 0.0303 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 5 (n=125, 66, 63) | 1.518 Liters | Standard Error 0.0281 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 5 (n=135, 65, 73) | 1.494 Liters | Standard Error 0.0246 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 2 (n=124, 64, 63) | 1.590 Liters | Standard Error 0.0317 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 15 (n=124, 65, 63) | 1.535 Liters | Standard Error 0.0285 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 1 (n=127, 64, 64) | 1.546 Liters | Standard Error 0.0275 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 30 (n=125, 65, 63) | 1.576 Liters | Standard Error 0.0277 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 3 (n=143, 74, 73) | 1.629 Liters | Standard Error 0.0199 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 30 (n=125, 64, 64) | 1.529 Liters | Standard Error 0.0285 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 5 (n=123, 62, 64) | 1.483 Liters | Standard Error 0.0278 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 15 (n=139, 75, 74) | 1.548 Liters | Standard Error 0.0152 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 15 (n=121, 61, 61) | 1.521 Liters | Standard Error 0.028 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 15 (n=136, 67, 70) | 1.575 Liters | Standard Error 0.0239 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 10 (n=119, 59, 55) | 1.478 Liters | Standard Error 0.0304 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 30 (n= 139, 70, 74) | 1.551 Liters | Standard Error 0.0236 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, hour 1 (n=140, 68, 74) | 1.575 Liters | Standard Error 0.0242 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 4 (n=144, 70, 74) | 1.599 Liters | Standard Error 0.0221 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 15 (n=133, 70, 72) | 1.530 Liters | Standard Error 0.0246 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 5 (n=134, 66, 68) | 1.550 Liters | Standard Error 0.0247 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 12 (n=120, 58, 52) | 1.451 Liters | Standard Error 0.0334 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 4 (n=121, 60, 55) | 1.535 Liters | Standard Error 0.0297 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 30 (n=143, 77, 74) | 1.561 Liters | Standard Error 0.018 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 30 (n=135, 67, 70) | 1.630 Liters | Standard Error 0.026 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 6 (n=142, 71, 74) | 1.578 Liters | Standard Error 0.0204 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 8 (n=119, 59, 54) | 1.473 Liters | Standard Error 0.03 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 5 (n=128, 66, 70) | 1.562 Liters | Standard Error 0.0268 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 1 (n=144, 76, 75) | 1.583 Liters | Standard Error 0.0172 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 6 (n=118, 59, 54) | 1.494 Liters | Standard Error 0.0294 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 15 (n=130, 66, 71) | 1.583 Liters | Standard Error 0.0267 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 15 (n=122, 59, 58) | 1.502 Liters | Standard Error 0.0282 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 3 (n=123, 62, 56) | 1.558 Liters | Standard Error 0.0263 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 30 (n=130, 67, 71) | 1.603 Liters | Standard Error 0.0265 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 8 (n=137, 70, 75) | 1.544 Liters | Standard Error 0.0226 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 2 (n=124, 61, 58) | 1.554 Liters | Standard Error 0.0295 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 5 (n=130, 69, 70) | 1.497 Liters | Standard Error 0.0254 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 22 (n=118, 60, 52) | 1.391 Liters | Standard Error 0.0302 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 5 (n=135, 74, 74) | 1.494 Liters | Standard Error 0.0135 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 5 (n=124, 60, 57) | 1.456 Liters | Standard Error 0.0276 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 1 (n=125, 62, 57) | 1.525 Liters | Standard Error 0.0271 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 30 (n=133, 69, 67) | 1.517 Liters | Standard Error 0.0275 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day1, hour 10 (n=134, 72, 75) | 1.546 Liters | Standard Error 0.0235 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 30 (n=125, 62, 58) | 1.483 Liters | Standard Error 0.028 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 1 (n=132, 67, 69) | 1.557 Liters | Standard Error 0.0273 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, 45 minutes (n=122, 61, 57) | 1.434 Liters | Standard Error 0.0281 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 30 (n=123, 60, 58) | 1.545 Liters | Standard Error 0.0287 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 2 (n=129, 65, 68) | 1.596 Liters | Standard Error 0.029 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 5 (n=120, 60, 57) | 1.490 Liters | Standard Error 0.0269 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 15 (n=123, 60, 57) | 1.529 Liters | Standard Error 0.0285 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 3 (n=126, 64, 69) | 1.600 Liters | Standard Error 0.0291 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 1 (n=125, 62, 57) | 1.356 Liters | Standard Error 0.0359 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 5 (n=135, 74, 74) | 1.416 Liters | Standard Error 0.0166 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 15 (n=139, 75, 74) | 1.428 Liters | Standard Error 0.0185 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 30 (n=143, 77, 74) | 1.409 Liters | Standard Error 0.0218 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 1 (n=144, 76, 75) | 1.404 Liters | Standard Error 0.0213 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 2 (n=144, 75, 75) | 1.445 Liters | Standard Error 0.0248 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 3 (n=143, 74, 73) | 1.435 Liters | Standard Error 0.0249 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 4 (n=144, 70, 74) | 1.415 Liters | Standard Error 0.0281 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 6 (n=142, 71, 74) | 1.426 Liters | Standard Error 0.0255 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 8 (n=137, 70, 75) | 1.431 Liters | Standard Error 0.0284 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day1, hour 10 (n=134, 72, 75) | 1.415 Liters | Standard Error 0.029 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 12 (n=130, 69, 70) | 1.369 Liters | Standard Error 0.0307 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 15 (n=129, 71, 72) | 1.396 Liters | Standard Error 0.0259 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 45 (n=128, 74, 75) | 1.446 Liters | Standard Error 0.0252 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 5 (n=135, 65, 73) | 1.421 Liters | Standard Error 0.0315 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 15 (n=133, 70, 72) | 1.411 Liters | Standard Error 0.0307 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 30 (n= 139, 70, 74) | 1.417 Liters | Standard Error 0.0297 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, hour 1 (n=140, 68, 74) | 1.409 Liters | Standard Error 0.0305 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 5 (n=134, 66, 68) | 1.448 Liters | Standard Error 0.0319 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 15 (n=136, 67, 70) | 1.452 Liters | Standard Error 0.0305 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 30 (n=135, 67, 70) | 1.481 Liters | Standard Error 0.0327 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 5 (n=128, 66, 70) | 1.417 Liters | Standard Error 0.0341 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 15 (n=130, 66, 71) | 1.441 Liters | Standard Error 0.034 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 30 (n=130, 67, 71) | 1.427 Liters | Standard Error 0.0335 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 5 (n=130, 69, 70) | 1.385 Liters | Standard Error 0.0319 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 15 (n=129, 67, 66) | 1.373 Liters | Standard Error 0.0317 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 30 (n=133, 69, 67) | 1.362 Liters | Standard Error 0.0336 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 1 (n=132, 67, 69) | 1.369 Liters | Standard Error 0.0341 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 2 (n=129, 65, 68) | 1.434 Liters | Standard Error 0.0365 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 3 (n=126, 64, 69) | 1.443 Liters | Standard Error 0.0375 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 4 (n=124, 64, 68) | 1.442 Liters | Standard Error 0.0407 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 6 (n=123, 63, 69) | 1.443 Liters | Standard Error 0.0407 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 10 (n=124, 61, 69) | 1.435 Liters | Standard Error 0.0392 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 22 (n=117, 60, 63) | 1.349 Liters | Standard Error 0.035 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 15 (n=126, 66, 67) | 1.456 Liters | Standard Error 0.0345 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 45 (n=124, 65, 63) | 1.470 Liters | Standard Error 0.0377 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 15 (n=124, 65, 65) | 1.422 Liters | Standard Error 0.038 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 30 (n=125, 65, 65) | 1.409 Liters | Standard Error 0.037 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 5 (n=125, 66, 63) | 1.393 Liters | Standard Error 0.0348 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 30 (n=125, 65, 63) | 1.391 Liters | Standard Error 0.0349 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 5 (n=123, 62, 64) | 1.361 Liters | Standard Error 0.0368 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 15 (n=121, 61, 61) | 1.377 Liters | Standard Error 0.0373 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 1 (n=127, 64, 64) | 1.364 Liters | Standard Error 0.0359 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 2 (n=124, 64, 63) | 1.422 Liters | Standard Error 0.0403 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 3 (n=124, 64, 64) | 1.442 Liters | Standard Error 0.0391 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 4 (n=124, 64, 62) | 1.416 Liters | Standard Error 0.0384 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 15 (n=120, 55, 61) | 1.374 Liters | Standard Error 0.0422 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 45 (n=117, 56, 61) | 1.401 Liters | Standard Error 0.0395 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 5 (n=125, 62, 63) | 1.359 Liters | Standard Error 0.0385 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 15 (n=123, 62, 63) | 1.360 Liters | Standard Error 0.0394 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 30 (n=125, 62, 62) | 1.353 Liters | Standard Error 0.0398 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, hour 1 (n=125, 62, 63) | 1.352 Liters | Standard Error 0.0376 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 30 (n=123, 61, 58) | 1.391 Liters | Standard Error 0.0431 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 5 (n=120, 60, 57) | 1.357 Liters | Standard Error 0.0348 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 15 (n=123, 60, 57) | 1.375 Liters | Standard Error 0.0369 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 30 (n=123, 60, 58) | 1.368 Liters | Standard Error 0.0375 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 30 (n=125, 62, 58) | 1.366 Liters | Standard Error 0.037 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 2 (n=124, 61, 58) | 1.418 Liters | Standard Error 0.0393 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 4 (n=121, 60, 55) | 1.381 Liters | Standard Error 0.0395 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 6 (n=118, 59, 54) | 1.370 Liters | Standard Error 0.0392 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 8 (n=119, 59, 54) | 1.358 Liters | Standard Error 0.0398 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 8 (n=121, 64, 69) | 1.408 Liters | Standard Error 0.0385 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 12 (n=122, 58, 68) | 1.422 Liters | Standard Error 0.0417 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 16 (n=109, 56, 57) | 1.360 Liters | Standard Error 0.0425 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 5 (n=123, 65, 64) | 1.430 Liters | Standard Error 0.0362 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 15 (n=124, 65, 63) | 1.380 Liters | Standard Error 0.0354 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 30 (n=125, 64, 64) | 1.353 Liters | Standard Error 0.0372 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 5 (n=119, 61, 58) | 1.394 Liters | Standard Error 0.0401 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 15 (n=123, 61, 58) | 1.412 Liters | Standard Error 0.0403 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 5 (n=124, 60, 57) | 1.337 Liters | Standard Error 0.0368 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 15 (n=122, 59, 58) | 1.380 Liters | Standard Error 0.0378 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 3 (n=123, 62, 56) | 1.384 Liters | Standard Error 0.0349 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 10 (n=119, 59, 55) | 1.349 Liters | Standard Error 0.0397 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, 15 minutes (n=121, 62, 57) | 1.362 Liters | Standard Error 0.0378 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, 45 minutes (n=122, 61, 57) | 1.337 Liters | Standard Error 0.0372 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 12 (n=120, 58, 52) | 1.369 Liters | Standard Error 0.0446 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 16 (n=117, 53, 46) | 1.277 Liters | Standard Error 0.0422 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 22 (n=118, 60, 52) | 1.314 Liters | Standard Error 0.0397 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 4 (n=124, 64, 68) | 1.535 Liters | Standard Error 0.0383 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 15 (n=123, 61, 58) | 1.491 Liters | Standard Error 0.0396 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 3 (n=126, 64, 69) | 1.566 Liters | Standard Error 0.0353 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, 45 minutes (n=122, 61, 57) | 1.359 Liters | Standard Error 0.0364 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 30 (n=123, 61, 58) | 1.517 Liters | Standard Error 0.0424 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 6 (n=142, 71, 74) | 1.575 Liters | Standard Error 0.0252 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 5 (n=120, 60, 57) | 1.422 Liters | Standard Error 0.0341 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 2 (n=129, 65, 68) | 1.565 Liters | Standard Error 0.0353 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 12 (n=120, 58, 52) | 1.347 Liters | Standard Error 0.0444 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 15 (n=123, 60, 57) | 1.452 Liters | Standard Error 0.0362 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 1 (n=132, 67, 69) | 1.519 Liters | Standard Error 0.0333 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 2 (n=124, 61, 58) | 1.479 Liters | Standard Error 0.0382 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 30 (n=123, 60, 58) | 1.470 Liters | Standard Error 0.0366 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 5 (n=124, 60, 57) | 1.377 Liters | Standard Error 0.0359 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 15 (n=122, 59, 58) | 1.428 Liters | Standard Error 0.0364 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 30 (n=133, 69, 67) | 1.488 Liters | Standard Error 0.0335 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 15 (n=139, 75, 74) | 1.485 Liters | Standard Error 0.0185 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 30 (n=125, 62, 58) | 1.407 Liters | Standard Error 0.0362 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 15 (n=129, 67, 66) | 1.481 Liters | Standard Error 0.0315 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 5 (n=130, 69, 70) | 1.474 Liters | Standard Error 0.0315 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 1 (n=125, 62, 57) | 1.439 Liters | Standard Error 0.0352 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 30 (n=130, 67, 71) | 1.549 Liters | Standard Error 0.0323 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 3 (n=123, 62, 56) | 1.487 Liters | Standard Error 0.0345 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 15 (n=130, 66, 71) | 1.534 Liters | Standard Error 0.0326 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 4 (n=144, 70, 74) | 1.560 Liters | Standard Error 0.0275 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 4 (n=121, 60, 55) | 1.468 Liters | Standard Error 0.039 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 5 (n=128, 66, 70) | 1.520 Liters | Standard Error 0.0326 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 6 (n=118, 59, 54) | 1.461 Liters | Standard Error 0.0388 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 30 (n=135, 67, 70) | 1.584 Liters | Standard Error 0.0317 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 8 (n=119, 59, 54) | 1.418 Liters | Standard Error 0.0394 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 10 (n=119, 59, 55) | 1.419 Liters | Standard Error 0.0391 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 15 (n=136, 67, 70) | 1.543 Liters | Standard Error 0.0295 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 5 (n=135, 65, 73) | 1.490 Liters | Standard Error 0.0299 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, hour 1 (n=140, 68, 74) | 1.540 Liters | Standard Error 0.0296 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 30 (n= 139, 70, 74) | 1.516 Liters | Standard Error 0.0289 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 5 (n=134, 66, 68) | 1.525 Liters | Standard Error 0.0305 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 15 (n=133, 70, 72) | 1.537 Liters | Standard Error 0.0303 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 45 (n=128, 74, 75) | 1.499 Liters | Standard Error 0.0249 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 6 (n=123, 63, 69) | 1.520 Liters | Standard Error 0.0381 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 3 (n=143, 74, 73) | 1.587 Liters | Standard Error 0.0248 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, 15 minutes (n=121, 62, 57) | 1.387 Liters | Standard Error 0.0371 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 5 (n=123, 62, 64) | 1.415 Liters | Standard Error 0.0352 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 15 (n=129, 71, 72) | 1.481 Liters | Standard Error 0.0255 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 15 (n=121, 61, 61) | 1.464 Liters | Standard Error 0.0358 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 30 (n=125, 65, 63) | 1.502 Liters | Standard Error 0.035 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 30 (n=125, 64, 64) | 1.439 Liters | Standard Error 0.0359 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 15 (n=124, 65, 63) | 1.479 Liters | Standard Error 0.0356 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 22 (n=118, 60, 52) | 1.282 Liters | Standard Error 0.0396 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 1 (n=127, 64, 64) | 1.462 Liters | Standard Error 0.0349 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 5 (n=125, 66, 63) | 1.453 Liters | Standard Error 0.0351 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 12 (n=130, 69, 70) | 1.480 Liters | Standard Error 0.0306 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 2 (n=124, 64, 63) | 1.520 Liters | Standard Error 0.0395 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 30 (n=125, 65, 65) | 1.535 Liters | Standard Error 0.0368 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 2 (n=144, 75, 75) | 1.569 Liters | Standard Error 0.0247 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 3 (n=124, 64, 64) | 1.555 Liters | Standard Error 0.038 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 15 (n=124, 65, 65) | 1.530 Liters | Standard Error 0.0377 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 5 (n=123, 65, 64) | 1.515 Liters | Standard Error 0.0359 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 4 (n=124, 64, 62) | 1.519 Liters | Standard Error 0.0377 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 45 (n=124, 65, 63) | 1.488 Liters | Standard Error 0.0374 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 16 (n=117, 53, 46) | 1.329 Liters | Standard Error 0.042 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 15 (n=120, 55, 61) | 1.416 Liters | Standard Error 0.0399 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 15 (n=126, 66, 67) | 1.520 Liters | Standard Error 0.0335 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 1 (n=144, 76, 75) | 1.514 Liters | Standard Error 0.0212 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 45 (n=117, 56, 61) | 1.405 Liters | Standard Error 0.0376 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 22 (n=117, 60, 63) | 1.371 Liters | Standard Error 0.0333 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 5 (n=135, 74, 74) | 1.447 Liters | Standard Error 0.0164 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 5 (n=125, 62, 63) | 1.407 Liters | Standard Error 0.0372 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 16 (n=109, 56, 57) | 1.378 Liters | Standard Error 0.0404 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 30 (n=143, 77, 74) | 1.483 Liters | Standard Error 0.0219 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 15 (n=123, 62, 63) | 1.425 Liters | Standard Error 0.0379 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 12 (n=122, 58, 68) | 1.487 Liters | Standard Error 0.0382 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day1, hour 10 (n=134, 72, 75) | 1.537 Liters | Standard Error 0.0286 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 30 (n=125, 62, 62) | 1.452 Liters | Standard Error 0.0385 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 10 (n=124, 61, 69) | 1.532 Liters | Standard Error 0.0365 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 8 (n=137, 70, 75) | 1.545 Liters | Standard Error 0.0278 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, hour 1 (n=125, 62, 63) | 1.472 Liters | Standard Error 0.0361 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 8 (n=121, 64, 69) | 1.479 Liters | Standard Error 0.0374 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 5 (n=119, 61, 58) | 1.490 Liters | Standard Error 0.0394 |
Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52
FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.
Time frame: 5, 15, and 30 minutes; and 1, 2, 3, 4 hours post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52
Population: Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 3 (n=400, 186, 199) | 1.525 Liters | Standard Error 0.0171 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 15 (n=430, 207, 220) | 1.525 Liters | Standard Error 0.0164 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 30 (n=433, 209, 220) | 1.546 Liters | Standard Error 0.016 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 2 (n=402, 186, 202) | 1.526 Liters | Standard Error 0.0177 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 30 (n=431, 207, 221) | 1.544 Liters | Standard Error 0.0164 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 15 (n=479, 222, 234) | 1.538 Liters | Standard Error 0.0126 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 1 (n=404, 190, 201) | 1.499 Liters | Standard Error 0.0161 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 5 (421, 202, 213) | 1.479 Liters | Standard Error 0.0153 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 30 (n=402, 189, 202) | 1.471 Liters | Standard Error 0.0164 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 15 (n=394, 183, 200) | 1.471 Liters | Standard Error 0.0159 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 15 (n=414, 200, 207) | 1.504 Liters | Standard Error 0.0155 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 1 (n=511, 256, 254) | 1.552 Liters | Standard Error 0.0082 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 30 (n=392, 186, 204) | 1.504 Liters | Standard Error 0.0166 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 15 (n=391, 187, 203) | 1.496 Liters | Standard Error 0.0156 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 1 (n=425, 206, 212) | 1.541 Liters | Standard Error 0.016 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 15 (n=428, 209, 219) | 1.530 Liters | Standard Error 0.0155 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 5 (n=386, 185, 199) | 1.454 Liters | Standard Error 0.0155 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 2 (n=420, 203, 208) | 1.570 Liters | Standard Error 0.0176 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 30 (n=480, 223, 234) | 1.564 Liters | Standard Error 0.0129 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 3 (n=416, 204, 213) | 1.570 Liters | Standard Error 0.0181 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 5 (n=498, 223, 243) | 1.491 Liters | Standard Error 0.0123 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 30 (n=405, 189, 201) | 1.518 Liters | Standard Error 0.0183 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 4 (n=416, 203, 208) | 1.547 Liters | Standard Error 0.0175 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 5 (n=453, 212, 230) | 1.502 Liters | Standard Error 0.0136 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 5 (n=454, 217, 227) | 1.529 Liters | Standard Error 0.0126 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 15 (n=405, 188, 201) | 1.511 Liters | Standard Error 0.0171 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 45 (n=401, 185, 198) | 1.474 Liters | Standard Error 0.0175 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 15 (n=502, 255, 254) | 1.501 Liters | Standard Error 0.0074 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 5 (n=398, 189, 199) | 1.489 Liters | Standard Error 0.0172 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 15 (n=407, 191, 214) | 1.508 Liters | Standard Error 0.0172 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 15 (n=459, 220, 225) | 1.550 Liters | Standard Error 0.0132 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 30 (n=410, 196, 215) | 1.518 Liters | Standard Error 0.0172 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 15 (n=487, 229, 239) | 1.527 Liters | Standard Error 0.0123 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 30 (n=460, 220, 226) | 1.569 Liters | Standard Error 0.0125 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 5 (n=401, 188, 197) | 1.436 Liters | Standard Error 0.0155 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 15 (n=481, 243, 239) | 1.459 Liters | Standard Error 0.0093 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 15 (n=448, 205, 222) | 1.527 Liters | Standard Error 0.0131 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 5 (n=408, 194, 212) | 1.481 Liters | Standard Error 0.0167 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 4 (n=504, 239, 250) | 1.590 Liters | Standard Error 0.0095 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 30 (n=455, 212, 226) | 1.522 Liters | Standard Error 0.0139 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 30 (n=503, 233, 242) | 1.538 Liters | Standard Error 0.0122 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 3 (n=510, 248, 252) | 1.590 Liters | Standard Error 0.0088 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 1 (n=455, 210, 227) | 1.556 Liters | Standard Error 0.0139 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 2 (n=513, 253, 252) | 1.612 Liters | Standard Error 0.009 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 30 (n=507, 252, 254) | 1.524 Liters | Standard Error 0.0103 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 2 (n=446, 207, 225) | 1.595 Liters | Standard Error 0.0145 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 15 (n=405, 187, 202) | 1.464 Liters | Standard Error 0.0175 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 5 (n=495, 255, 253) | 1.443 Liters | Standard Error 0.0067 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 3 (n=444, 204, 225) | 1.592 Liters | Standard Error 0.0145 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 4 (n=437, 202, 224) | 1.558 Liters | Standard Error 0.0152 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, hour 1 (n=501, 229, 240) | 1.561 Liters | Standard Error 0.0121 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, minute 45 (n=395, 185, 199) | 1.424 Liters | Standard Error 0.0165 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 15 (n=430, 200, 214) | 1.481 Liters | Standard Error 0.0143 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, hour 1 (n=412, 195, 215) | 1.534 Liters | Standard Error 0.0171 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, minute 15 (n=388, 183, 198) | 1.419 Liters | Standard Error 0.0169 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 45 (n=426, 195, 205) | 1.493 Liters | Standard Error 0.0149 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 5 (n=429, 207, 218) | 1.514 Liters | Standard Error 0.0151 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 30 (n=424, 206, 213) | 1.513 Liters | Standard Error 0.0161 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 5 (n=476, 221, 231) | 1.509 Liters | Standard Error 0.0125 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 4 (n=397, 184, 199) | 1.504 Liters | Standard Error 0.0176 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 5 (n=430, 206, 218) | 1.495 Liters | Standard Error 0.0159 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 45 (n=474, 239, 232) | 1.482 Liters | Standard Error 0.0094 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 5 (421, 202, 213) | 1.339 Liters | Standard Error 0.0189 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 15 (n=502, 255, 254) | 1.359 Liters | Standard Error 0.009 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 1 (n=511, 256, 254) | 1.353 Liters | Standard Error 0.0101 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 45 (n=474, 239, 232) | 1.390 Liters | Standard Error 0.0117 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 5 (n=498, 223, 243) | 1.368 Liters | Standard Error 0.0157 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 15 (n=487, 229, 239) | 1.371 Liters | Standard Error 0.0154 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 30 (n=503, 233, 242) | 1.368 Liters | Standard Error 0.0152 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, hour 1 (n=501, 229, 240) | 1.379 Liters | Standard Error 0.0153 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 5 (n=476, 221, 231) | 1.371 Liters | Standard Error 0.0161 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 15 (n=479, 222, 234) | 1.389 Liters | Standard Error 0.0162 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 30 (n=480, 223, 234) | 1.396 Liters | Standard Error 0.0165 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 5 (n=454, 217, 227) | 1.366 Liters | Standard Error 0.0159 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 5 (n=453, 212, 230) | 1.349 Liters | Standard Error 0.0173 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 15 (n=448, 205, 222) | 1.352 Liters | Standard Error 0.0171 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 30 (n=455, 212, 226) | 1.352 Liters | Standard Error 0.0176 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 1 (n=455, 210, 227) | 1.364 Liters | Standard Error 0.0178 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 2 (n=446, 207, 225) | 1.423 Liters | Standard Error 0.0185 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 4 (n=437, 202, 224) | 1.416 Liters | Standard Error 0.0193 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 15 (n=430, 200, 214) | 1.381 Liters | Standard Error 0.0183 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 5 (n=429, 207, 218) | 1.373 Liters | Standard Error 0.0185 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 30 (n=433, 209, 220) | 1.372 Liters | Standard Error 0.0194 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 5 (n=430, 206, 218) | 1.351 Liters | Standard Error 0.0198 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 15 (n=430, 207, 220) | 1.362 Liters | Standard Error 0.0203 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 30 (n=431, 207, 221) | 1.362 Liters | Standard Error 0.0203 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 15 (n=414, 200, 207) | 1.340 Liters | Standard Error 0.0193 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 1 (n=425, 206, 212) | 1.345 Liters | Standard Error 0.0193 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 2 (n=420, 203, 208) | 1.388 Liters | Standard Error 0.0212 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 3 (n=416, 204, 213) | 1.398 Liters | Standard Error 0.0216 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 4 (n=416, 203, 208) | 1.384 Liters | Standard Error 0.0211 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 15 (n=405, 187, 202) | 1.326 Liters | Standard Error 0.0217 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 45 (n=401, 185, 198) | 1.354 Liters | Standard Error 0.0218 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 15 (n=407, 191, 214) | 1.333 Liters | Standard Error 0.0215 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 5 (n=398, 189, 199) | 1.342 Liters | Standard Error 0.0218 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 15 (n=405, 188, 201) | 1.344 Liters | Standard Error 0.0218 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 30 (n=405, 189, 201) | 1.350 Liters | Standard Error 0.0229 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 5 (n=386, 185, 199) | 1.336 Liters | Standard Error 0.0197 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 15 (n=391, 187, 203) | 1.341 Liters | Standard Error 0.0199 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 30 (n=392, 186, 204) | 1.341 Liters | Standard Error 0.021 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 5 (n=401, 188, 197) | 1.305 Liters | Standard Error 0.02 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 15 (n=394, 183, 200) | 1.323 Liters | Standard Error 0.0208 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 30 (n=402, 189, 202) | 1.319 Liters | Standard Error 0.0209 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 1 (n=404, 190, 201) | 1.325 Liters | Standard Error 0.0205 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 2 (n=402, 186, 202) | 1.363 Liters | Standard Error 0.0224 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 3 (n=400, 186, 199) | 1.344 Liters | Standard Error 0.0215 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 4 (n=397, 184, 199) | 1.346 Liters | Standard Error 0.0222 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, minute 15 (n=388, 183, 198) | 1.303 Liters | Standard Error 0.0215 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, minute 45 (n=395, 185, 199) | 1.320 Liters | Standard Error 0.021 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 5 (n=495, 255, 253) | 1.357 Liters | Standard Error 0.0081 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 30 (n=507, 252, 254) | 1.357 Liters | Standard Error 0.0126 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 2 (n=513, 253, 252) | 1.397 Liters | Standard Error 0.0113 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 3 (n=510, 248, 252) | 1.389 Liters | Standard Error 0.0111 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 4 (n=504, 239, 250) | 1.396 Liters | Standard Error 0.0121 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 15 (n=481, 243, 239) | 1.364 Liters | Standard Error 0.0115 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 15 (n=459, 220, 225) | 1.376 Liters | Standard Error 0.0164 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 30 (n=460, 220, 226) | 1.378 Liters | Standard Error 0.0158 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 3 (n=444, 204, 225) | 1.414 Liters | Standard Error 0.0186 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 45 (n=426, 195, 205) | 1.413 Liters | Standard Error 0.019 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 15 (n=428, 209, 219) | 1.372 Liters | Standard Error 0.0189 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 30 (n=424, 206, 213) | 1.341 Liters | Standard Error 0.0196 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 5 (n=408, 194, 212) | 1.338 Liters | Standard Error 0.021 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 30 (n=410, 196, 215) | 1.331 Liters | Standard Error 0.0214 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, hour 1 (n=412, 195, 215) | 1.331 Liters | Standard Error 0.0213 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 1 (n=404, 190, 201) | 1.482 Liters | Standard Error 0.0198 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 15 (n=430, 207, 220) | 1.495 Liters | Standard Error 0.0196 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 45 (n=426, 195, 205) | 1.472 Liters | Standard Error 0.0187 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 2 (n=402, 186, 202) | 1.511 Liters | Standard Error 0.0214 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 5 (n=430, 206, 218) | 1.464 Liters | Standard Error 0.0192 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 5 (n=429, 207, 218) | 1.487 Liters | Standard Error 0.0181 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 3 (n=400, 186, 199) | 1.509 Liters | Standard Error 0.0207 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 30 (n=433, 209, 220) | 1.505 Liters | Standard Error 0.019 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 15 (n=479, 222, 234) | 1.508 Liters | Standard Error 0.0157 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 4 (n=397, 184, 199) | 1.501 Liters | Standard Error 0.0213 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 15 (n=430, 200, 214) | 1.457 Liters | Standard Error 0.0177 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 30 (n=410, 196, 215) | 1.444 Liters | Standard Error 0.0206 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 4 (n=437, 202, 224) | 1.534 Liters | Standard Error 0.0183 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 15 (n=428, 209, 219) | 1.491 Liters | Standard Error 0.0186 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, minute 45 (n=395, 185, 199) | 1.411 Liters | Standard Error 0.0201 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 2 (n=446, 207, 225) | 1.558 Liters | Standard Error 0.0178 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 5 (n=476, 221, 231) | 1.488 Liters | Standard Error 0.0157 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 15 (n=502, 255, 254) | 1.437 Liters | Standard Error 0.009 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 1 (n=455, 210, 227) | 1.528 Liters | Standard Error 0.0171 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, hour 1 (n=501, 229, 240) | 1.525 Liters | Standard Error 0.015 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 30 (n=507, 252, 254) | 1.468 Liters | Standard Error 0.0125 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 15 (n=481, 243, 239) | 1.457 Liters | Standard Error 0.0115 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 2 (n=513, 253, 252) | 1.549 Liters | Standard Error 0.0112 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 30 (n=455, 212, 226) | 1.491 Liters | Standard Error 0.017 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 2 (n=420, 203, 208) | 1.524 Liters | Standard Error 0.021 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 3 (n=510, 248, 252) | 1.560 Liters | Standard Error 0.0109 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 15 (n=448, 205, 222) | 1.501 Liters | Standard Error 0.0166 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 4 (n=416, 203, 208) | 1.504 Liters | Standard Error 0.0208 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 4 (n=504, 239, 250) | 1.549 Liters | Standard Error 0.0117 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 5 (n=453, 212, 230) | 1.477 Liters | Standard Error 0.0167 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 30 (n=503, 233, 242) | 1.504 Liters | Standard Error 0.015 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 45 (n=474, 239, 232) | 1.473 Liters | Standard Error 0.0118 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 15 (n=407, 191, 214) | 1.443 Liters | Standard Error 0.0206 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, hour 1 (n=412, 195, 215) | 1.464 Liters | Standard Error 0.0205 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 5 (n=408, 194, 212) | 1.422 Liters | Standard Error 0.0202 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 5 (n=498, 223, 243) | 1.472 Liters | Standard Error 0.0151 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 5 (n=398, 189, 199) | 1.459 Liters | Standard Error 0.0213 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 15 (n=405, 187, 202) | 1.415 Liters | Standard Error 0.0212 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 15 (n=459, 220, 225) | 1.515 Liters | Standard Error 0.0163 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 15 (n=405, 188, 201) | 1.477 Liters | Standard Error 0.0211 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 3 (n=416, 204, 213) | 1.526 Liters | Standard Error 0.0211 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 5 (n=454, 217, 227) | 1.499 Liters | Standard Error 0.0157 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 30 (n=405, 189, 201) | 1.496 Liters | Standard Error 0.0222 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 1 (n=425, 206, 212) | 1.487 Liters | Standard Error 0.019 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 45 (n=401, 185, 198) | 1.426 Liters | Standard Error 0.0215 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 5 (n=386, 185, 199) | 1.429 Liters | Standard Error 0.019 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 30 (n=424, 206, 213) | 1.451 Liters | Standard Error 0.0193 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 15 (n=487, 229, 239) | 1.514 Liters | Standard Error 0.0151 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 15 (n=391, 187, 203) | 1.462 Liters | Standard Error 0.0192 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 15 (n=414, 200, 207) | 1.458 Liters | Standard Error 0.0191 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 30 (n=460, 220, 226) | 1.531 Liters | Standard Error 0.0157 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 30 (n=392, 186, 204) | 1.475 Liters | Standard Error 0.02 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 30 (n=480, 223, 234) | 1.525 Liters | Standard Error 0.016 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 5 (n=401, 188, 197) | 1.419 Liters | Standard Error 0.0195 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 5 (421, 202, 213) | 1.429 Liters | Standard Error 0.0185 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, minute 15 (n=388, 183, 198) | 1.397 Liters | Standard Error 0.0205 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 15 (n=394, 183, 200) | 1.451 Liters | Standard Error 0.0198 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 5 (n=495, 255, 253) | 1.402 Liters | Standard Error 0.0081 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 3 (n=444, 204, 225) | 1.561 Liters | Standard Error 0.0177 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 30 (n=402, 189, 202) | 1.451 Liters | Standard Error 0.0202 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 30 (n=431, 207, 221) | 1.498 Liters | Standard Error 0.0195 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 1 (n=511, 256, 254) | 1.484 Liters | Standard Error 0.0101 |
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, 4, 6, 8 10, and 12 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.
Time frame: From 5 minutes to 12 hours post-dose at Day 1 and Weeks 12 and 52
Population: Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52 | Week 12 (n=133, 69, 70) | 1.539 Liters | Standard Error 0.0261 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52 | Week 52 (n=125, 62, 58) | 1.492 Liters | Standard Error 0.0265 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52 | Day 1 | 1.566 Liters | Standard Error 0.0168 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52 | Week 12 (n=133, 69, 70) | 1.398 Liters | Standard Error 0.0324 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52 | Week 52 (n=125, 62, 58) | 1.364 Liters | Standard Error 0.0352 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52 | Day 1 | 1.407 Liters | Standard Error 0.0207 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52 | Week 52 (n=125, 62, 58) | 1.424 Liters | Standard Error 0.0344 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52 | Week 12 (n=133, 69, 70) | 1.505 Liters | Standard Error 0.032 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52 | Day 1 | 1.534 Liters | Standard Error 0.0206 |
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes and From 12 Hours to 23 Hours 45 Minutes Post-dose at Weeks 12 and 52
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.
Time frame: From 5 minutes to 23 hours 45 minutes post-dose at Weeks 12 and 52
Population: Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes and From 12 Hours to 23 Hours 45 Minutes Post-dose at Weeks 12 and 52 | Week 12 | 1.486 Liters | Standard Error 0.0236 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes and From 12 Hours to 23 Hours 45 Minutes Post-dose at Weeks 12 and 52 | Week 52 (n=125, 62, 58) | 1.445 Liters | Standard Error 0.0261 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes and From 12 Hours to 23 Hours 45 Minutes Post-dose at Weeks 12 and 52 | Week 12 | 1.380 Liters | Standard Error 0.0298 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes and From 12 Hours to 23 Hours 45 Minutes Post-dose at Weeks 12 and 52 | Week 52 (n=125, 62, 58) | 1.339 Liters | Standard Error 0.0346 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes and From 12 Hours to 23 Hours 45 Minutes Post-dose at Weeks 12 and 52 | Week 12 | 1.459 Liters | Standard Error 0.0294 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes and From 12 Hours to 23 Hours 45 Minutes Post-dose at Weeks 12 and 52 | Week 52 (n=125, 62, 58) | 1.379 Liters | Standard Error 0.0338 |
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, and 4 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.
Time frame: From 5 minutes to 4 hours post-dose at Day 1 and Weeks 12, 26, and 52
Population: Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52 | Week 52 (n=405, 192, 203) | 1.502 Liters | Standard Error 0.0162 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52 | Week 26 (n=430, 206, 216) | 1.546 Liters | Standard Error 0.016 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52 | Week 12 (n=460, 214, 232) | 1.560 Liters | Standard Error 0.0134 |
| Glycopyrronium Bromide 50 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52 | Day 1 | 1.570 Liters | Standard Error 0.0075 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52 | Week 12 (n=460, 214, 232) | 1.384 Liters | Standard Error 0.017 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52 | Day 1 | 1.373 Liters | Standard Error 0.0092 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52 | Week 26 (n=430, 206, 216) | 1.369 Liters | Standard Error 0.0194 |
| Placebo to Glycopyrronium Bromide | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52 | Week 52 (n=405, 192, 203) | 1.336 Liters | Standard Error 0.0203 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52 | Week 26 (n=430, 206, 216) | 1.495 Liters | Standard Error 0.019 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52 | Day 1 | 1.514 Liters | Standard Error 0.0092 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52 | Week 12 (n=460, 214, 232) | 1.531 Liters | Standard Error 0.0164 |
| Tiotropium 18 μg | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52 | Week 52 (n=405, 192, 203) | 1.487 Liters | Standard Error 0.0196 |
Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52
Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told At the end of the next normal breath out, take a deep breath all the way in; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.
Time frame: 5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52
Population: Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 15 (n=124, 65, 63) | 3.112 Liters | Standard Error 0.0545 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 30 (n=125, 64, 64) | 3.054 Liters | Standard Error 0.0464 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 2 (n=124, 64, 63) | 3.110 Liters | Standard Error 0.0516 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 3 (n=124, 64, 64) | 3.210 Liters | Standard Error 0.0648 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 30 (n=125, 62, 62) | 3.081 Liters | Standard Error 0.0555 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 15 (n=123, 61, 58) | 3.022 Liters | Standard Error 0.0539 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 5 (n=120, 60, 57) | 3.022 Liters | Standard Error 0.0596 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 15 (n=123, 60, 57) | 3.042 Liters | Standard Error 0.0592 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 30 (n=125, 62, 58) | 2.939 Liters | Standard Error 0.0499 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 1 (n=125, 62, 57) | 3.031 Liters | Standard Error 0.0564 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 2 (n=124, 61, 58) | 3.062 Liters | Standard Error 0.0556 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 6 (n=118, 59, 54) | 2.986 Liters | Standard Error 0.0614 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 10 (n=119, 59, 55) | 3.000 Liters | Standard Error 0.0701 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 12 (n=120, 58, 52) | 2.881 Liters | Standard Error 0.0631 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 16 (n=117, 53, 46) | 2.857 Liters | Standard Error 0.0694 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 5 (n=135, 74, 74) | 3.027 Liters | Standard Error 0.0304 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 15 (n=139, 75, 74) | 3.050 Liters | Standard Error 0.0335 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 12 (n=130, 69, 70) | 3.030 Liters | Standard Error 0.0444 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 15 (n=136, 67, 70) | 3.165 Liters | Standard Error 0.0501 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 30 (n=135, 67, 70) | 3.248 Liters | Standard Error 0.054 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 5 (n=128, 66, 70) | 3.195 Liters | Standard Error 0.0543 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 30 (n=130, 67, 71) | 3.231 Liters | Standard Error 0.0567 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 5 (n=130, 69, 70) | 3.060 Liters | Standard Error 0.0492 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 15 (n=129, 67, 66) | 3.081 Liters | Standard Error 0.0482 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 1 (n=132, 67, 69) | 3.164 Liters | Standard Error 0.0543 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 2 (n=129, 65, 68) | 3.190 Liters | Standard Error 0.0526 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 3 (n=126, 64, 69) | 3.240 Liters | Standard Error 0.0569 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 6 (n=123, 63, 69) | 3.158 Liters | Standard Error 0.0594 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 10 (n=124, 61, 69) | 3.130 Liters | Standard Error 0.0581 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 30 (n=125, 65, 63) | 3.157 Liters | Standard Error 0.0559 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 5 (n=123, 62, 64) | 2.994 Liters | Standard Error 0.0528 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 15 (n=121, 61, 61) | 3.041 Liters | Standard Error 0.0513 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 1 (n=127, 64, 64) | 3.077 Liters | Standard Error 0.052 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 4 (n=124, 64, 62) | 3.111 Liters | Standard Error 0.0551 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 15 (n=120, 55, 61) | 3.056 Liters | Standard Error 0.06 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 45 (n=117, 56, 61) | 2.998 Liters | Standard Error 0.0512 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 5 (n=125, 62, 63) | 3.023 Liters | Standard Error 0.0573 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 15 (n=123, 62, 63) | 3.016 Liters | Standard Error 0.0553 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, hour 1 (n=125, 62, 63) | 3.072 Liters | Standard Error 0.0564 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 5 (n=119, 61, 58) | 3.033 Liters | Standard Error 0.0583 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 30 (n=123, 61, 58) | 3.057 Liters | Standard Error 0.0565 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 30 (n=123, 60, 58) | 3.094 Liters | Standard Error 0.0613 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 5 (n=124, 60, 57) | 2.940 Liters | Standard Error 0.0551 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 15 (n=122, 59, 58) | 2.960 Liters | Standard Error 0.0518 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 3 (n=123, 62, 56) | 3.108 Liters | Standard Error 0.0648 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 4 (n=121, 60, 55) | 3.021 Liters | Standard Error 0.0585 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 8 (n=119, 59, 54) | 2.961 Liters | Standard Error 0.0646 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 22 (n=118, 60, 52) | 2.812 Liters | Standard Error 0.067 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, 15 minutes (n=121, 62, 57) | 2.888 Liters | Standard Error 0.0595 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, 45 minutes (n=122, 61, 57) | 2.855 Liters | Standard Error 0.0558 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 30 (n=143, 77, 74) | 3.055 Liters | Standard Error 0.0343 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 1 (n=144, 76, 75) | 3.148 Liters | Standard Error 0.0377 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 2 (n=144, 75, 75) | 3.179 Liters | Standard Error 0.0373 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 3 (n=143, 74, 73) | 3.190 Liters | Standard Error 0.0433 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 4 (n=144, 70, 74) | 3.138 Liters | Standard Error 0.0414 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 6 (n=142, 71, 74) | 3.173 Liters | Standard Error 0.0419 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 8 (n=137, 70, 75) | 3.071 Liters | Standard Error 0.0404 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day1, hour 10 (n=134, 72, 75) | 3.134 Liters | Standard Error 0.0414 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 15 (n=129, 71, 72) | 2.991 Liters | Standard Error 0.0385 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 45 (n=128, 74, 75) | 3.014 Liters | Standard Error 0.0364 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 5 (n=135, 65, 73) | 3.051 Liters | Standard Error 0.0439 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 15 (n=133, 70, 72) | 3.103 Liters | Standard Error 0.0443 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 30 (n= 139, 70, 74) | 3.134 Liters | Standard Error 0.042 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, hour 1 (n=140, 68, 74) | 3.152 Liters | Standard Error 0.0434 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 5 (n=134, 66, 68) | 3.139 Liters | Standard Error 0.043 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 15 (n=130, 66, 71) | 3.167 Liters | Standard Error 0.0507 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 30 (n=133, 69, 67) | 3.058 Liters | Standard Error 0.0479 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 4 (n=124, 64, 68) | 3.119 Liters | Standard Error 0.0576 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 8 (n=121, 64, 69) | 3.083 Liters | Standard Error 0.0534 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 12 (n=122, 58, 68) | 3.072 Liters | Standard Error 0.0599 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 16 (n=109, 56, 57) | 2.933 Liters | Standard Error 0.0645 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 22 (n=117, 60, 63) | 2.924 Liters | Standard Error 0.0517 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 15 (n=126, 66, 67) | 3.091 Liters | Standard Error 0.0548 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 45 (n=124, 65, 63) | 3.055 Liters | Standard Error 0.0507 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 5 (n=123, 65, 64) | 3.156 Liters | Standard Error 0.0608 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 15 (n=124, 65, 65) | 3.156 Liters | Standard Error 0.0576 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 30 (n=125, 65, 65) | 3.198 Liters | Standard Error 0.0552 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 5 (n=125, 66, 63) | 3.093 Liters | Standard Error 0.0526 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 5 (n=125, 66, 63) | 2.781 Liters | Standard Error 0.063 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 1 (n=144, 76, 75) | 2.791 Liters | Standard Error 0.046 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 30 (n=125, 64, 64) | 2.700 Liters | Standard Error 0.0597 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 15 (n=123, 62, 63) | 2.731 Liters | Standard Error 0.0691 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 1 (n=127, 64, 64) | 2.678 Liters | Standard Error 0.0658 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 30 (n=125, 65, 65) | 2.815 Liters | Standard Error 0.0676 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 15 (n=126, 66, 67) | 2.862 Liters | Standard Error 0.0676 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 2 (n=124, 64, 63) | 2.771 Liters | Standard Error 0.0655 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 30 (n=125, 65, 63) | 2.778 Liters | Standard Error 0.0677 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 6 (n=123, 63, 69) | 2.852 Liters | Standard Error 0.0731 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 15 (n=130, 66, 71) | 2.823 Liters | Standard Error 0.0615 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 15 (n=120, 55, 61) | 2.803 Liters | Standard Error 0.0749 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 45 (n=117, 56, 61) | 2.752 Liters | Standard Error 0.0667 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 15 (n=133, 70, 72) | 2.790 Liters | Standard Error 0.0536 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 2 (n=144, 75, 75) | 2.802 Liters | Standard Error 0.046 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 30 (n=125, 62, 62) | 2.687 Liters | Standard Error 0.0715 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, hour 1 (n=125, 62, 63) | 2.703 Liters | Standard Error 0.0707 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 5 (n=123, 62, 64) | 2.700 Liters | Standard Error 0.067 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 5 (n=119, 61, 58) | 2.716 Liters | Standard Error 0.0744 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 15 (n=123, 60, 57) | 2.702 Liters | Standard Error 0.0726 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 8 (n=121, 64, 69) | 2.760 Liters | Standard Error 0.0657 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 15 (n=123, 61, 58) | 2.695 Liters | Standard Error 0.0706 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 45 (n=128, 74, 75) | 2.817 Liters | Standard Error 0.0444 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 30 (n=123, 61, 58) | 2.723 Liters | Standard Error 0.0734 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 15 (n=124, 65, 65) | 2.801 Liters | Standard Error 0.0695 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 5 (n=120, 60, 57) | 2.731 Liters | Standard Error 0.0727 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 3 (n=143, 74, 73) | 2.826 Liters | Standard Error 0.0526 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 30 (n=123, 60, 58) | 2.731 Liters | Standard Error 0.0749 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 15 (n=121, 61, 61) | 2.692 Liters | Standard Error 0.0652 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 5 (n=124, 60, 57) | 2.645 Liters | Standard Error 0.0701 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 5 (n=135, 65, 73) | 2.793 Liters | Standard Error 0.0553 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 1 (n=132, 67, 69) | 2.737 Liters | Standard Error 0.0663 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 4 (n=144, 70, 74) | 2.783 Liters | Standard Error 0.0515 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 2 (n=124, 61, 58) | 2.714 Liters | Standard Error 0.0689 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 15 (n=122, 59, 58) | 2.640 Liters | Standard Error 0.0675 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 4 (n=121, 60, 55) | 2.694 Liters | Standard Error 0.0724 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 30 (n=125, 62, 58) | 2.625 Liters | Standard Error 0.065 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 1 (n=125, 62, 57) | 2.617 Liters | Standard Error 0.0698 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 6 (n=118, 59, 54) | 2.690 Liters | Standard Error 0.077 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 3 (n=124, 64, 64) | 2.871 Liters | Standard Error 0.0765 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 8 (n=119, 59, 54) | 2.637 Liters | Standard Error 0.0793 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 10 (n=124, 61, 69) | 2.860 Liters | Standard Error 0.0722 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 16 (n=109, 56, 57) | 2.701 Liters | Standard Error 0.08 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 10 (n=119, 59, 55) | 2.687 Liters | Standard Error 0.084 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 3 (n=123, 62, 56) | 2.716 Liters | Standard Error 0.0766 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 6 (n=142, 71, 74) | 2.846 Liters | Standard Error 0.0514 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 12 (n=120, 58, 52) | 2.636 Liters | Standard Error 0.0831 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 4 (n=124, 64, 62) | 2.791 Liters | Standard Error 0.0664 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 22 (n=118, 60, 52) | 2.604 Liters | Standard Error 0.081 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, 15 minutes (n=121, 62, 57) | 2.678 Liters | Standard Error 0.0751 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 2 (n=129, 65, 68) | 2.784 Liters | Standard Error 0.0664 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 3 (n=126, 64, 69) | 2.864 Liters | Standard Error 0.0713 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 12 (n=122, 58, 68) | 2.771 Liters | Standard Error 0.077 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 8 (n=137, 70, 75) | 2.804 Liters | Standard Error 0.0506 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 15 (n=139, 75, 74) | 2.802 Liters | Standard Error 0.0403 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 16 (n=117, 53, 46) | 2.542 Liters | Standard Error 0.0857 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 30 (n=133, 69, 67) | 2.696 Liters | Standard Error 0.0585 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 12 (n=130, 69, 70) | 2.709 Liters | Standard Error 0.0535 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 15 (n=129, 67, 66) | 2.740 Liters | Standard Error 0.0588 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 5 (n=123, 65, 64) | 2.864 Liters | Standard Error 0.0719 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 30 (n= 139, 70, 74) | 2.825 Liters | Standard Error 0.0519 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, hour 1 (n=140, 68, 74) | 2.770 Liters | Standard Error 0.0537 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 45 (n=124, 65, 63) | 2.826 Liters | Standard Error 0.063 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 15 (n=136, 67, 70) | 2.850 Liters | Standard Error 0.0611 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 5 (n=125, 62, 63) | 2.731 Liters | Standard Error 0.0715 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day1, hour 10 (n=134, 72, 75) | 2.865 Liters | Standard Error 0.0514 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 30 (n=135, 67, 70) | 2.884 Liters | Standard Error 0.0644 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 4 (n=124, 64, 68) | 2.745 Liters | Standard Error 0.0714 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, 45 minutes (n=122, 61, 57) | 2.607 Liters | Standard Error 0.07 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 5 (n=128, 66, 70) | 2.826 Liters | Standard Error 0.0644 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 5 (n=135, 74, 74) | 2.826 Liters | Standard Error 0.0363 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 15 (n=124, 65, 63) | 2.770 Liters | Standard Error 0.0655 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 30 (n=130, 67, 71) | 2.821 Liters | Standard Error 0.0675 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 30 (n=143, 77, 74) | 2.752 Liters | Standard Error 0.0416 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 22 (n=117, 60, 63) | 2.673 Liters | Standard Error 0.0647 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 5 (n=130, 69, 70) | 2.728 Liters | Standard Error 0.0596 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 5 (n=134, 66, 68) | 2.866 Liters | Standard Error 0.0551 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 15 (n=129, 71, 72) | 2.800 Liters | Standard Error 0.0478 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 45 (n=128, 74, 75) | 2.994 Liters | Standard Error 0.0442 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 15 (n=129, 67, 66) | 3.018 Liters | Standard Error 0.0593 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 30 (n=133, 69, 67) | 3.027 Liters | Standard Error 0.0591 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 15 (n=129, 71, 72) | 2.988 Liters | Standard Error 0.0471 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 22 (n=117, 60, 63) | 2.870 Liters | Standard Error 0.0629 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 2 (n=129, 65, 68) | 3.155 Liters | Standard Error 0.0649 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 4 (n=124, 64, 68) | 3.084 Liters | Standard Error 0.0686 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 8 (n=121, 64, 69) | 3.011 Liters | Standard Error 0.0644 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 12 (n=122, 58, 68) | 3.020 Liters | Standard Error 0.0722 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 15 (n=124, 65, 63) | 3.029 Liters | Standard Error 0.0666 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 30 (n=125, 65, 63) | 3.050 Liters | Standard Error 0.0688 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 5 (n=123, 62, 64) | 2.954 Liters | Standard Error 0.0658 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 15 (n=133, 70, 72) | 3.103 Liters | Standard Error 0.0536 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 15 (n=126, 66, 67) | 3.110 Liters | Standard Error 0.0671 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 30 (n= 139, 70, 74) | 3.078 Liters | Standard Error 0.0513 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 4 (n=124, 64, 62) | 3.086 Liters | Standard Error 0.0664 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 30 (n=125, 65, 65) | 3.112 Liters | Standard Error 0.0679 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 15 (n=120, 55, 61) | 2.932 Liters | Standard Error 0.0721 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 5 (n=125, 62, 63) | 2.881 Liters | Standard Error 0.0706 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 15 (n=123, 62, 63) | 2.898 Liters | Standard Error 0.0683 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 30 (n=125, 62, 62) | 2.971 Liters | Standard Error 0.0708 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 5 (n=134, 66, 68) | 3.071 Liters | Standard Error 0.0534 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 45 (n=124, 65, 63) | 3.004 Liters | Standard Error 0.0638 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 30 (n=123, 61, 58) | 3.098 Liters | Standard Error 0.0734 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 5 (n=120, 60, 57) | 2.963 Liters | Standard Error 0.0726 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 15 (n=123, 60, 57) | 2.937 Liters | Standard Error 0.0725 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 15 (n=130, 66, 71) | 3.101 Liters | Standard Error 0.0603 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 15 (n=121, 61, 61) | 2.976 Liters | Standard Error 0.0644 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 5 (n=124, 60, 57) | 2.860 Liters | Standard Error 0.0702 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 1 (n=125, 62, 57) | 2.980 Liters | Standard Error 0.0704 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 1 (n=132, 67, 69) | 3.098 Liters | Standard Error 0.0655 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 3 (n=123, 62, 56) | 3.053 Liters | Standard Error 0.0779 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 12 (n=120, 58, 52) | 2.849 Liters | Standard Error 0.0847 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 16 (n=117, 53, 46) | 2.772 Liters | Standard Error 0.0873 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 3 (n=126, 64, 69) | 3.146 Liters | Standard Error 0.0685 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 22 (n=118, 60, 52) | 2.716 Liters | Standard Error 0.0827 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 5 (n=123, 65, 64) | 3.104 Liters | Standard Error 0.0723 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, 15 minutes (n=121, 62, 57) | 2.852 Liters | Standard Error 0.0755 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 6 (n=123, 63, 69) | 3.120 Liters | Standard Error 0.07 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 30 (n=143, 77, 74) | 2.979 Liters | Standard Error 0.0422 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 30 (n=125, 64, 64) | 2.994 Liters | Standard Error 0.0589 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 1 (n=127, 64, 64) | 3.016 Liters | Standard Error 0.0651 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 1 (n=144, 76, 75) | 3.041 Liters | Standard Error 0.0463 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 2 (n=124, 64, 63) | 3.080 Liters | Standard Error 0.065 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 10 (n=124, 61, 69) | 3.117 Liters | Standard Error 0.0692 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 3 (n=124, 64, 64) | 3.176 Liters | Standard Error 0.0762 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 45 (n=117, 56, 61) | 2.895 Liters | Standard Error 0.0646 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, hour 1 (n=125, 62, 63) | 2.963 Liters | Standard Error 0.0699 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 5 (n=119, 61, 58) | 3.069 Liters | Standard Error 0.0746 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 2 (n=144, 75, 75) | 3.049 Liters | Standard Error 0.0461 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 15 (n=123, 61, 58) | 3.065 Liters | Standard Error 0.0699 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 30 (n=123, 60, 58) | 2.985 Liters | Standard Error 0.0747 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 15 (n=122, 59, 58) | 2.935 Liters | Standard Error 0.0666 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 3 (n=143, 74, 73) | 3.119 Liters | Standard Error 0.0531 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 30 (n=125, 62, 58) | 2.929 Liters | Standard Error 0.0652 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 15 (n=124, 65, 65) | 3.082 Liters | Standard Error 0.0699 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 2 (n=124, 61, 58) | 3.021 Liters | Standard Error 0.0689 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 4 (n=121, 60, 55) | 2.978 Liters | Standard Error 0.0735 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 4 (n=144, 70, 74) | 3.102 Liters | Standard Error 0.0512 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 6 (n=118, 59, 54) | 2.982 Liters | Standard Error 0.0781 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 8 (n=119, 59, 54) | 2.942 Liters | Standard Error 0.0805 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 10 (n=119, 59, 55) | 3.012 Liters | Standard Error 0.0844 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 6 (n=142, 71, 74) | 3.148 Liters | Standard Error 0.0513 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, 45 minutes (n=122, 61, 57) | 2.797 Liters | Standard Error 0.0702 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 16 (n=109, 56, 57) | 2.880 Liters | Standard Error 0.0785 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 5 (n=135, 74, 74) | 2.956 Liters | Standard Error 0.0363 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 15 (n=139, 75, 74) | 2.991 Liters | Standard Error 0.0406 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 8 (n=137, 70, 75) | 3.074 Liters | Standard Error 0.0498 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 5 (n=135, 65, 73) | 3.014 Liters | Standard Error 0.0534 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, hour 1 (n=140, 68, 74) | 3.060 Liters | Standard Error 0.0528 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 5 (n=125, 66, 63) | 2.993 Liters | Standard Error 0.0643 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 15 (n=136, 67, 70) | 3.092 Liters | Standard Error 0.0602 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 30 (n=135, 67, 70) | 3.180 Liters | Standard Error 0.0636 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day1, hour 10 (n=134, 72, 75) | 3.119 Liters | Standard Error 0.051 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 5 (n=128, 66, 70) | 3.097 Liters | Standard Error 0.0632 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 12 (n=130, 69, 70) | 3.012 Liters | Standard Error 0.0537 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 30 (n=130, 67, 71) | 3.149 Liters | Standard Error 0.0664 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 5 (n=130, 69, 70) | 3.023 Liters | Standard Error 0.0596 |
Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52
Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told At the end of the next normal breath out, take a deep breath all the way in; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.
Time frame: 5, 15, and 30 minutes; and 1, 2, 3, 4 hours post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52
Population: Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 1 (n=455, 210, 227) | 3.062 Liters | Standard Error 0.0267 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 5 (n=401, 188, 197) | 2.899 Liters | Standard Error 0.0309 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 45 (n=401, 185, 198) | 2.952 Liters | Standard Error 0.0305 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 2 (n=446, 207, 225) | 3.093 Liters | Standard Error 0.0266 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 45 (n=474, 239, 232) | 2.930 Liters | Standard Error 0.0178 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 15 (n=405, 187, 202) | 2.971 Liters | Standard Error 0.0321 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 3 (n=444, 204, 225) | 3.129 Liters | Standard Error 0.0275 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 4 (n=437, 202, 224) | 3.050 Liters | Standard Error 0.0278 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 1 (n=511, 256, 254) | 3.074 Liters | Standard Error 0.0173 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 4 (n=416, 203, 208) | 3.022 Liters | Standard Error 0.0312 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 15 (n=430, 200, 214) | 2.991 Liters | Standard Error 0.0282 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 3 (n=416, 204, 213) | 3.097 Liters | Standard Error 0.0331 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 45 (n=426, 195, 205) | 2.977 Liters | Standard Error 0.0268 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 30 (n=480, 223, 234) | 3.085 Liters | Standard Error 0.0243 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 2 (n=420, 203, 208) | 3.049 Liters | Standard Error 0.0308 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 5 (n=429, 207, 218) | 3.016 Liters | Standard Error 0.0301 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 5 (n=498, 223, 243) | 2.984 Liters | Standard Error 0.0222 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 1 (n=425, 206, 212) | 3.034 Liters | Standard Error 0.0293 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 15 (n=428, 209, 219) | 3.029 Liters | Standard Error 0.0293 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 15 (n=502, 255, 254) | 2.982 Liters | Standard Error 0.0164 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 30 (n=424, 206, 213) | 2.983 Liters | Standard Error 0.0282 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 30 (n=433, 209, 220) | 3.063 Liters | Standard Error 0.0298 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 15 (n=414, 200, 207) | 2.980 Liters | Standard Error 0.0298 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 5 (n=430, 206, 218) | 2.985 Liters | Standard Error 0.0286 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 15 (n=487, 229, 239) | 3.016 Liters | Standard Error 0.022 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 5 (421, 202, 213) | 2.956 Liters | Standard Error 0.0289 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 15 (n=430, 207, 220) | 3.020 Liters | Standard Error 0.0293 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 30 (n=431, 207, 221) | 3.058 Liters | Standard Error 0.0309 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 3 (n=400, 186, 199) | 3.029 Liters | Standard Error 0.0359 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 5 (n=495, 255, 253) | 2.915 Liters | Standard Error 0.0145 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 30 (n=503, 233, 242) | 3.028 Liters | Standard Error 0.0212 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 2 (n=513, 253, 252) | 3.119 Liters | Standard Error 0.0182 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 15 (n=394, 183, 200) | 2.942 Liters | Standard Error 0.0314 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, hour 1 (n=501, 229, 240) | 3.068 Liters | Standard Error 0.0213 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, minute 45 (n=395, 185, 199) | 2.869 Liters | Standard Error 0.0342 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 30 (n=392, 186, 204) | 2.999 Liters | Standard Error 0.0342 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 5 (n=476, 221, 231) | 3.004 Liters | Standard Error 0.0215 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 2 (n=402, 186, 202) | 2.997 Liters | Standard Error 0.0354 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 15 (n=391, 187, 203) | 2.971 Liters | Standard Error 0.033 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 15 (n=479, 222, 234) | 3.024 Liters | Standard Error 0.0234 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 3 (n=510, 248, 252) | 3.129 Liters | Standard Error 0.0193 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 5 (n=386, 185, 199) | 2.925 Liters | Standard Error 0.0328 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, minute 15 (n=388, 183, 198) | 2.866 Liters | Standard Error 0.0349 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 30 (n=405, 189, 201) | 3.016 Liters | Standard Error 0.0345 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 5 (n=454, 217, 227) | 3.047 Liters | Standard Error 0.0262 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 1 (n=404, 190, 201) | 2.992 Liters | Standard Error 0.0339 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 15 (n=405, 188, 201) | 3.001 Liters | Standard Error 0.0336 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 15 (n=459, 220, 225) | 3.050 Liters | Standard Error 0.0257 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 4 (n=504, 239, 250) | 3.076 Liters | Standard Error 0.0192 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 5 (n=398, 189, 199) | 2.982 Liters | Standard Error 0.0344 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 30 (n=460, 220, 226) | 3.079 Liters | Standard Error 0.0265 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 30 (n=507, 252, 254) | 3.004 Liters | Standard Error 0.0177 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, hour 1 (n=412, 195, 215) | 3.014 Liters | Standard Error 0.0336 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 5 (n=453, 212, 230) | 2.991 Liters | Standard Error 0.0253 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 30 (n=402, 189, 202) | 2.923 Liters | Standard Error 0.0325 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 30 (n=410, 196, 215) | 3.002 Liters | Standard Error 0.0333 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 15 (n=448, 205, 222) | 3.003 Liters | Standard Error 0.0252 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 15 (n=481, 243, 239) | 2.926 Liters | Standard Error 0.0178 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 15 (n=407, 191, 214) | 2.983 Liters | Standard Error 0.0327 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 30 (n=455, 212, 226) | 2.985 Liters | Standard Error 0.0251 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 4 (n=397, 184, 199) | 2.984 Liters | Standard Error 0.0359 |
| Glycopyrronium Bromide 50 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 5 (n=408, 194, 212) | 2.967 Liters | Standard Error 0.0321 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 30 (n=405, 189, 201) | 2.734 Liters | Standard Error 0.0419 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 15 (n=502, 255, 254) | 2.719 Liters | Standard Error 0.0199 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 1 (n=511, 256, 254) | 2.732 Liters | Standard Error 0.0214 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 2 (n=513, 253, 252) | 2.762 Liters | Standard Error 0.0227 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 3 (n=510, 248, 252) | 2.811 Liters | Standard Error 0.0243 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 4 (n=504, 239, 250) | 2.767 Liters | Standard Error 0.0244 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 15 (n=481, 243, 239) | 2.745 Liters | Standard Error 0.022 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 45 (n=474, 239, 232) | 2.749 Liters | Standard Error 0.0221 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 5 (n=498, 223, 243) | 2.760 Liters | Standard Error 0.0282 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 15 (n=487, 229, 239) | 2.748 Liters | Standard Error 0.0274 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 30 (n=503, 233, 242) | 2.756 Liters | Standard Error 0.0269 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, hour 1 (n=501, 229, 240) | 2.757 Liters | Standard Error 0.0271 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 5 (n=476, 221, 231) | 2.768 Liters | Standard Error 0.0277 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 15 (n=479, 222, 234) | 2.771 Liters | Standard Error 0.0294 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 30 (n=480, 223, 234) | 2.804 Liters | Standard Error 0.0305 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 5 (n=454, 217, 227) | 2.767 Liters | Standard Error 0.0313 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 15 (n=459, 220, 225) | 2.764 Liters | Standard Error 0.0312 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 30 (n=460, 220, 226) | 2.768 Liters | Standard Error 0.0322 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 5 (n=453, 212, 230) | 2.726 Liters | Standard Error 0.0313 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 15 (n=448, 205, 222) | 2.735 Liters | Standard Error 0.0316 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 30 (n=455, 212, 226) | 2.707 Liters | Standard Error 0.0314 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 1 (n=455, 210, 227) | 2.741 Liters | Standard Error 0.0333 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 2 (n=446, 207, 225) | 2.801 Liters | Standard Error 0.0335 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 4 (n=437, 202, 224) | 2.793 Liters | Standard Error 0.0349 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 45 (n=426, 195, 205) | 2.799 Liters | Standard Error 0.0336 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 5 (n=429, 207, 218) | 2.753 Liters | Standard Error 0.0362 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 15 (n=428, 209, 219) | 2.737 Liters | Standard Error 0.0353 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 5 (n=430, 206, 218) | 2.744 Liters | Standard Error 0.0349 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 30 (n=431, 207, 221) | 2.774 Liters | Standard Error 0.0374 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 5 (421, 202, 213) | 2.733 Liters | Standard Error 0.0352 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 15 (n=414, 200, 207) | 2.713 Liters | Standard Error 0.0363 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 30 (n=424, 206, 213) | 2.715 Liters | Standard Error 0.0342 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 1 (n=425, 206, 212) | 2.721 Liters | Standard Error 0.0352 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 2 (n=420, 203, 208) | 2.777 Liters | Standard Error 0.037 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 3 (n=416, 204, 213) | 2.831 Liters | Standard Error 0.0389 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 4 (n=416, 203, 208) | 2.776 Liters | Standard Error 0.0369 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 15 (n=405, 187, 202) | 2.758 Liters | Standard Error 0.0387 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 45 (n=401, 185, 198) | 2.759 Liters | Standard Error 0.0373 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 5 (n=408, 194, 212) | 2.713 Liters | Standard Error 0.0387 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 15 (n=407, 191, 214) | 2.718 Liters | Standard Error 0.0392 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 30 (n=410, 196, 215) | 2.690 Liters | Standard Error 0.04 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, hour 1 (n=412, 195, 215) | 2.711 Liters | Standard Error 0.04 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 5 (n=398, 189, 199) | 2.727 Liters | Standard Error 0.0415 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 15 (n=405, 188, 201) | 2.713 Liters | Standard Error 0.041 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 5 (n=495, 255, 253) | 2.731 Liters | Standard Error 0.0174 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 5 (n=386, 185, 199) | 2.729 Liters | Standard Error 0.0393 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 15 (n=391, 187, 203) | 2.729 Liters | Standard Error 0.0398 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 30 (n=392, 186, 204) | 2.731 Liters | Standard Error 0.0409 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 15 (n=394, 183, 200) | 2.701 Liters | Standard Error 0.0389 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 30 (n=507, 252, 254) | 2.692 Liters | Standard Error 0.0219 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 3 (n=444, 204, 225) | 2.839 Liters | Standard Error 0.0346 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 15 (n=430, 200, 214) | 2.799 Liters | Standard Error 0.0349 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 30 (n=433, 209, 220) | 2.747 Liters | Standard Error 0.0359 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 15 (n=430, 207, 220) | 2.749 Liters | Standard Error 0.0356 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 5 (n=401, 188, 197) | 2.673 Liters | Standard Error 0.0377 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 30 (n=402, 189, 202) | 2.666 Liters | Standard Error 0.0391 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 1 (n=404, 190, 201) | 2.696 Liters | Standard Error 0.0405 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 2 (n=402, 186, 202) | 2.727 Liters | Standard Error 0.0421 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 3 (n=400, 186, 199) | 2.742 Liters | Standard Error 0.0427 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 4 (n=397, 184, 199) | 2.725 Liters | Standard Error 0.0425 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, minute 15 (n=388, 183, 198) | 2.675 Liters | Standard Error 0.0419 |
| Placebo to Glycopyrronium Bromide | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, minute 45 (n=395, 185, 199) | 2.694 Liters | Standard Error 0.0406 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 5 (n=401, 188, 197) | 2.916 Liters | Standard Error 0.0367 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 15 (n=407, 191, 214) | 2.948 Liters | Standard Error 0.0376 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 5 (n=453, 212, 230) | 2.978 Liters | Standard Error 0.0304 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 15 (n=394, 183, 200) | 2.969 Liters | Standard Error 0.0371 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 30 (n=410, 196, 215) | 2.947 Liters | Standard Error 0.0386 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 30 (n=460, 220, 226) | 3.079 Liters | Standard Error 0.0319 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 4 (n=504, 239, 250) | 3.031 Liters | Standard Error 0.0237 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, hour 1 (n=412, 195, 215) | 2.959 Liters | Standard Error 0.0385 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 15 (n=459, 220, 225) | 3.046 Liters | Standard Error 0.0311 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 15 (n=502, 255, 254) | 2.903 Liters | Standard Error 0.0198 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 5 (n=398, 189, 199) | 2.983 Liters | Standard Error 0.0406 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 9, minute 5 (n=454, 217, 227) | 3.029 Liters | Standard Error 0.0309 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, minute 30 (n=402, 189, 202) | 2.962 Liters | Standard Error 0.0378 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 15 (n=405, 188, 201) | 3.001 Liters | Standard Error 0.0398 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 30 (n=480, 223, 234) | 3.063 Liters | Standard Error 0.0297 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 3 (n=510, 248, 252) | 3.073 Liters | Standard Error 0.0239 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 42, minute 30 (n=405, 189, 201) | 3.021 Liters | Standard Error 0.0408 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 15 (n=479, 222, 234) | 3.024 Liters | Standard Error 0.0286 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, minute 45 (n=395, 185, 199) | 2.868 Liters | Standard Error 0.039 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 5, minute 5 (n=476, 221, 231) | 3.011 Liters | Standard Error 0.027 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 1 (n=404, 190, 201) | 3.011 Liters | Standard Error 0.0393 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 15 (n=391, 187, 203) | 2.962 Liters | Standard Error 0.0384 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, hour 1 (n=501, 229, 240) | 3.023 Liters | Standard Error 0.0267 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 2 (n=513, 253, 252) | 3.033 Liters | Standard Error 0.0226 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 30 (n=503, 233, 242) | 3.018 Liters | Standard Error 0.0265 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 23, minute 15 (n=388, 183, 198) | 2.865 Liters | Standard Error 0.0402 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 15 (n=487, 229, 239) | 3.030 Liters | Standard Error 0.027 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 2 (n=402, 186, 202) | 3.005 Liters | Standard Error 0.0405 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 15 (n=430, 207, 220) | 2.994 Liters | Standard Error 0.0345 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 15, minute 5 (n=498, 223, 243) | 2.980 Liters | Standard Error 0.0272 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 30 (n=431, 207, 221) | 3.028 Liters | Standard Error 0.0362 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 20, minute 5 (n=430, 206, 218) | 2.966 Liters | Standard Error 0.0338 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 45 (n=474, 239, 232) | 2.923 Liters | Standard Error 0.0224 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 5 (421, 202, 213) | 2.945 Liters | Standard Error 0.0345 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 30 (n=433, 209, 220) | 3.036 Liters | Standard Error 0.0353 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 1 (n=511, 256, 254) | 2.975 Liters | Standard Error 0.0213 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 15 (n=414, 200, 207) | 2.959 Liters | Standard Error 0.036 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 15 (n=428, 209, 219) | 3.002 Liters | Standard Error 0.0348 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 3 (n=444, 204, 225) | 3.096 Liters | Standard Error 0.0332 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, minute 30 (n=424, 206, 213) | 2.949 Liters | Standard Error 0.0337 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 16, minute 5 (n=429, 207, 218) | 3.009 Liters | Standard Error 0.0355 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 4 (n=397, 184, 199) | 2.991 Liters | Standard Error 0.041 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 1 (n=425, 206, 212) | 2.997 Liters | Standard Error 0.0346 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 45 (n=426, 195, 205) | 2.946 Liters | Standard Error 0.0332 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 52, hour 3 (n=400, 186, 199) | 3.020 Liters | Standard Error 0.0413 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 2 (n=420, 203, 208) | 3.036 Liters | Standard Error 0.0366 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 23, minute 15 (n=430, 200, 214) | 2.985 Liters | Standard Error 0.0341 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 30 (n=507, 252, 254) | 2.937 Liters | Standard Error 0.0217 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 3 (n=416, 204, 213) | 3.065 Liters | Standard Error 0.0381 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 4 (n=437, 202, 224) | 3.054 Liters | Standard Error 0.0333 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 5 (n=386, 185, 199) | 2.942 Liters | Standard Error 0.0381 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 4 (n=416, 203, 208) | 3.021 Liters | Standard Error 0.0364 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 2 (n=446, 207, 225) | 3.065 Liters | Standard Error 0.0324 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 50, minute 30 (n=392, 186, 204) | 2.998 Liters | Standard Error 0.0394 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 15 (n=405, 187, 202) | 2.901 Liters | Standard Error 0.0379 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, hour 1 (n=455, 210, 227) | 3.048 Liters | Standard Error 0.0322 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, hour 23, minute 15 (n=481, 243, 239) | 2.923 Liters | Standard Error 0.022 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 26, hour 23, minute 45 (n=401, 185, 198) | 2.883 Liters | Standard Error 0.0368 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 30 (n=455, 212, 226) | 2.987 Liters | Standard Error 0.0306 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Day 1, minute 5 (n=495, 255, 253) | 2.856 Liters | Standard Error 0.0174 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 34, minute 5 (n=408, 194, 212) | 2.919 Liters | Standard Error 0.0374 |
| Tiotropium 18 μg | Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 | Week 12, minute 15 (n=448, 205, 222) | 3.004 Liters | Standard Error 0.0307 |
Health-related Quality of Life (QoL) Assessed With the St. George Respiratory Questionnaire (SGRQ) at Week 52
The SGRQ contained 51 patient-rated items divided into three components: Symptoms (respiratory symptoms, their frequency, and severity), Activity (activities that cause or are limited by breathlessness), and Impacts (social functioning and psychological disturbances resulting from airway disease). A total score for the 3 components was calculated and ranged from 0 to 100. Higher values indicate greater impairment of QoL. The analysis included the same covariates as the primary Outcome Measure.
Time frame: Week 52
Population: Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Health-related Quality of Life (QoL) Assessed With the St. George Respiratory Questionnaire (SGRQ) at Week 52 | 40.85 Units on a scale | Standard Error 0.854 |
| Placebo to Glycopyrronium Bromide | Health-related Quality of Life (QoL) Assessed With the St. George Respiratory Questionnaire (SGRQ) at Week 52 | 44.16 Units on a scale | Standard Error 1.04 |
| Tiotropium 18 μg | Health-related Quality of Life (QoL) Assessed With the St. George Respiratory Questionnaire (SGRQ) at Week 52 | 41.32 Units on a scale | Standard Error 1.024 |
Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Per Year During the Study (Baseline to Week 52)
The number of moderate or severe exacerbations of COPD per year during the study was calculated by dividing the total number of exacerbations during the study by the total number of years of treatment. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.
Time frame: Baseline to Week 52
Population: Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glycopyrronium Bromide 50 μg | Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Per Year During the Study (Baseline to Week 52) | 0.54 Exacerbations per treatment year |
| Placebo to Glycopyrronium Bromide | Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Per Year During the Study (Baseline to Week 52) | 0.80 Exacerbations per treatment year |
| Tiotropium 18 μg | Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Per Year During the Study (Baseline to Week 52) | 0.62 Exacerbations per treatment year |
Percentage of Days Able to Perform Usual Daily Activities During the Study (Baseline to Week 52)
A day able to perform usual daily activities was defined as any day where the patient recorded in their electronic diary in the evening that they were not prevented from performing their usual daily activities due to respiratory symptoms during the previous 12 hours. The percentage of days able to perform usual daily activities was calculated as the total number of days able to perform usual daily activities over the 52 week treatment period divided by the total number of days where diary recordings were made.
Time frame: Baseline to Week 52
Population: Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Percentage of Days Able to Perform Usual Daily Activities During the Study (Baseline to Week 52) | 38.02 Percentage of days | Standard Error 1.883 |
| Placebo to Glycopyrronium Bromide | Percentage of Days Able to Perform Usual Daily Activities During the Study (Baseline to Week 52) | 36.18 Percentage of days | Standard Error 2.27 |
| Tiotropium 18 μg | Percentage of Days Able to Perform Usual Daily Activities During the Study (Baseline to Week 52) | 38.09 Percentage of days | Standard Error 2.259 |
Percentage of Days With no Daytime Symptoms During the Study (Baseline to Week 52)
A day with no daytime symptoms was defined as any day where the patient recorded no cough, no wheeze, no production of sputum, no feeling of breathlessness (other than when running), and no puffs of rescue medication during the previous 12 hours in evening entry in the electronic patient diary. The percentage of days with no daytime symptoms was calculated as the total number of days with no daytime symptoms over the 52 week treatment period divided by the total number of days where diary recordings were made.
Time frame: Baseline to Week 52
Population: Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Percentage of Days With no Daytime Symptoms During the Study (Baseline to Week 52) | 6.54 Percentage of days | Standard Error 1.208 |
| Placebo to Glycopyrronium Bromide | Percentage of Days With no Daytime Symptoms During the Study (Baseline to Week 52) | 3.81 Percentage of days | Standard Error 1.431 |
| Tiotropium 18 μg | Percentage of Days With no Daytime Symptoms During the Study (Baseline to Week 52) | 7.14 Percentage of days | Standard Error 1.424 |
Percentage of Nights With no Nighttime Awakenings During the Study (Baseline to Week 52)
A night with no nighttime awakenings was defined as any night where the patient did not wake up due to 1 or more of 6 symptoms (respiratory symptoms, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Symptoms occurring during the previous 12 hours were recorded each morning and evening by the patient in an electronic diary. The percentage of nights with 'no nighttime awakenings' was calculated as the total number of nights with no nighttime awakenings over the 52 week treatment period divided by the total number of nights where diary recordings were made.
Time frame: Baseline to Week 52
Population: Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Percentage of Nights With no Nighttime Awakenings During the Study (Baseline to Week 52) | 57.36 Percentage of nights | Standard Error 1.842 |
| Placebo to Glycopyrronium Bromide | Percentage of Nights With no Nighttime Awakenings During the Study (Baseline to Week 52) | 52.15 Percentage of nights | Standard Error 2.239 |
| Tiotropium 18 μg | Percentage of Nights With no Nighttime Awakenings During the Study (Baseline to Week 52) | 55.47 Percentage of nights | Standard Error 2.23 |
Percentage of Patients Who Experienced a Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)
A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.
Time frame: Baseline to Week 52
Population: Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glycopyrronium Bromide 50 μg | Percentage of Patients Who Experienced a Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52) | 32.8 Percentage of participants |
| Placebo to Glycopyrronium Bromide | Percentage of Patients Who Experienced a Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52) | 40.2 Percentage of participants |
| Tiotropium 18 μg | Percentage of Patients Who Experienced a Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52) | 30.1 Percentage of participants |
Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)
Time to first moderate or severe COPD exacerbation was calculated as the number of days from baseline to the day on which the patient experienced the first moderate or severe COPD exacerbation. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.
Time frame: Baseline to Week 52 (patients with no moderate or severe exacerbations who completed the study were censored at the final visit date, which may have exceeded 52 weeks)
Population: Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Glycopyrronium Bromide 50 μg | Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52) | 363.0 Days |
| Placebo to Glycopyrronium Bromide | Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52) | 231.0 Days |
| Tiotropium 18 μg | Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52) | 364.0 Days |
Transition Dyspnea Index (TDI) at Week 26
The TDI measured changes in dyspnea from baseline during treatment and included 3 domains: Functional impairment (activities of daily living), magnitude of task (intensity of activity), and magnitude of effort (difficulty breathing). Each domain was rated from -3 to 3 (major deterioration-major improvement). The total score ranged from -9 to 9; minus scores indicate deterioration. The analysis included the same covariates as the primary Outcome Measure.
Time frame: Week 26
Population: Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Transition Dyspnea Index (TDI) at Week 26 | 2.13 Units on a scale | Standard Error 0.24 |
| Placebo to Glycopyrronium Bromide | Transition Dyspnea Index (TDI) at Week 26 | 1.32 Units on a scale | Standard Error 0.289 |
| Tiotropium 18 μg | Transition Dyspnea Index (TDI) at Week 26 | 2.26 Units on a scale | Standard Error 0.281 |
Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included the same covariates as the primary Outcome Measure.
Time frame: Day 1, Week 26, and Week 52
Population: Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52 | Week 52 (n=416, 196, 210) | 1.412 Liters | Standard Error 0.0157 |
| Glycopyrronium Bromide 50 μg | Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52 | Week 26 (n=451, 219, 233) | 1.458 Liters | Standard Error 0.0161 |
| Glycopyrronium Bromide 50 μg | Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52 | Day 1 | 1.478 Liters | Standard Error 0.0088 |
| Placebo to Glycopyrronium Bromide | Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52 | Week 52 (n=416, 196, 210) | 1.303 Liters | Standard Error 0.0198 |
| Placebo to Glycopyrronium Bromide | Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52 | Week 26 (n=451, 219, 233) | 1.324 Liters | Standard Error 0.0196 |
| Placebo to Glycopyrronium Bromide | Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52 | Day 1 | 1.388 Liters | Standard Error 0.0109 |
| Tiotropium 18 μg | Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52 | Week 26 (n=451, 219, 233) | 1.408 Liters | Standard Error 0.0191 |
| Tiotropium 18 μg | Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52 | Day 1 | 1.471 Liters | Standard Error 0.0109 |
| Tiotropium 18 μg | Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52 | Week 52 (n=416, 196, 210) | 1.392 Liters | Standard Error 0.0191 |
Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52
Trough FVC is defined as the average of the post-dose 23 h 15 min and the 23 h 45 min FVC values. Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told At the end of the next normal breath out, take a deep breath all the way in; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure.
Time frame: Day 1, Week 12, Week 26, and Week 52
Population: Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Glycopyrronium Bromide 50 μg | Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52 | Day 1 | 2.936 Liters | Standard Error 0.0165 |
| Glycopyrronium Bromide 50 μg | Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52 | Week 12 (n=442, 204, 217) | 2.985 Liters | Standard Error 0.0265 |
| Glycopyrronium Bromide 50 μg | Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52 | Week 52 (n=395, 186, 201) | 2.866 Liters | Standard Error 0.0335 |
| Glycopyrronium Bromide 50 μg | Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52 | Week 26 (n=418, 196, 208) | 2.962 Liters | Standard Error 0.0299 |
| Placebo to Glycopyrronium Bromide | Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52 | Week 12 (n=442, 204, 217) | 2.802 Liters | Standard Error 0.0329 |
| Placebo to Glycopyrronium Bromide | Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52 | Week 26 (n=418, 196, 208) | 2.758 Liters | Standard Error 0.0361 |
| Placebo to Glycopyrronium Bromide | Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52 | Day 1 | 2.757 Liters | Standard Error 0.0205 |
| Placebo to Glycopyrronium Bromide | Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52 | Week 52 (n=395, 186, 201) | 2.687 Liters | Standard Error 0.0399 |
| Tiotropium 18 μg | Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52 | Week 52 (n=395, 186, 201) | 2.866 Liters | Standard Error 0.0383 |
| Tiotropium 18 μg | Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52 | Week 12 (n=442, 204, 217) | 2.970 Liters | Standard Error 0.0323 |
| Tiotropium 18 μg | Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52 | Day 1 | 2.930 Liters | Standard Error 0.0206 |
| Tiotropium 18 μg | Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52 | Week 26 (n=418, 196, 208) | 2.892 Liters | Standard Error 0.0355 |