Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions. 2. All patients must have a diagnosis of chronic obstructive pulmonary disease (P95 4381) and must meet the following spirometric criteria: Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 (post-bronchodilator, 30 minutes post salbutamol/albuterol) \<80% of predicted normal and FEV1 less than or equal to 70% of FVC at the PFTs at Visit 1 (screening). 3. Male or female patients 40 years of age or older. 4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded. 5. Patients must be able to perform technically acceptable pulmonary function tests and electronic PEFR measurements, and must be able to maintain records (Patient Daily Diary) during the study period as required in the protocol. 6. Patients must be able to inhale medication in a competent manner from the Respimat® inhaler (Appendix I)
Exclusion criteria
1. Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient ability to participate in the study. 2. Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1. 3. Patients with a recent history (one year or less) of myocardial infarction. 4. Patients with any unstable or life-threatening cardiac arrhythmia. 5. Patients who have been hospitalized for heart failure within the past 3 years. 6. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed. 7. Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction as defined in
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks | 40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 24. | Trough Forced expiratory volume in one second (FEV1) response was defined as the change from baseline in trough FEV1. Trough FEV1 was defined as the mean of the two FEV1 measurements recorded at the pre-dose measurements (40 and 15 minutes before the drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler). Baseline FEV1 was pre-treatment FEV1 values measured at Day 1 of treatment period (baseline) prior to administration of the first dose of study medication, which was the mean of the measurements recorded from the pulmonary function tests taken at 40 and 15 minutes prior to drug administration at Day 1 of treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | 40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 1, 2, 4, 8, 12, 18, and 24. | Trough forced vital capacity (FVC) response was defined as the change from baseline in trough FVC. Trough FVC was defined as the mean of the two FVC measurements recorded at the pre-dose measurements (40 and 15 minutes before drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler), which were obtained through spirometry at the same time points as for forced expiratory volume in one second. Baseline FVC was the mean of the two measurements of FVC taken at 40 and 15 minutes before drug administration at Day 1 of treatment period. |
| Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | 40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24. | Forced expiratory volume in one second (FEV1) area under the curve from 0 to 3 hours (AUC0-3h) response after 0, 4, 12 and 24 weeks are reported. The FEV1 AUC0-3h response is the area under the curve from 0 to 3 hours post drug administration for change from baseline values of FEV1. The area under the curve (AUC) is calculated as the area under the curve from 0 to 3 hours at weeks 0, 4, 12 and 24 using the trapezoidal rule and using planned time, divided by the full duration (3 hours) to report in litres. The mean of the pre-dose values (at 40 minutes and 15 minutes before dosing) are used with a time value of zero for calculating the AUC values starting at zero. The baseline FEV1 is the mean of the two measurements taken at 40 and 15 minutes before drug administration at Day 1 of treatment period. |
| Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | 40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24. | Forced vital capacity (FVC) area under the curve from 0 to 3 hours (AUC0-3h) response after 0, 4, 12 and 24 weeks are reported. The FVC AUC0-3h response is the area under the curve from 0 to 3 hours post drug administration for change from baseline values of FVC. The area under the curve (AUC) is calculated as the area under the curve from 0 to 3 hours at weeks 0, 4, 12 and 24 using the trapezoidal rule and using planned time, divided by the full duration (3 hours) to report in litres. The mean of the pre-dose values (at 40 minutes and 15 minutes before dosing) are used with a time value of zero for calculating the AUC values starting at zero. The baseline FVC is the mean of the two measurements taken at 40 and 15 minutes before drug administration at Day 1 of treatment period. |
| Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | 40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24. | Forced expiratory volume in one second (FEV1) peak response after 0, 4, 12, and 24 weeks were reported. Peak FEV1 response was the maximum change from baseline for the post-dose measurements of FEV1. Baseline FEV1 is the mean of the two measurements taken at 40 and 15 minutes before drug administration. |
| Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | 40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24. | Forced Vital Capacity (FVC) peak response after 0, 4, 12, and 24 weeks were reported. Peak FVC response was the maximum change from baseline for the post-dose measurements of FVC. Baseline FVC is the mean of the two measurements taken at 40 and 15 minutes before drug administration. |
| Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | 15 minutes (min), 30 min, 1 hour (h), 2 h, 3 h after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24. At 0 min (at drug administration) at Week 4, 12, and 24. | Individual Forced expiratory volume in one second (FEV1) values measured at each time points at Week 0, 4, 12, and 24 were reported. |
| Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | 15 minutes (min), 30 min, 1 hour (h), 2 h, 3 h after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24. At 0 min (at drug administration) at Week 4, 12, and 24. | Individual Forced Vital Capacity (FVC) values measured at each time point at Week 0, 4, 12, and 24 were reported. |
| Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5 | 40 minutes (min) and 15 min before drug administration at Day 1 (baseline) and Day 3 and 5 of treatment period. | Trough Forced expiratory volume in one second (FEV1) response on Day 3 and 5 are reported, for which the FEV1 response is the change from baseline in trough FEV1. Trough FEV1 for respective day (Day 3 or Day 5)was defined as the mean of the two FEV1 measurements recorded at the pre-dose measurements (40 and 15 minutes before the drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler) at that day. Baseline FEV1 was pre-treatment FEV1 values measured at Day 1 of treatment period (baseline) prior to administration of the first dose of study medication, which was the mean of the measurements recorded from the pulmonary function tests taken at 40 and 15 minutes prior to drug administration at Day 1 of treatment period. |
| Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | 3 minutes (min) and 10 after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24. | Forced expiratory volume in one second (FEV1) values at 3 minutes and 10 minutes following drug administration at Week 0, 4, 12, and 24 are reported. |
| Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | 3 minutes (min) and 10 min after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24. | Forced Vital Capacity (FVC) values at 3 minutes and 10 minutes following drug administration at Week 0, 4, 12, and 24 are reported. |
| Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Assessed before drug administration per day during 24 weeks with weekly mean values reporting. | The patient recorded twice daily peak flow measurements with an electronic peak flow meter throughout the entire evaluation period. Morning measurements were performed immediately upon arising after the patient had cleared out mucus, prior to administration of trial and/or rescue medication. The evening measurements were performed at bedtime. The weekly mean morning peak expiratory flow rate (PEFR) is reported. |
| Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Assessed at bed time per day during 24 weeks with weekly mean values reporting. | The patient recorded twice daily peak flow measurements with an electronic peak flow meter throughout the entire evaluation period. Morning measurements were performed immediately upon arising after the patient had cleared out mucus, prior to administration of trial and/or rescue medication. The evening measurements were performed at bedtime. The weekly mean of evening peak expiratory flow rate (PEFR) is reported. |
| Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Assessed once per day during 24 weeks with weekly mean values reporting. | The patient recorded the number of occasions salbutamol (albuterol) Metered Dose Inhaler (MDI) was used each day and night during the entire evaluation period. The weekly mean number of occasions of rescue therapy used per day (PRN salbutamol \[albuterol\]) is reported. |
| Physician's Global Evaluation | At Week 0, 4, 12, and 24. | Physicians make a global evaluation reflecting the physician's global opinion of the overall clinical condition of the patient as poor (score 1 or 2), fair (score 3 or 4), good (score 5 or 6), or excellent (score 7 or 8). These assessments are made prior to pulmonary function testing and are summarized on pulmonary function test days. This evaluation was based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, and other relevant clinical observations. The score ranges from 1 to 8 with higher score indicating better overall clinical condition. |
| Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | 40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 1, 2, 4, 8, 12 and 18. | Trough Forced expiratory volume in one second (FEV1) response was defined as the change from baseline in trough FEV1. Trough FEV1 was defined as the mean of the two FEV1 measurements recorded at the pre-dose measurements (40 and 15 minutes before the drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler). Baseline FEV1 was pre-treatment FEV1 values measured at Day 1 of treatment period (baseline) prior to administration of the first dose of study medication, which was the mean of the measurements recorded from the pulmonary function tests taken at 40 and 15 minutes prior to drug administration at Day 1 of treatment period. |
| Transition Dyspnea Index - Magnitude of Task Domain Score | At week 0 (baseline), 4, 12 and 24 | The transitional dyspnea index (TDI) evaluates the patient's condition related to breathlessness. The TDI includes three domains: functional impairment, magnitude of task, and magnitude of effort. The TDI domain score of magnitude of task is reported, which domain score ranges from -3 (major deterioration from baseline status; the worst score) to 3 (major improvement from baseline status; the best score). |
| Transition Dyspnea Index - Magnitude of Effort Domain Score | At Week 0 (baseline), 4, 12 and 24 | The transitional dyspnea index (TDI) evaluates the patient's condition related to breathlessness. The TDI includes three domains: functional impairment, magnitude of task, and magnitude of effort. The TDI domain score of magnitude of effort is reported, which sub-score ranges from -3 (severe decrease in effort from baseline to avoid shortness of breath. Activities now take 50-100% longer to complete than required at baseline; the worst score) to 3 (Able to do things with much greater effort than previously with few pauses. Activities may be performed 50- 100% more rapidly than at baseline; the best score). |
| St. George's Respiratory Questionnaire (SGRQ) Total Score | At Week 0, 4, 12, and 24. | The St. George's Respiratory Questionnaire (SGRQ) is a well-established, self-completed tool measuring health-related quality of life in patients with diseases of airways obstruction on three aspects of symptoms, activity, and impacts. The total SGRQ score is reported, which ranges from 0 (the best score) to 100 (the worst score) with smaller score value indicating less limitations due to breathlessness and better quality of life. |
| 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | At baseline (Week 0, Day 1 of treatment period). | The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function (10 questions), role physical (4 questions), Bodily pain (2 questions), General physical health (5 questions), Vitality (4 questions), Social functioning (2 questions), role emotional (3 questions), and General mental health (5 questions). Each domain score is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the score value, the better the health condition. |
| 36-item-health Survey (SF-36) - Physical Function Domain Score | At Week 4, 12, and 24. | The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of physical function (based on 10 questions) is reported, which is the weighted sum of the questions in corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the physical function. |
| 36-item-health Survey (SF-36) - Role Physical Domain Score | At Week 4, 12, and 24. | The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of role limitations due to physical health problems (based on 4 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the less limitations in roles due to physical health problems. |
| 36-item-health Survey (SF-36) - Bodily Pain Domain Score | At Week 4, 12, and 24. | The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of bodily pain (based on 2 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the less severer the bodily pain. |
| 36-item-health Survey (SF-36) - General Physical Health Domain Score | At Week 4, 12, and 24. | The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of general physical health (based on 5 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the physical health in general. |
| 36-item-health Survey (SF-36) - Vitality Domain Score | At Week 4, 12, and 24. | The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of vitality (based on 4 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the more vitality and less fatigue one has. |
| 36-item-health Survey (SF-36) - Social Functioning Domain Score | At Week 4, 12, and 24. | The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of Social functioning (based on 2 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the social functioning. |
| 36-item-health Survey (SF-36) - Role Emotional Domain Score | At Week 4, 12, and 24. | The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of role emotional (based on 4 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the less limitation in roles due to emotional problems. |
| 36-item-health Survey (SF-36) - General Mental Health Domain Score | At Week 4, 12, and 24. | The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of general mental health (based on 5 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the mental health in general. |
| Number of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | From first does until 30 days after the end of treatment, up to 205 days. | Number of patients with at least one Chronic Obstructive Pulmonary Disease (COPD) exacerbation is reported. Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation is reported. A Chronic Obstructive Pulmonary Disease (COPD) exacerbation is defined as a complex of lower respiratory events / symptoms (increase or new onset) related to the underlying COPD, with a duration of three days or more, requiring a change in treatment, where a complex of lower respiratory events / symptoms means at least two of the following: Shortness of breath, Sputum production (volume), Occurrence of purulent sputum, Cough, Wheezing, Chest tightness. |
| Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | From first does until 30 days after the end of treatment, up to 205 days. | Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation is reported. A Chronic Obstructive Pulmonary Disease (COPD) exacerbation is defined as a complex of lower respiratory events / symptoms (increase or new onset) related to the underlying COPD, with a duration of three days or more, requiring a change in treatment, where a complex of lower respiratory events / symptoms means at least two of the following: Shortness of breath, Sputum production (volume), Occurrence of purulent sputum, Cough, Wheezing, Chest tightness. |
| Transition Dyspnea Index - Functional Impairment Domain Score | At Week 0 (baseline), 4, 12 and 24. | The transitional dyspnea index (TDI) evaluates the patient's condition related to breathlessness. The TDI includes three domains: functional impairment, magnitude of task, and magnitude of effort. The TDI domain score of functional impairment is reported, which domain score ranges from -3 (major deterioration in the ability of working and doing activities due to shortness of breath; the worst score) to 3 (major improvement in the ability of working and doing activities; mild restriction on full activities due to the improvement of shortness of breath; the best score). |
Countries
Canada, Germany, Hungary, Mexico, Poland, Russia, South Korea, Spain, Taiwan, United States
Participant flow
Recruitment details
A multinational, randomized, double-blind, placebo-and active-controlled, parallel group efficacy and safety comparison of BEA 2180 to tiotropium and placebo delivered by the Respimat® inhaler in patients with chronic obstructive pulmonary disease (COPD).
Pre-assignment details
All subjects were screened for eligibility to participate in trial. Subjects visited specialist site to ensure that they met all implemented inclusion criteria. Subjects meeting the exclusion criteria were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Oral inhalation of solution of Placebo matching BEA 2180 BR was administered once daily via Respimat® inhaler for 24 weeks. | 429 |
| BEA 2180 BR 50 Microgram (mcg) 2 oral inhalations of solution of 25 micrograms (mcg) of BEA 2180 BR (total: 50 mcg) were administered via Respimat® inhaler once daily for 24 weeks. | 419 |
| BEA 2180 BR 100 Microgram (mcg) 2 oral inhalations of solution of 50 micrograms (mcg) of BEA 2180 BR (total: 100 mcg) were administered via Respimat® inhaler once daily for 24 weeks. | 415 |
| BEA 2180 BR 200 Microgram (mcg) 2 oral inhalations of solution of 100 micrograms (mcg) of BEA 2180 BR (total: 200 mcg) were administered via Respimat® inhaler once daily for 24 weeks. | 390 |
| Tiotropium Bromide 5 Microgram (mcg) 2 inhalation of solution of 2.5 micrograms (mcg) of Tiotropium Bromide (total: 5 mcg) were administered orally via Respimat® inhaler once daily for 24 weeks. | 427 |
| Total | 2,080 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 32 | 13 | 18 | 29 | 18 |
| Overall Study | Lack of Efficacy | 7 | 2 | 1 | 3 | 3 |
| Overall Study | Lost to Follow-up | 2 | 0 | 4 | 1 | 3 |
| Overall Study | Other reasons than listing | 6 | 7 | 14 | 11 | 5 |
| Overall Study | Protocol Violation | 1 | 2 | 3 | 3 | 2 |
| Overall Study | Refused continue medication | 16 | 0 | 3 | 3 | 6 |
Baseline characteristics
| Characteristic | Placebo | Total | Tiotropium Bromide 5 Microgram (mcg) | BEA 2180 BR 200 Microgram (mcg) | BEA 2180 BR 100 Microgram (mcg) | BEA 2180 BR 50 Microgram (mcg) |
|---|---|---|---|---|---|---|
| Age, Continuous | 64.41 Year STANDARD_DEVIATION 8.57 | 64.16 Year STANDARD_DEVIATION 8.79 | 63.91 Year STANDARD_DEVIATION 8.74 | 63.89 Year STANDARD_DEVIATION 8.88 | 64.60 Year STANDARD_DEVIATION 9.11 | 63.98 Year STANDARD_DEVIATION 8.66 |
| Forced expiratory volume in one second (FEV1) | 1.18 liter STANDARD_DEVIATION 0.46 | 1.18 liter STANDARD_DEVIATION 0.47 | 1.20 liter STANDARD_DEVIATION 0.47 | 1.19 liter STANDARD_DEVIATION 0.49 | 1.18 liter STANDARD_DEVIATION 0.48 | 1.18 liter STANDARD_DEVIATION 0.46 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 14 Participants | 0 Participants | 4 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 35 Participants | 168 Participants | 34 Participants | 31 Participants | 34 Participants | 34 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 58 Participants | 11 Participants | 15 Participants | 12 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 384 Participants | 1840 Participants | 382 Participants | 340 Participants | 363 Participants | 371 Participants |
| Sex: Female, Male Female | 155 Participants | 739 Participants | 146 Participants | 140 Participants | 146 Participants | 152 Participants |
| Sex: Female, Male Male | 274 Participants | 1341 Participants | 281 Participants | 250 Participants | 269 Participants | 267 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 429 | 3 / 419 | 3 / 415 | 7 / 390 | 2 / 427 |
| other Total, other adverse events | 132 / 429 | 106 / 419 | 115 / 415 | 89 / 390 | 107 / 427 |
| serious Total, serious adverse events | 43 / 429 | 37 / 419 | 33 / 415 | 36 / 390 | 35 / 427 |
Outcome results
Primary
Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks
Trough Forced expiratory volume in one second (FEV1) response was defined as the change from baseline in trough FEV1. Trough FEV1 was defined as the mean of the two FEV1 measurements recorded at the pre-dose measurements (40 and 15 minutes before the drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler). Baseline FEV1 was pre-treatment FEV1 values measured at Day 1 of treatment period (baseline) prior to administration of the first dose of study medication, which was the mean of the measurements recorded from the pulmonary function tests taken at 40 and 15 minutes prior to drug administration at Day 1 of treatment period.
Time frame: 40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks | -0.034 litre | Standard Error 0.01 |
| BEA 2180 BR 50 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks | 0.044 litre | Standard Error 0.01 |
| BEA 2180 BR 100 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks | 0.066 litre | Standard Error 0.011 |
| BEA 2180 BR 200 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks | 0.087 litre | Standard Error 0.011 |
| Tiotropium Bromide 5 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks | 0.092 litre | Standard Error 0.01 |
Secondary
36-item-health Survey (SF-36) 8 Domain Scores at Baseline
The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function (10 questions), role physical (4 questions), Bodily pain (2 questions), General physical health (5 questions), Vitality (4 questions), Social functioning (2 questions), role emotional (3 questions), and General mental health (5 questions). Each domain score is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the score value, the better the health condition.
Time frame: At baseline (Week 0, Day 1 of treatment period).
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement. Only patients with non-missing outcomes are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Physical function | 50.2 Score on a scale | Standard Deviation 24.5 |
| Placebo | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Role physical | 53.9 Score on a scale | Standard Deviation 27.5 |
| Placebo | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Bodily pain | 68.9 Score on a scale | Standard Deviation 26.6 |
| Placebo | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | General physical health | 48.5 Score on a scale | Standard Deviation 18.5 |
| Placebo | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Vitality | 53.9 Score on a scale | Standard Deviation 20.3 |
| Placebo | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Social functioning | 75.3 Score on a scale | Standard Deviation 24 |
| Placebo | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Role emotional | 70.0 Score on a scale | Standard Deviation 28.9 |
| Placebo | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | General mental health | 72.0 Score on a scale | Standard Deviation 19.2 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Bodily pain | 68.6 Score on a scale | Standard Deviation 25.5 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Social functioning | 76.2 Score on a scale | Standard Deviation 22.8 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Physical function | 51.4 Score on a scale | Standard Deviation 25.1 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | General physical health | 49.2 Score on a scale | Standard Deviation 18 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Role physical | 55.9 Score on a scale | Standard Deviation 27.5 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | General mental health | 70.4 Score on a scale | Standard Deviation 19.4 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Vitality | 53.6 Score on a scale | Standard Deviation 20.1 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Role emotional | 70.8 Score on a scale | Standard Deviation 28.1 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Role emotional | 69.3 Score on a scale | Standard Deviation 27.6 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | General mental health | 71.2 Score on a scale | Standard Deviation 19.3 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | General physical health | 48.0 Score on a scale | Standard Deviation 18.7 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Social functioning | 75.2 Score on a scale | Standard Deviation 24.4 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Bodily pain | 66.7 Score on a scale | Standard Deviation 26.7 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Role physical | 53.3 Score on a scale | Standard Deviation 26.7 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Physical function | 51.9 Score on a scale | Standard Deviation 24.2 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Vitality | 53.4 Score on a scale | Standard Deviation 21.1 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Role physical | 53.9 Score on a scale | Standard Deviation 27.7 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Bodily pain | 67.1 Score on a scale | Standard Deviation 26.8 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | General physical health | 48.5 Score on a scale | Standard Deviation 19.2 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Vitality | 52.1 Score on a scale | Standard Deviation 20.3 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Social functioning | 74.3 Score on a scale | Standard Deviation 23.9 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | General mental health | 68.5 Score on a scale | Standard Deviation 20 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Physical function | 49.1 Score on a scale | Standard Deviation 24.7 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Role emotional | 67.8 Score on a scale | Standard Deviation 29.6 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | General physical health | 47.1 Score on a scale | Standard Deviation 18.4 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | General mental health | 68.5 Score on a scale | Standard Deviation 19.2 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Bodily pain | 65.9 Score on a scale | Standard Deviation 26.8 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Role emotional | 68.5 Score on a scale | Standard Deviation 27.8 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Physical function | 51.1 Score on a scale | Standard Deviation 22.9 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Social functioning | 74.2 Score on a scale | Standard Deviation 23 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Role physical | 54.9 Score on a scale | Standard Deviation 27.1 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) 8 Domain Scores at Baseline | Vitality | 51.8 Score on a scale | Standard Deviation 20.3 |
Secondary
36-item-health Survey (SF-36) - Bodily Pain Domain Score
The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of bodily pain (based on 2 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the less severer the bodily pain.
Time frame: At Week 4, 12, and 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement. Only patients with non-missing outcomes are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 36-item-health Survey (SF-36) - Bodily Pain Domain Score | Week 4 | 66.828 Score on a scale | Standard Error 1.024 |
| Placebo | 36-item-health Survey (SF-36) - Bodily Pain Domain Score | Week 24 | 64.964 Score on a scale | Standard Error 1.162 |
| Placebo | 36-item-health Survey (SF-36) - Bodily Pain Domain Score | Week 12 | 66.749 Score on a scale | Standard Error 1.124 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Bodily Pain Domain Score | Week 12 | 66.698 Score on a scale | Standard Error 1.12 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Bodily Pain Domain Score | Week 4 | 68.184 Score on a scale | Standard Error 1.02 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Bodily Pain Domain Score | Week 24 | 66.610 Score on a scale | Standard Error 1.158 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Bodily Pain Domain Score | Week 12 | 70.316 Score on a scale | Standard Error 1.132 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Bodily Pain Domain Score | Week 4 | 70.738 Score on a scale | Standard Error 1.031 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Bodily Pain Domain Score | Week 24 | 68.279 Score on a scale | Standard Error 1.171 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Bodily Pain Domain Score | Week 4 | 66.439 Score on a scale | Standard Error 1.063 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Bodily Pain Domain Score | Week 24 | 66.887 Score on a scale | Standard Error 1.205 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Bodily Pain Domain Score | Week 12 | 67.815 Score on a scale | Standard Error 1.167 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Bodily Pain Domain Score | Week 12 | 70.300 Score on a scale | Standard Error 1.115 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Bodily Pain Domain Score | Week 4 | 70.512 Score on a scale | Standard Error 1.015 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Bodily Pain Domain Score | Week 24 | 69.995 Score on a scale | Standard Error 1.153 |
Secondary
36-item-health Survey (SF-36) - General Mental Health Domain Score
The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of general mental health (based on 5 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the mental health in general.
Time frame: At Week 4, 12, and 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement. Only patients with non-missing outcomes are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 36-item-health Survey (SF-36) - General Mental Health Domain Score | Week 4 | 69.585 Score on a scale | Standard Error 0.649 |
| Placebo | 36-item-health Survey (SF-36) - General Mental Health Domain Score | Week 24 | 68.144 Score on a scale | Standard Error 0.758 |
| Placebo | 36-item-health Survey (SF-36) - General Mental Health Domain Score | Week 12 | 69.201 Score on a scale | Standard Error 0.743 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - General Mental Health Domain Score | Week 12 | 70.320 Score on a scale | Standard Error 0.74 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - General Mental Health Domain Score | Week 4 | 71.056 Score on a scale | Standard Error 0.646 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - General Mental Health Domain Score | Week 24 | 70.012 Score on a scale | Standard Error 0.755 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - General Mental Health Domain Score | Week 12 | 70.362 Score on a scale | Standard Error 0.748 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - General Mental Health Domain Score | Week 4 | 70.927 Score on a scale | Standard Error 0.653 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - General Mental Health Domain Score | Week 24 | 69.868 Score on a scale | Standard Error 0.764 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - General Mental Health Domain Score | Week 4 | 71.038 Score on a scale | Standard Error 0.674 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - General Mental Health Domain Score | Week 24 | 70.904 Score on a scale | Standard Error 0.788 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - General Mental Health Domain Score | Week 12 | 71.466 Score on a scale | Standard Error 0.772 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - General Mental Health Domain Score | Week 12 | 71.048 Score on a scale | Standard Error 0.737 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - General Mental Health Domain Score | Week 4 | 71.281 Score on a scale | Standard Error 0.643 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - General Mental Health Domain Score | Week 24 | 69.286 Score on a scale | Standard Error 0.752 |
Secondary
36-item-health Survey (SF-36) - General Physical Health Domain Score
The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of general physical health (based on 5 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the physical health in general.
Time frame: At Week 4, 12, and 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement. Only patients with non-missing outcomes are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 36-item-health Survey (SF-36) - General Physical Health Domain Score | Week 4 | 47.187 Score on a scale | Standard Error 0.63 |
| Placebo | 36-item-health Survey (SF-36) - General Physical Health Domain Score | Week 24 | 45.913 Score on a scale | Standard Error 0.718 |
| Placebo | 36-item-health Survey (SF-36) - General Physical Health Domain Score | Week 12 | 46.709 Score on a scale | Standard Error 0.679 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - General Physical Health Domain Score | Week 12 | 48.402 Score on a scale | Standard Error 0.677 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - General Physical Health Domain Score | Week 4 | 48.725 Score on a scale | Standard Error 0.628 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - General Physical Health Domain Score | Week 24 | 48.520 Score on a scale | Standard Error 0.716 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - General Physical Health Domain Score | Week 12 | 50.057 Score on a scale | Standard Error 0.685 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - General Physical Health Domain Score | Week 4 | 50.929 Score on a scale | Standard Error 0.635 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - General Physical Health Domain Score | Week 24 | 50.156 Score on a scale | Standard Error 0.724 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - General Physical Health Domain Score | Week 4 | 49.476 Score on a scale | Standard Error 0.656 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - General Physical Health Domain Score | Week 24 | 49.816 Score on a scale | Standard Error 0.746 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - General Physical Health Domain Score | Week 12 | 49.482 Score on a scale | Standard Error 0.706 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - General Physical Health Domain Score | Week 12 | 50.847 Score on a scale | Standard Error 0.674 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - General Physical Health Domain Score | Week 4 | 50.609 Score on a scale | Standard Error 0.625 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - General Physical Health Domain Score | Week 24 | 49.477 Score on a scale | Standard Error 0.712 |
Secondary
36-item-health Survey (SF-36) - Physical Function Domain Score
The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of physical function (based on 10 questions) is reported, which is the weighted sum of the questions in corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the physical function.
Time frame: At Week 4, 12, and 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement. Only patients with non-missing outcomes are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 36-item-health Survey (SF-36) - Physical Function Domain Score | Week 4 | 50.201 Score on a scale | Standard Error 0.726 |
| Placebo | 36-item-health Survey (SF-36) - Physical Function Domain Score | Week 24 | 50.624 Score on a scale | Standard Error 0.854 |
| Placebo | 36-item-health Survey (SF-36) - Physical Function Domain Score | Week 12 | 50.541 Score on a scale | Standard Error 0.806 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Physical Function Domain Score | Week 12 | 52.561 Score on a scale | Standard Error 0.804 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Physical Function Domain Score | Week 4 | 51.831 Score on a scale | Standard Error 0.724 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Physical Function Domain Score | Week 24 | 52.702 Score on a scale | Standard Error 0.851 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Physical Function Domain Score | Week 12 | 52.099 Score on a scale | Standard Error 0.813 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Physical Function Domain Score | Week 4 | 52.812 Score on a scale | Standard Error 0.732 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Physical Function Domain Score | Week 24 | 51.631 Score on a scale | Standard Error 0.861 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Physical Function Domain Score | Week 4 | 52.961 Score on a scale | Standard Error 0.754 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Physical Function Domain Score | Week 24 | 52.256 Score on a scale | Standard Error 0.887 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Physical Function Domain Score | Week 12 | 53.716 Score on a scale | Standard Error 0.838 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Physical Function Domain Score | Week 12 | 53.935 Score on a scale | Standard Error 0.8 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Physical Function Domain Score | Week 4 | 53.052 Score on a scale | Standard Error 0.72 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Physical Function Domain Score | Week 24 | 54.191 Score on a scale | Standard Error 0.847 |
Secondary
36-item-health Survey (SF-36) - Role Emotional Domain Score
The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of role emotional (based on 4 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the less limitation in roles due to emotional problems.
Time frame: At Week 4, 12, and 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement. Only patients with non-missing outcomes are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 36-item-health Survey (SF-36) - Role Emotional Domain Score | Week 4 | 69.365 Score on a scale | Standard Error 1.073 |
| Placebo | 36-item-health Survey (SF-36) - Role Emotional Domain Score | Week 24 | 66.168 Score on a scale | Standard Error 1.184 |
| Placebo | 36-item-health Survey (SF-36) - Role Emotional Domain Score | Week 12 | 67.399 Score on a scale | Standard Error 1.108 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Emotional Domain Score | Week 12 | 70.213 Score on a scale | Standard Error 1.104 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Emotional Domain Score | Week 4 | 70.509 Score on a scale | Standard Error 1.07 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Emotional Domain Score | Week 24 | 70.884 Score on a scale | Standard Error 1.18 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Emotional Domain Score | Week 12 | 71.035 Score on a scale | Standard Error 1.116 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Emotional Domain Score | Week 4 | 70.473 Score on a scale | Standard Error 1.081 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Emotional Domain Score | Week 24 | 68.756 Score on a scale | Standard Error 1.193 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Emotional Domain Score | Week 4 | 71.646 Score on a scale | Standard Error 1.115 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Emotional Domain Score | Week 24 | 70.454 Score on a scale | Standard Error 1.228 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Emotional Domain Score | Week 12 | 69.505 Score on a scale | Standard Error 1.15 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Emotional Domain Score | Week 12 | 70.081 Score on a scale | Standard Error 1.099 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Emotional Domain Score | Week 4 | 71.313 Score on a scale | Standard Error 1.065 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Emotional Domain Score | Week 24 | 69.259 Score on a scale | Standard Error 1.174 |
Secondary
36-item-health Survey (SF-36) - Role Physical Domain Score
The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of role limitations due to physical health problems (based on 4 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the less limitations in roles due to physical health problems.
Time frame: At Week 4, 12, and 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement. Only patients with non-missing outcomes are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 36-item-health Survey (SF-36) - Role Physical Domain Score | Week 4 | 55.168 Score on a scale | Standard Error 0.962 |
| Placebo | 36-item-health Survey (SF-36) - Role Physical Domain Score | Week 24 | 53.138 Score on a scale | Standard Error 1.047 |
| Placebo | 36-item-health Survey (SF-36) - Role Physical Domain Score | Week 12 | 54.405 Score on a scale | Standard Error 0.986 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Physical Domain Score | Week 12 | 57.271 Score on a scale | Standard Error 0.983 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Physical Domain Score | Week 4 | 57.326 Score on a scale | Standard Error 0.959 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Physical Domain Score | Week 24 | 57.095 Score on a scale | Standard Error 1.044 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Physical Domain Score | Week 12 | 57.186 Score on a scale | Standard Error 0.993 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Physical Domain Score | Week 4 | 57.469 Score on a scale | Standard Error 0.969 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Physical Domain Score | Week 24 | 54.934 Score on a scale | Standard Error 1.055 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Physical Domain Score | Week 4 | 56.898 Score on a scale | Standard Error 1 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Physical Domain Score | Week 24 | 55.871 Score on a scale | Standard Error 1.087 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Physical Domain Score | Week 12 | 56.938 Score on a scale | Standard Error 1.024 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Physical Domain Score | Week 12 | 57.417 Score on a scale | Standard Error 0.978 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Physical Domain Score | Week 4 | 57.950 Score on a scale | Standard Error 0.954 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Role Physical Domain Score | Week 24 | 57.020 Score on a scale | Standard Error 1.038 |
Secondary
36-item-health Survey (SF-36) - Social Functioning Domain Score
The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of Social functioning (based on 2 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the social functioning.
Time frame: At Week 4, 12, and 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement. Only patients with non-missing outcomes are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 36-item-health Survey (SF-36) - Social Functioning Domain Score | Week 4 | 75.574 Score on a scale | Standard Error 0.919 |
| Placebo | 36-item-health Survey (SF-36) - Social Functioning Domain Score | Week 24 | 71.440 Score on a scale | Standard Error 1.062 |
| Placebo | 36-item-health Survey (SF-36) - Social Functioning Domain Score | Week 12 | 73.093 Score on a scale | Standard Error 0.982 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Social Functioning Domain Score | Week 12 | 76.801 Score on a scale | Standard Error 0.979 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Social Functioning Domain Score | Week 4 | 76.235 Score on a scale | Standard Error 0.916 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Social Functioning Domain Score | Week 24 | 75.157 Score on a scale | Standard Error 1.059 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Social Functioning Domain Score | Week 12 | 75.108 Score on a scale | Standard Error 0.989 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Social Functioning Domain Score | Week 4 | 76.418 Score on a scale | Standard Error 0.926 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Social Functioning Domain Score | Week 24 | 74.295 Score on a scale | Standard Error 1.07 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Social Functioning Domain Score | Week 4 | 77.177 Score on a scale | Standard Error 0.954 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Social Functioning Domain Score | Week 24 | 75.520 Score on a scale | Standard Error 1.102 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Social Functioning Domain Score | Week 12 | 75.798 Score on a scale | Standard Error 1.018 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Social Functioning Domain Score | Week 12 | 76.992 Score on a scale | Standard Error 0.974 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Social Functioning Domain Score | Week 4 | 77.053 Score on a scale | Standard Error 0.912 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Social Functioning Domain Score | Week 24 | 73.993 Score on a scale | Standard Error 1.054 |
Secondary
36-item-health Survey (SF-36) - Vitality Domain Score
The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of vitality (based on 4 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the more vitality and less fatigue one has.
Time frame: At Week 4, 12, and 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement. Only patients with non-missing outcomes are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 36-item-health Survey (SF-36) - Vitality Domain Score | Week 4 | 52.501 Score on a scale | Standard Error 0.716 |
| Placebo | 36-item-health Survey (SF-36) - Vitality Domain Score | Week 12 | 51.676 Score on a scale | Standard Error 0.759 |
| Placebo | 36-item-health Survey (SF-36) - Vitality Domain Score | Week 24 | 51.188 Score on a scale | Standard Error 0.804 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Vitality Domain Score | Week 24 | 52.892 Score on a scale | Standard Error 0.801 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Vitality Domain Score | Week 4 | 53.516 Score on a scale | Standard Error 0.713 |
| BEA 2180 BR 50 Microgram (mcg) | 36-item-health Survey (SF-36) - Vitality Domain Score | Week 12 | 53.670 Score on a scale | Standard Error 0.756 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Vitality Domain Score | Week 4 | 54.084 Score on a scale | Standard Error 0.721 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Vitality Domain Score | Week 12 | 53.947 Score on a scale | Standard Error 0.765 |
| BEA 2180 BR 100 Microgram (mcg) | 36-item-health Survey (SF-36) - Vitality Domain Score | Week 24 | 54.080 Score on a scale | Standard Error 0.81 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Vitality Domain Score | Week 4 | 53.630 Score on a scale | Standard Error 0.743 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Vitality Domain Score | Week 12 | 53.935 Score on a scale | Standard Error 0.788 |
| BEA 2180 BR 200 Microgram (mcg) | 36-item-health Survey (SF-36) - Vitality Domain Score | Week 24 | 54.211 Score on a scale | Standard Error 0.833 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Vitality Domain Score | Week 4 | 54.881 Score on a scale | Standard Error 0.71 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Vitality Domain Score | Week 24 | 54.542 Score on a scale | Standard Error 0.798 |
| Tiotropium Bromide 5 Microgram (mcg) | 36-item-health Survey (SF-36) - Vitality Domain Score | Week 12 | 55.317 Score on a scale | Standard Error 0.753 |
Secondary
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks
Forced expiratory volume in one second (FEV1) area under the curve from 0 to 3 hours (AUC0-3h) response after 0, 4, 12 and 24 weeks are reported. The FEV1 AUC0-3h response is the area under the curve from 0 to 3 hours post drug administration for change from baseline values of FEV1. The area under the curve (AUC) is calculated as the area under the curve from 0 to 3 hours at weeks 0, 4, 12 and 24 using the trapezoidal rule and using planned time, divided by the full duration (3 hours) to report in litres. The mean of the pre-dose values (at 40 minutes and 15 minutes before dosing) are used with a time value of zero for calculating the AUC values starting at zero. The baseline FEV1 is the mean of the two measurements taken at 40 and 15 minutes before drug administration at Day 1 of treatment period.
Time frame: 40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 0 | 0.029 litre | Standard Error 0.007 |
| Placebo | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 12 | 0.019 litre | Standard Error 0.011 |
| Placebo | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 24 | -0.007 litre | Standard Error 0.011 |
| Placebo | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 4 | 0.021 litre | Standard Error 0.01 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 24 | 0.140 litre | Standard Error 0.011 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 0 | 0.172 litre | Standard Error 0.007 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 12 | 0.164 litre | Standard Error 0.011 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 4 | 0.166 litre | Standard Error 0.01 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 0 | 0.186 litre | Standard Error 0.007 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 24 | 0.150 litre | Standard Error 0.011 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 12 | 0.166 litre | Standard Error 0.011 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 4 | 0.175 litre | Standard Error 0.01 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 0 | 0.177 litre | Standard Error 0.007 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 24 | 0.146 litre | Standard Error 0.012 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 12 | 0.166 litre | Standard Error 0.011 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 4 | 0.165 litre | Standard Error 0.011 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 0 | 0.165 litre | Standard Error 0.007 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 24 | 0.177 litre | Standard Error 0.011 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 4 | 0.203 litre | Standard Error 0.01 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 12 | 0.203 litre | Standard Error 0.011 |
Secondary
Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration
Forced expiratory volume in one second (FEV1) values at 3 minutes and 10 minutes following drug administration at Week 0, 4, 12, and 24 are reported.
Time frame: 3 minutes (min) and 10 after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24.
Population: Sub-study set (SUB): This patient set includes all patients in the full analysis set that were enrolled in the sub-study (at selected sites only) and have acceptable non-missing forced expiratory volume in one second (FEV1) data from 2 additional visits on Day 3 and 5.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 - 3 minutes (min) | 1.128 litre | Standard Error 0.015 |
| Placebo | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 -10 min | 1.135 litre | Standard Error 0.018 |
| Placebo | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 3 min | 1.161 litre | Standard Error 0.026 |
| Placebo | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 10 min | 1.160 litre | Standard Error 0.028 |
| Placebo | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 3 min | 1.151 litre | Standard Error 0.028 |
| Placebo | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 10 min | 1.172 litre | Standard Error 0.027 |
| Placebo | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 3 min | 1.115 litre | Standard Error 0.029 |
| Placebo | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 10 min | 1.138 litre | Standard Error 0.032 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 3 min | 1.208 litre | Standard Error 0.025 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 10 min | 1.258 litre | Standard Error 0.027 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 - 3 minutes (min) | 1.195 litre | Standard Error 0.015 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 10 min | 1.252 litre | Standard Error 0.027 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 -10 min | 1.253 litre | Standard Error 0.017 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 10 min | 1.240 litre | Standard Error 0.031 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 3 min | 1.233 litre | Standard Error 0.027 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 3 min | 1.196 litre | Standard Error 0.029 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 3 min | 1.230 litre | Standard Error 0.029 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 10 min | 1.278 litre | Standard Error 0.031 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 10 min | 1.312 litre | Standard Error 0.028 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 10 min | 1.304 litre | Standard Error 0.027 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 3 min | 1.259 litre | Standard Error 0.025 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 -10 min | 1.268 litre | Standard Error 0.017 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 - 3 minutes (min) | 1.185 litre | Standard Error 0.015 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 3 min | 1.251 litre | Standard Error 0.027 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 -10 min | 1.224 litre | Standard Error 0.018 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 3 min | 1.227 litre | Standard Error 0.026 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 10 min | 1.252 litre | Standard Error 0.028 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 3 min | 1.258 litre | Standard Error 0.028 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 10 min | 1.279 litre | Standard Error 0.027 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 10 min | 1.244 litre | Standard Error 0.032 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 - 3 minutes (min) | 1.147 litre | Standard Error 0.015 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 3 min | 1.211 litre | Standard Error 0.03 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 10 min | 1.301 litre | Standard Error 0.029 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 10 min | 1.329 litre | Standard Error 0.032 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 3 min | 1.260 litre | Standard Error 0.026 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 3 min | 1.301 litre | Standard Error 0.03 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 - 3 minutes (min) | 1.206 litre | Standard Error 0.016 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 10 min | 1.336 litre | Standard Error 0.028 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 -10 min | 1.247 litre | Standard Error 0.018 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 3 min | 1.310 litre | Standard Error 0.028 |
Secondary
Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks
Forced expiratory volume in one second (FEV1) peak response after 0, 4, 12, and 24 weeks were reported. Peak FEV1 response was the maximum change from baseline for the post-dose measurements of FEV1. Baseline FEV1 is the mean of the two measurements taken at 40 and 15 minutes before drug administration.
Time frame: 40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 12 | 0.078 litre | Standard Error 0.011 |
| Placebo | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 0 | 0.103 litre | Standard Error 0.008 |
| Placebo | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 4 | 0.090 litre | Standard Error 0.011 |
| Placebo | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 24 | 0.051 litre | Standard Error 0.012 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 4 | 0.237 litre | Standard Error 0.011 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 0 | 0.246 litre | Standard Error 0.008 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 12 | 0.236 litre | Standard Error 0.011 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 24 | 0.207 litre | Standard Error 0.012 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 0 | 0.260 litre | Standard Error 0.08 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 24 | 0.216 litre | Standard Error 0.012 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 4 | 0.250 litre | Standard Error 0.011 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 12 | 0.236 litre | Standard Error 0.012 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 0 | 0.266 litre | Standard Error 0.009 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 24 | 0.216 litre | Standard Error 0.012 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 12 | 0.241 litre | Standard Error 0.012 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 4 | 0.243 litre | Standard Error 0.011 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 24 | 0.242 litre | Standard Error 0.012 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 0 | 0.246 litre | Standard Error 0.008 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 4 | 0.274 litre | Standard Error 0.011 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks | Week 12 | 0.273 litre | Standard Error 0.011 |
Secondary
Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks
Forced vital capacity (FVC) area under the curve from 0 to 3 hours (AUC0-3h) response after 0, 4, 12 and 24 weeks are reported. The FVC AUC0-3h response is the area under the curve from 0 to 3 hours post drug administration for change from baseline values of FVC. The area under the curve (AUC) is calculated as the area under the curve from 0 to 3 hours at weeks 0, 4, 12 and 24 using the trapezoidal rule and using planned time, divided by the full duration (3 hours) to report in litres. The mean of the pre-dose values (at 40 minutes and 15 minutes before dosing) are used with a time value of zero for calculating the AUC values starting at zero. The baseline FVC is the mean of the two measurements taken at 40 and 15 minutes before drug administration at Day 1 of treatment period.
Time frame: 40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 0 | 0.067 litre | Standard Error 0.015 |
| Placebo | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 4 | 0.050 litre | Standard Error 0.019 |
| Placebo | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 12 | 0.053 litre | Standard Error 0.02 |
| Placebo | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 24 | -0.002 litre | Standard Error 0.021 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 0 | 0.321 litre | Standard Error 0.015 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 24 | 0.233 litre | Standard Error 0.021 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 4 | 0.292 litre | Standard Error 0.019 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 12 | 0.276 litre | Standard Error 0.02 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 24 | 0.218 litre | Standard Error 0.022 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 4 | 0.298 litre | Standard Error 0.02 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 12 | 0.278 litre | Standard Error 0.021 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 0 | 0.336 litre | Standard Error 0.015 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 0 | 0.302 litre | Standard Error 0.015 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 4 | 0.247 litre | Standard Error 0.02 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 24 | 0.210 litre | Standard Error 0.022 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 12 | 0.251 litre | Standard Error 0.021 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 24 | 0.274 litre | Standard Error 0.021 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 12 | 0.326 litre | Standard Error 0.02 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 4 | 0.340 litre | Standard Error 0.019 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks | Week 0 | 0.312 litre | Standard Error 0.015 |
Secondary
Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration
Forced Vital Capacity (FVC) values at 3 minutes and 10 minutes following drug administration at Week 0, 4, 12, and 24 are reported.
Time frame: 3 minutes (min) and 10 min after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24.
Population: Sub-study set (SUB): This patient set includes all patients in the full analysis set that were enrolled in the sub-study (at selected sites only) and have acceptable non-missing forced expiratory volume in one second (FEV1) data from 2 additional visits on Day 3 and 5.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 - 3 minutes (min) | 2.381 litre | Standard Error 0.028 |
| Placebo | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 - 10 min | 2.392 litre | Standard Error 0.034 |
| Placebo | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 3 min | 2.391 litre | Standard Error 0.044 |
| Placebo | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 10 min | 2.391 litre | Standard Error 0.049 |
| Placebo | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 3 min | 2.395 litre | Standard Error 0.048 |
| Placebo | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 10 min | 2.417 litre | Standard Error 0.05 |
| Placebo | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 3 min | 2.355 litre | Standard Error 0.054 |
| Placebo | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 10 min | 2.403 litre | Standard Error 0.058 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 3 min | 2.623 litre | Standard Error 0.043 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 10 min | 2.648 litre | Standard Error 0.049 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 - 3 minutes (min) | 2.530 litre | Standard Error 0.027 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 10 min | 2.693 litre | Standard Error 0.048 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 - 10 min | 2.624 litre | Standard Error 0.033 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 10 min | 2.635 litre | Standard Error 0.057 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 3 min | 2.594 litre | Standard Error 0.047 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 3 min | 2.566 litre | Standard Error 0.053 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 3 min | 2.556 litre | Standard Error 0.053 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 10 min | 2.599 litre | Standard Error 0.057 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 10 min | 2.697 litre | Standard Error 0.048 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 10 min | 2.637 litre | Standard Error 0.049 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 3 min | 2.638 litre | Standard Error 0.044 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 - 10 min | 2.658 litre | Standard Error 0.033 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 - 3 minutes (min) | 2.535 litre | Standard Error 0.027 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 3 min | 2.604 litre | Standard Error 0.048 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 - 10 min | 2.557 litre | Standard Error 0.034 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 3 min | 2.523 litre | Standard Error 0.044 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 10 min | 2.540 litre | Standard Error 0.049 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 3 min | 2.549 litre | Standard Error 0.049 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 10 min | 2.579 litre | Standard Error 0.05 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 10 min | 2.545 litre | Standard Error 0.058 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 - 3 minutes (min) | 2.455 litre | Standard Error 0.028 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 3 min | 2.513 litre | Standard Error 0.054 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 10 min | 2.634 litre | Standard Error 0.05 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 10 min | 2.664 litre | Standard Error 0.059 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 4 - 3 min | 2.601 litre | Standard Error 0.045 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 24 - 3 min | 2.624 litre | Standard Error 0.055 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 - 3 minutes (min) | 2.500 litre | Standard Error 0.028 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 10 min | 2.646 litre | Standard Error 0.051 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 0 - 10 min | 2.593 litre | Standard Error 0.034 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration | Week 12 - 3 min | 2.631 litre | Standard Error 0.049 |
Secondary
Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks
Forced Vital Capacity (FVC) peak response after 0, 4, 12, and 24 weeks were reported. Peak FVC response was the maximum change from baseline for the post-dose measurements of FVC. Baseline FVC is the mean of the two measurements taken at 40 and 15 minutes before drug administration.
Time frame: 40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 0 | 0.216 litre | Standard Error 0.018 |
| Placebo | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 4 | 0.186 litre | Standard Error 0.021 |
| Placebo | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 12 | 0.177 litre | Standard Error 0.022 |
| Placebo | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 24 | 0.122 litre | Standard Error 0.023 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 0 | 0.474 litre | Standard Error 0.018 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 24 | 0.369 litre | Standard Error 0.023 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 4 | 0.434 litre | Standard Error 0.021 |
| BEA 2180 BR 50 Microgram (mcg) | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 12 | 0.417 litre | Standard Error 0.022 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 24 | 0.345 litre | Standard Error 0.023 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 4 | 0.449 litre | Standard Error 0.021 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 12 | 0.412 litre | Standard Error 0.023 |
| BEA 2180 BR 100 Microgram (mcg) | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 0 | 0.478 litre | Standard Error 0.018 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 0 | 0.463 litre | Standard Error 0.019 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 4 | 0.386 litre | Standard Error 0.022 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 24 | 0.335 litre | Standard Error 0.024 |
| BEA 2180 BR 200 Microgram (mcg) | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 12 | 0.384 litre | Standard Error 0.023 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 24 | 0.393 litre | Standard Error 0.023 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 12 | 0.463 litre | Standard Error 0.022 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 4 | 0.479 litre | Standard Error 0.021 |
| Tiotropium Bromide 5 Microgram (mcg) | Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks | Week 0 | 0.463 litre | Standard Error 0.018 |
Secondary
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation is reported. A Chronic Obstructive Pulmonary Disease (COPD) exacerbation is defined as a complex of lower respiratory events / symptoms (increase or new onset) related to the underlying COPD, with a duration of three days or more, requiring a change in treatment, where a complex of lower respiratory events / symptoms means at least two of the following: Shortness of breath, Sputum production (volume), Occurrence of purulent sputum, Cough, Wheezing, Chest tightness.
Time frame: From first does until 30 days after the end of treatment, up to 205 days.
Population: Treated Set (TS): The treated set was defined as all patients who were randomized and who took at least one dose of trial medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 0.5797 Events per patient-year |
| BEA 2180 BR 50 Microgram (mcg) | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 0.4345 Events per patient-year |
| BEA 2180 BR 100 Microgram (mcg) | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 0.4898 Events per patient-year |
| BEA 2180 BR 200 Microgram (mcg) | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 0.4373 Events per patient-year |
| Tiotropium Bromide 5 Microgram (mcg) | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 0.5332 Events per patient-year |
Secondary
Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point
Individual Forced expiratory volume in one second (FEV1) values measured at each time points at Week 0, 4, 12, and 24 were reported.
Time frame: 15 minutes (min), 30 min, 1 hour (h), 2 h, 3 h after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24. At 0 min (at drug administration) at Week 4, 12, and 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 15 minutes (min) | 1.200 litre | Standard Error 0.006 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 0:15 min | 1.164 litre | Standard Error 0.011 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 0 min | 1.163 litre | Standard Error 0.009 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 30 min | 1.196 litre | Standard Error 0.011 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 3 h | 1.211 litre | Standard Error 0.011 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 1 h | 1.180 litre | Standard Error 0.012 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 0 min | 1.150 litre | Standard Error 0.01 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 15 min | 1.187 litre | Standard Error 0.01 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 2 h | 1.212 litre | Standard Error 0.008 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 15 min | 1.188 litre | Standard Error 0.011 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 3 h | 1.180 litre | Standard Error 0.012 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 3 h | 1.205 litre | Standard Error 0.011 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 30 min | 1.200 litre | Standard Error 0.01 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 0 min | 1.174 litre | Standard Error 0.01 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 30 min | 1.170 litre | Standard Error 0.011 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 3 h | 1.220 litre | Standard Error 0.009 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 2 h | 1.205 litre | Standard Error 0.011 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 1 h | 1.207 litre | Standard Error 0.011 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 1 hour (h) | 1.223 litre | Standard Error 0.008 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 2 h | 1.180 litre | Standard Error 0.012 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 30 min | 1.206 litre | Standard Error 0.007 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 1 h | 1.209 litre | Standard Error 0.011 |
| Placebo | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 2 h | 1.211 litre | Standard Error 0.011 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 0 min | 1.227 litre | Standard Error 0.01 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 30 min | 1.348 litre | Standard Error 0.011 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 3 h | 1.355 litre | Standard Error 0.011 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 1 hour (h) | 1.375 litre | Standard Error 0.008 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 15 min | 1.321 litre | Standard Error 0.011 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 0 min | 1.249 litre | Standard Error 0.01 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 3 h | 1.326 litre | Standard Error 0.012 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 1 h | 1.338 litre | Standard Error 0.012 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 2 h | 1.373 litre | Standard Error 0.008 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 30 min | 1.318 litre | Standard Error 0.012 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 3 h | 1.363 litre | Standard Error 0.009 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 0:15 min | 1.297 litre | Standard Error 0.011 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 0 min | 1.249 litre | Standard Error 0.009 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 30 min | 1.347 litre | Standard Error 0.007 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 2 h | 1.360 litre | Standard Error 0.011 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 15 min | 1.319 litre | Standard Error 0.01 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 15 minutes (min) | 1.309 litre | Standard Error 0.006 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 3 h | 1.352 litre | Standard Error 0.012 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 30 min | 1.346 litre | Standard Error 0.01 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 2 h | 1.332 litre | Standard Error 0.012 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 2 h | 1.357 litre | Standard Error 0.011 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 1 h | 1.360 litre | Standard Error 0.011 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 1 h | 1.358 litre | Standard Error 0.011 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 0 min | 1.267 litre | Standard Error 0.01 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 15 minutes (min) | 1.310 litre | Standard Error 0.006 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 30 min | 1.357 litre | Standard Error 0.007 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 1 hour (h) | 1.390 litre | Standard Error 0.008 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 2 h | 1.388 litre | Standard Error 0.008 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 3 h | 1.389 litre | Standard Error 0.009 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 0 min | 1.274 litre | Standard Error 0.009 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 15 min | 1.321 litre | Standard Error 0.01 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 30 min | 1.346 litre | Standard Error 0.011 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 1 h | 1.366 litre | Standard Error 0.011 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 2 h | 1.372 litre | Standard Error 0.011 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 3 h | 1.368 litre | Standard Error 0.011 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 15 min | 1.313 litre | Standard Error 0.011 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 30 min | 1.335 litre | Standard Error 0.011 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 1 h | 1.356 litre | Standard Error 0.011 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 2 h | 1.365 litre | Standard Error 0.011 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 3 h | 1.363 litre | Standard Error 0.012 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 0 min | 1.250 litre | Standard Error 0.011 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 0:15 min | 1.298 litre | Standard Error 0.011 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 30 min | 1.320 litre | Standard Error 0.012 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 1 h | 1.342 litre | Standard Error 0.012 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 2 h | 1.345 litre | Standard Error 0.012 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 3 h | 1.344 litre | Standard Error 0.012 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 1 h | 1.350 litre | Standard Error 0.011 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 0:15 min | 1.278 litre | Standard Error 0.012 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 15 min | 1.279 litre | Standard Error 0.01 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 2 h | 1.346 litre | Standard Error 0.012 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 2 h | 1.395 litre | Standard Error 0.008 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 15 minutes (min) | 1.263 litre | Standard Error 0.006 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 30 min | 1.296 litre | Standard Error 0.012 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 3 h | 1.384 litre | Standard Error 0.012 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 30 min | 1.318 litre | Standard Error 0.007 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 1 hour (h) | 1.369 litre | Standard Error 0.008 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 30 min | 1.308 litre | Standard Error 0.011 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 1 h | 1.331 litre | Standard Error 0.012 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 0 min | 1.291 litre | Standard Error 0.01 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 0 min | 1.284 litre | Standard Error 0.009 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 3 h | 1.357 litre | Standard Error 0.012 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 3 h | 1.380 litre | Standard Error 0.012 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 0 min | 1.270 litre | Standard Error 0.011 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 15 min | 1.292 litre | Standard Error 0.011 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 2 h | 1.372 litre | Standard Error 0.012 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 1 h | 1.345 litre | Standard Error 0.011 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 2 h | 1.372 litre | Standard Error 0.011 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 3 h | 1.403 litre | Standard Error 0.009 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 30 min | 1.313 litre | Standard Error 0.011 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 15 minutes (min) | 1.276 litre | Standard Error 0.006 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 1 h | 1.397 litre | Standard Error 0.011 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 1 h | 1.391 litre | Standard Error 0.011 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 30 min | 1.374 litre | Standard Error 0.01 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 2 h | 1.401 litre | Standard Error 0.011 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 15 min | 1.348 litre | Standard Error 0.01 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 3 h | 1.401 litre | Standard Error 0.011 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 0 min | 1.283 litre | Standard Error 0.009 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 2 h | 1.373 litre | Standard Error 0.012 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 0 min | 1.276 litre | Standard Error 0.01 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 3 h | 1.388 litre | Standard Error 0.009 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 30 min | 1.371 litre | Standard Error 0.011 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 0:15 min | 1.326 litre | Standard Error 0.011 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 2 h | 1.378 litre | Standard Error 0.008 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 30 min | 1.355 litre | Standard Error 0.011 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 1 hour (h) | 1.353 litre | Standard Error 0.008 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 3 h | 1.370 litre | Standard Error 0.012 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 0 min | 1.293 litre | Standard Error 0.01 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 3 h | 1.401 litre | Standard Error 0.011 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 24 - 1 h | 1.368 litre | Standard Error 0.012 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 12 - 15 min | 1.354 litre | Standard Error 0.011 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 4 - 2 h | 1.401 litre | Standard Error 0.011 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point | Week 0 - 30 min | 1.311 litre | Standard Error 0.007 |
Secondary
Individual Forced Vital Capacity (FVC) Measurements at Each Time Point
Individual Forced Vital Capacity (FVC) values measured at each time point at Week 0, 4, 12, and 24 were reported.
Time frame: 15 minutes (min), 30 min, 1 hour (h), 2 h, 3 h after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24. At 0 min (at drug administration) at Week 4, 12, and 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 2 h | 2.592 litre | Standard Error 0.021 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 1 h | 2.539 litre | Standard Error 0.022 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 1 h | 2.606 litre | Standard Error 0.021 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 0 minutes | 2.510 litre | Standard Error 0.016 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 15 min | 2.563 litre | Standard Error 0.02 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 1 h | 2.590 litre | Standard Error 0.02 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 30 min | 2.589 litre | Standard Error 0.015 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 2 h | 2.533 litre | Standard Error 0.023 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 15 minutes | 2.547 litre | Standard Error 0.019 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 2 h | 2.598 litre | Standard Error 0.017 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 30 min | 2.575 litre | Standard Error 0.02 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24- 30 min | 2.520 litre | Standard Error 0.022 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 3 h | 2.588 litre | Standard Error 0.022 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 30 minutes | 2.574 litre | Standard Error 0.02 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 0 min | 2.533 litre | Standard Error 0.018 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 3 h | 2.547 litre | Standard Error 0.023 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 15 min | 2.504 litre | Standard Error 0.021 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 0 min | 2.489 litre | Standard Error 0.019 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 1 hour (h) | 2.617 litre | Standard Error 0.016 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 15 minutes (min) | 2.572 litre | Standard Error 0.013 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 3 h | 2.595 litre | Standard Error 0.021 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 3 h | 2.617 litre | Standard Error 0.019 |
| Placebo | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 2 h | 2.584 litre | Standard Error 0.022 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 3 h | 2.842 litre | Standard Error 0.021 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 15 min | 2.725 litre | Standard Error 0.021 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 1 h | 2.823 litre | Standard Error 0.021 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 2 h | 2.828 litre | Standard Error 0.022 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 3 h | 2.819 litre | Standard Error 0.022 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 2 h | 2.881 litre | Standard Error 0.017 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 0 min | 2.614 litre | Standard Error 0.019 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 3 h | 2.867 litre | Standard Error 0.019 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 2 h | 2.778 litre | Standard Error 0.023 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 0 minutes | 2.665 litre | Standard Error 0.016 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 15 minutes | 2.770 litre | Standard Error 0.019 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 30 min | 2.854 litre | Standard Error 0.015 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 30 min | 2.812 litre | Standard Error 0.02 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 1 h | 2.793 litre | Standard Error 0.022 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 1 h | 2.842 litre | Standard Error 0.02 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 15 minutes (min) | 2.787 litre | Standard Error 0.013 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 2 h | 2.842 litre | Standard Error 0.021 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 3 h | 2.769 litre | Standard Error 0.024 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24- 30 min | 2.753 litre | Standard Error 0.022 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 0 min | 2.654 litre | Standard Error 0.018 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 1 hour (h) | 2.885 litre | Standard Error 0.017 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 15 min | 2.764 litre | Standard Error 0.02 |
| BEA 2180 BR 50 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 30 minutes | 2.796 litre | Standard Error 0.02 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 3 h | 2.896 litre | Standard Error 0.019 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 30 minutes | 2.788 litre | Standard Error 0.021 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 2 h | 2.851 litre | Standard Error 0.021 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 15 min | 2.751 litre | Standard Error 0.02 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24- 30 min | 2.724 litre | Standard Error 0.022 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 2 h | 2.770 litre | Standard Error 0.023 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 15 minutes (min) | 2.778 litre | Standard Error 0.013 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 3 h | 2.849 litre | Standard Error 0.022 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 2 h | 2.896 litre | Standard Error 0.018 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 1 hour (h) | 2.907 litre | Standard Error 0.017 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 3 h | 2.836 litre | Standard Error 0.022 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 15 min | 2.705 litre | Standard Error 0.021 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 1 h | 2.763 litre | Standard Error 0.022 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 15 minutes | 2.776 litre | Standard Error 0.019 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 0 min | 2.687 litre | Standard Error 0.018 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 30 min | 2.803 litre | Standard Error 0.02 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 30 min | 2.852 litre | Standard Error 0.015 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 1 h | 2.821 litre | Standard Error 0.022 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 0 minutes | 2.689 litre | Standard Error 0.016 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 0 min | 2.637 litre | Standard Error 0.019 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 1 h | 2.848 litre | Standard Error 0.021 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 2 h | 2.829 litre | Standard Error 0.022 |
| BEA 2180 BR 100 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 3 h | 2.766 litre | Standard Error 0.024 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 1 hour (h) | 2.853 litre | Standard Error 0.017 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 15 minutes (min) | 2.691 litre | Standard Error 0.013 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 30 min | 2.776 litre | Standard Error 0.016 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 1 h | 2.739 litre | Standard Error 0.023 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 2 h | 2.886 litre | Standard Error 0.018 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 3 h | 2.896 litre | Standard Error 0.019 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 0 minutes | 2.688 litre | Standard Error 0.017 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 15 minutes | 2.670 litre | Standard Error 0.019 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 30 min | 2.711 litre | Standard Error 0.02 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 1 h | 2.779 litre | Standard Error 0.021 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 2 h | 2.815 litre | Standard Error 0.022 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 3 h | 2.837 litre | Standard Error 0.022 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 0 min | 2.703 litre | Standard Error 0.018 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 15 min | 2.688 litre | Standard Error 0.021 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 30 minutes | 2.720 litre | Standard Error 0.021 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 1 h | 2.773 litre | Standard Error 0.022 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 2 h | 2.820 litre | Standard Error 0.023 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 3 h | 2.840 litre | Standard Error 0.023 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 0 min | 2.664 litre | Standard Error 0.02 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 15 min | 2.667 litre | Standard Error 0.022 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24- 30 min | 2.690 litre | Standard Error 0.022 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 2 h | 2.771 litre | Standard Error 0.023 |
| BEA 2180 BR 200 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 3 h | 2.789 litre | Standard Error 0.024 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 30 minutes | 2.844 litre | Standard Error 0.02 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 15 min | 2.803 litre | Standard Error 0.02 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 30 min | 2.802 litre | Standard Error 0.015 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 15 min | 2.761 litre | Standard Error 0.021 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 0 min | 2.711 litre | Standard Error 0.018 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 3 h | 2.891 litre | Standard Error 0.021 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 2 h | 2.893 litre | Standard Error 0.021 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 15 minutes (min) | 2.729 litre | Standard Error 0.013 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24- 30 min | 2.803 litre | Standard Error 0.022 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 1 h | 2.891 litre | Standard Error 0.02 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 30 min | 2.852 litre | Standard Error 0.02 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 15 minutes | 2.822 litre | Standard Error 0.019 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 1 h | 2.823 litre | Standard Error 0.022 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 4 - 0 minutes | 2.702 litre | Standard Error 0.016 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 3 h | 2.901 litre | Standard Error 0.019 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 2 h | 2.885 litre | Standard Error 0.017 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 3 h | 2.806 litre | Standard Error 0.023 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 2 h | 2.822 litre | Standard Error 0.022 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 3 h | 2.886 litre | Standard Error 0.022 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 2 h | 2.878 litre | Standard Error 0.022 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 0 - 1 hour (h) | 2.864 litre | Standard Error 0.016 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 24 - 0 min | 2.678 litre | Standard Error 0.019 |
| Tiotropium Bromide 5 Microgram (mcg) | Individual Forced Vital Capacity (FVC) Measurements at Each Time Point | Week 12 - 1 h | 2.866 litre | Standard Error 0.021 |
Secondary
Number of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Number of patients with at least one Chronic Obstructive Pulmonary Disease (COPD) exacerbation is reported. Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation is reported. A Chronic Obstructive Pulmonary Disease (COPD) exacerbation is defined as a complex of lower respiratory events / symptoms (increase or new onset) related to the underlying COPD, with a duration of three days or more, requiring a change in treatment, where a complex of lower respiratory events / symptoms means at least two of the following: Shortness of breath, Sputum production (volume), Occurrence of purulent sputum, Cough, Wheezing, Chest tightness.
Time frame: From first does until 30 days after the end of treatment, up to 205 days.
Population: Treated Set (TS): The treated set was defined as all patients who were randomized and who took at least one dose of trial medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 85 Participants |
| BEA 2180 BR 50 Microgram (mcg) | Number of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 60 Participants |
| BEA 2180 BR 100 Microgram (mcg) | Number of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 77 Participants |
| BEA 2180 BR 200 Microgram (mcg) | Number of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 57 Participants |
| Tiotropium Bromide 5 Microgram (mcg) | Number of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 73 Participants |
Secondary
Physician's Global Evaluation
Physicians make a global evaluation reflecting the physician's global opinion of the overall clinical condition of the patient as poor (score 1 or 2), fair (score 3 or 4), good (score 5 or 6), or excellent (score 7 or 8). These assessments are made prior to pulmonary function testing and are summarized on pulmonary function test days. This evaluation was based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, and other relevant clinical observations. The score ranges from 1 to 8 with higher score indicating better overall clinical condition.
Time frame: At Week 0, 4, 12, and 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Physician's Global Evaluation | Week 0 | 4.4 Score on scale | Standard Error 1.2 |
| Placebo | Physician's Global Evaluation | Week 4 | 4.541 Score on scale | Standard Error 0.042 |
| Placebo | Physician's Global Evaluation | Week 12 | 4.582 Score on scale | Standard Error 0.047 |
| Placebo | Physician's Global Evaluation | Week 24 | 4.613 Score on scale | Standard Error 0.053 |
| BEA 2180 BR 50 Microgram (mcg) | Physician's Global Evaluation | Week 0 | 4.5 Score on scale | Standard Error 1.2 |
| BEA 2180 BR 50 Microgram (mcg) | Physician's Global Evaluation | Week 24 | 4.865 Score on scale | Standard Error 0.053 |
| BEA 2180 BR 50 Microgram (mcg) | Physician's Global Evaluation | Week 4 | 4.714 Score on scale | Standard Error 0.042 |
| BEA 2180 BR 50 Microgram (mcg) | Physician's Global Evaluation | Week 12 | 4.804 Score on scale | Standard Error 0.047 |
| BEA 2180 BR 100 Microgram (mcg) | Physician's Global Evaluation | Week 24 | 4.775 Score on scale | Standard Error 0.054 |
| BEA 2180 BR 100 Microgram (mcg) | Physician's Global Evaluation | Week 4 | 4.747 Score on scale | Standard Error 0.042 |
| BEA 2180 BR 100 Microgram (mcg) | Physician's Global Evaluation | Week 12 | 4.790 Score on scale | Standard Error 0.047 |
| BEA 2180 BR 100 Microgram (mcg) | Physician's Global Evaluation | Week 0 | 4.5 Score on scale | Standard Error 1.2 |
| BEA 2180 BR 200 Microgram (mcg) | Physician's Global Evaluation | Week 0 | 4.4 Score on scale | Standard Error 1.2 |
| BEA 2180 BR 200 Microgram (mcg) | Physician's Global Evaluation | Week 4 | 4.807 Score on scale | Standard Error 0.044 |
| BEA 2180 BR 200 Microgram (mcg) | Physician's Global Evaluation | Week 24 | 4.888 Score on scale | Standard Error 0.055 |
| BEA 2180 BR 200 Microgram (mcg) | Physician's Global Evaluation | Week 12 | 4.880 Score on scale | Standard Error 0.048 |
| Tiotropium Bromide 5 Microgram (mcg) | Physician's Global Evaluation | Week 24 | 4.810 Score on scale | Standard Error 0.053 |
| Tiotropium Bromide 5 Microgram (mcg) | Physician's Global Evaluation | Week 12 | 4.816 Score on scale | Standard Error 0.047 |
| Tiotropium Bromide 5 Microgram (mcg) | Physician's Global Evaluation | Week 4 | 4.739 Score on scale | Standard Error 0.042 |
| Tiotropium Bromide 5 Microgram (mcg) | Physician's Global Evaluation | Week 0 | 4.5 Score on scale | Standard Error 1.1 |
Secondary
St. George's Respiratory Questionnaire (SGRQ) Total Score
The St. George's Respiratory Questionnaire (SGRQ) is a well-established, self-completed tool measuring health-related quality of life in patients with diseases of airways obstruction on three aspects of symptoms, activity, and impacts. The total SGRQ score is reported, which ranges from 0 (the best score) to 100 (the worst score) with smaller score value indicating less limitations due to breathlessness and better quality of life.
Time frame: At Week 0, 4, 12, and 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement. Only patients with non-missing outcomes are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 0 | 43.2 Score on a scale | Standard Deviation 18.1 |
| Placebo | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 4 | 41.969 Score on a scale | Standard Deviation 0.486 |
| Placebo | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 12 | 42.744 Score on a scale | Standard Deviation 0.575 |
| Placebo | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 24 | 42.993 Score on a scale | Standard Deviation 0.626 |
| BEA 2180 BR 50 Microgram (mcg) | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 0 | 41.9 Score on a scale | Standard Deviation 17.5 |
| BEA 2180 BR 50 Microgram (mcg) | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 24 | 40.103 Score on a scale | Standard Deviation 0.624 |
| BEA 2180 BR 50 Microgram (mcg) | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 4 | 40.552 Score on a scale | Standard Deviation 0.484 |
| BEA 2180 BR 50 Microgram (mcg) | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 12 | 40.293 Score on a scale | Standard Deviation 0.573 |
| BEA 2180 BR 100 Microgram (mcg) | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 24 | 40.058 Score on a scale | Standard Deviation 0.632 |
| BEA 2180 BR 100 Microgram (mcg) | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 4 | 39.865 Score on a scale | Standard Deviation 0.49 |
| BEA 2180 BR 100 Microgram (mcg) | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 12 | 39.506 Score on a scale | Standard Deviation 0.58 |
| BEA 2180 BR 100 Microgram (mcg) | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 0 | 42.5 Score on a scale | Standard Deviation 17.7 |
| BEA 2180 BR 200 Microgram (mcg) | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 0 | 43.8 Score on a scale | Standard Deviation 18.8 |
| BEA 2180 BR 200 Microgram (mcg) | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 4 | 40.689 Score on a scale | Standard Deviation 0.506 |
| BEA 2180 BR 200 Microgram (mcg) | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 24 | 40.728 Score on a scale | Standard Deviation 0.651 |
| BEA 2180 BR 200 Microgram (mcg) | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 12 | 40.368 Score on a scale | Standard Deviation 0.596 |
| Tiotropium Bromide 5 Microgram (mcg) | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 24 | 39.547 Score on a scale | Standard Deviation 0.621 |
| Tiotropium Bromide 5 Microgram (mcg) | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 12 | 39.489 Score on a scale | Standard Deviation 0.57 |
| Tiotropium Bromide 5 Microgram (mcg) | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 4 | 40.706 Score on a scale | Standard Deviation 0.481 |
| Tiotropium Bromide 5 Microgram (mcg) | St. George's Respiratory Questionnaire (SGRQ) Total Score | Week 0 | 43.1 Score on a scale | Standard Deviation 17.8 |
Secondary
Transition Dyspnea Index - Functional Impairment Domain Score
The transitional dyspnea index (TDI) evaluates the patient's condition related to breathlessness. The TDI includes three domains: functional impairment, magnitude of task, and magnitude of effort. The TDI domain score of functional impairment is reported, which domain score ranges from -3 (major deterioration in the ability of working and doing activities due to shortness of breath; the worst score) to 3 (major improvement in the ability of working and doing activities; mild restriction on full activities due to the improvement of shortness of breath; the best score).
Time frame: At Week 0 (baseline), 4, 12 and 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Transition Dyspnea Index - Functional Impairment Domain Score | Week 0 | 2.3 Score on a scale | Standard Error 0.9 |
| Placebo | Transition Dyspnea Index - Functional Impairment Domain Score | Week 4 | 0.192 Score on a scale | Standard Error 0.048 |
| Placebo | Transition Dyspnea Index - Functional Impairment Domain Score | Week 12 | 0.276 Score on a scale | Standard Error 0.052 |
| Placebo | Transition Dyspnea Index - Functional Impairment Domain Score | Week 24 | 0.353 Score on a scale | Standard Error 0.054 |
| BEA 2180 BR 50 Microgram (mcg) | Transition Dyspnea Index - Functional Impairment Domain Score | Week 0 | 2.3 Score on a scale | Standard Error 0.9 |
| BEA 2180 BR 50 Microgram (mcg) | Transition Dyspnea Index - Functional Impairment Domain Score | Week 24 | 0.465 Score on a scale | Standard Error 0.054 |
| BEA 2180 BR 50 Microgram (mcg) | Transition Dyspnea Index - Functional Impairment Domain Score | Week 4 | 0.379 Score on a scale | Standard Error 0.048 |
| BEA 2180 BR 50 Microgram (mcg) | Transition Dyspnea Index - Functional Impairment Domain Score | Week 12 | 0.474 Score on a scale | Standard Error 0.052 |
| BEA 2180 BR 100 Microgram (mcg) | Transition Dyspnea Index - Functional Impairment Domain Score | Week 24 | 0.445 Score on a scale | Standard Error 0.055 |
| BEA 2180 BR 100 Microgram (mcg) | Transition Dyspnea Index - Functional Impairment Domain Score | Week 4 | 0.480 Score on a scale | Standard Error 0.049 |
| BEA 2180 BR 100 Microgram (mcg) | Transition Dyspnea Index - Functional Impairment Domain Score | Week 12 | 0.519 Score on a scale | Standard Error 0.053 |
| BEA 2180 BR 100 Microgram (mcg) | Transition Dyspnea Index - Functional Impairment Domain Score | Week 0 | 2.3 Score on a scale | Standard Error 0.9 |
| BEA 2180 BR 200 Microgram (mcg) | Transition Dyspnea Index - Functional Impairment Domain Score | Week 0 | 2.2 Score on a scale | Standard Error 0.9 |
| BEA 2180 BR 200 Microgram (mcg) | Transition Dyspnea Index - Functional Impairment Domain Score | Week 4 | 0.518 Score on a scale | Standard Error 0.05 |
| BEA 2180 BR 200 Microgram (mcg) | Transition Dyspnea Index - Functional Impairment Domain Score | Week 24 | 0.465 Score on a scale | Standard Error 0.056 |
| BEA 2180 BR 200 Microgram (mcg) | Transition Dyspnea Index - Functional Impairment Domain Score | Week 12 | 0.454 Score on a scale | Standard Error 0.054 |
| Tiotropium Bromide 5 Microgram (mcg) | Transition Dyspnea Index - Functional Impairment Domain Score | Week 24 | 0.488 Score on a scale | Standard Error 0.054 |
| Tiotropium Bromide 5 Microgram (mcg) | Transition Dyspnea Index - Functional Impairment Domain Score | Week 12 | 0.492 Score on a scale | Standard Error 0.052 |
| Tiotropium Bromide 5 Microgram (mcg) | Transition Dyspnea Index - Functional Impairment Domain Score | Week 4 | 0.462 Score on a scale | Standard Error 0.048 |
| Tiotropium Bromide 5 Microgram (mcg) | Transition Dyspnea Index - Functional Impairment Domain Score | Week 0 | 2.3 Score on a scale | Standard Error 0.9 |
Secondary
Transition Dyspnea Index - Magnitude of Effort Domain Score
The transitional dyspnea index (TDI) evaluates the patient's condition related to breathlessness. The TDI includes three domains: functional impairment, magnitude of task, and magnitude of effort. The TDI domain score of magnitude of effort is reported, which sub-score ranges from -3 (severe decrease in effort from baseline to avoid shortness of breath. Activities now take 50-100% longer to complete than required at baseline; the worst score) to 3 (Able to do things with much greater effort than previously with few pauses. Activities may be performed 50- 100% more rapidly than at baseline; the best score).
Time frame: At Week 0 (baseline), 4, 12 and 24
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 0 | 2.1 Score on a scale | Standard Error 0.7 |
| Placebo | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 4 | 0.161 Score on a scale | Standard Error 0.048 |
| Placebo | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 24 | 0.273 Score on a scale | Standard Error 0.057 |
| Placebo | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 12 | 0.253 Score on a scale | Standard Error 0.054 |
| BEA 2180 BR 50 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 12 | 0.423 Score on a scale | Standard Error 0.054 |
| BEA 2180 BR 50 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 0 | 2.0 Score on a scale | Standard Error 0.8 |
| BEA 2180 BR 50 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 4 | 0.437 Score on a scale | Standard Error 0.048 |
| BEA 2180 BR 50 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 24 | 0.458 Score on a scale | Standard Error 0.057 |
| BEA 2180 BR 100 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 4 | 0.497 Score on a scale | Standard Error 0.049 |
| BEA 2180 BR 100 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 12 | 0.486 Score on a scale | Standard Error 0.054 |
| BEA 2180 BR 100 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 24 | 0.472 Score on a scale | Standard Error 0.058 |
| BEA 2180 BR 100 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 0 | 2.0 Score on a scale | Standard Error 0.8 |
| BEA 2180 BR 200 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 4 | 0.478 Score on a scale | Standard Error 0.05 |
| BEA 2180 BR 200 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 0 | 2.0 Score on a scale | Standard Error 0.7 |
| BEA 2180 BR 200 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 12 | 0.460 Score on a scale | Standard Error 0.055 |
| BEA 2180 BR 200 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 24 | 0.502 Score on a scale | Standard Error 0.059 |
| Tiotropium Bromide 5 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 4 | 0.449 Score on a scale | Standard Error 0.048 |
| Tiotropium Bromide 5 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 0 | 2.0 Score on a scale | Standard Error 0.7 |
| Tiotropium Bromide 5 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 24 | 0.474 Score on a scale | Standard Error 0.057 |
| Tiotropium Bromide 5 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Effort Domain Score | Week 12 | 0.478 Score on a scale | Standard Error 0.053 |
Secondary
Transition Dyspnea Index - Magnitude of Task Domain Score
The transitional dyspnea index (TDI) evaluates the patient's condition related to breathlessness. The TDI includes three domains: functional impairment, magnitude of task, and magnitude of effort. The TDI domain score of magnitude of task is reported, which domain score ranges from -3 (major deterioration from baseline status; the worst score) to 3 (major improvement from baseline status; the best score).
Time frame: At week 0 (baseline), 4, 12 and 24
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 12 | 0.282 Score on a scale | Standard Error 0.053 |
| Placebo | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 0 | 2.2 Score on a scale | Standard Error 0.8 |
| Placebo | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 4 | 0.245 Score on a scale | Standard Error 0.048 |
| Placebo | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 24 | 0.322 Score on a scale | Standard Error 0.055 |
| BEA 2180 BR 50 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 4 | 0.494 Score on a scale | Standard Error 0.048 |
| BEA 2180 BR 50 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 0 | 2.2 Score on a scale | Standard Error 0.8 |
| BEA 2180 BR 50 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 24 | 0.510 Score on a scale | Standard Error 0.055 |
| BEA 2180 BR 50 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 12 | 0.494 Score on a scale | Standard Error 0.053 |
| BEA 2180 BR 100 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 0 | 2.2 Score on a scale | Standard Error 0.8 |
| BEA 2180 BR 100 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 24 | 0.513 Score on a scale | Standard Error 0.056 |
| BEA 2180 BR 100 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 4 | 0.538 Score on a scale | Standard Error 0.049 |
| BEA 2180 BR 100 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 12 | 0.587 Score on a scale | Standard Error 0.053 |
| BEA 2180 BR 200 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 0 | 2.2 Score on a scale | Standard Error 0.8 |
| BEA 2180 BR 200 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 24 | 0.514 Score on a scale | Standard Error 0.057 |
| BEA 2180 BR 200 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 12 | 0.479 Score on a scale | Standard Error 0.054 |
| BEA 2180 BR 200 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 4 | 0.571 Score on a scale | Standard Error 0.05 |
| Tiotropium Bromide 5 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 24 | 0.496 Score on a scale | Standard Error 0.055 |
| Tiotropium Bromide 5 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 0 | 2.2 Score on a scale | Standard Error 0.7 |
| Tiotropium Bromide 5 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 4 | 0.489 Score on a scale | Standard Error 0.048 |
| Tiotropium Bromide 5 Microgram (mcg) | Transition Dyspnea Index - Magnitude of Task Domain Score | Week 12 | 0.523 Score on a scale | Standard Error 0.053 |
Secondary
Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks
Trough Forced expiratory volume in one second (FEV1) response was defined as the change from baseline in trough FEV1. Trough FEV1 was defined as the mean of the two FEV1 measurements recorded at the pre-dose measurements (40 and 15 minutes before the drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler). Baseline FEV1 was pre-treatment FEV1 values measured at Day 1 of treatment period (baseline) prior to administration of the first dose of study medication, which was the mean of the measurements recorded from the pulmonary function tests taken at 40 and 15 minutes prior to drug administration at Day 1 of treatment period.
Time frame: 40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 1, 2, 4, 8, 12 and 18.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 1 | -0.014 litre | Standard Error 0.008 |
| Placebo | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 2 | -0.013 litre | Standard Error 0.009 |
| Placebo | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 4 | -0.020 litre | Standard Error 0.009 |
| Placebo | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 8 | -0.006 litre | Standard Error 0.01 |
| Placebo | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 12 | -0.010 litre | Standard Error 0.01 |
| Placebo | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 18 | -0.023 litre | Standard Error 0.01 |
| BEA 2180 BR 50 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 12 | 0.066 litre | Standard Error 0.01 |
| BEA 2180 BR 50 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 18 | 0.063 litre | Standard Error 0.01 |
| BEA 2180 BR 50 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 1 | 0.070 litre | Standard Error 0.008 |
| BEA 2180 BR 50 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 4 | 0.066 litre | Standard Error 0.009 |
| BEA 2180 BR 50 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 8 | 0.078 litre | Standard Error 0.01 |
| BEA 2180 BR 50 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 2 | 0.080 litre | Standard Error 0.009 |
| BEA 2180 BR 100 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 8 | 0.086 litre | Standard Error 0.01 |
| BEA 2180 BR 100 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 12 | 0.083 litre | Standard Error 0.01 |
| BEA 2180 BR 100 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 1 | 0.090 litre | Standard Error 0.008 |
| BEA 2180 BR 100 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 4 | 0.090 litre | Standard Error 0.009 |
| BEA 2180 BR 100 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 2 | 0.094 litre | Standard Error 0.009 |
| BEA 2180 BR 100 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 18 | 0.072 litre | Standard Error 0.01 |
| BEA 2180 BR 200 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 8 | 0.101 litre | Standard Error 0.01 |
| BEA 2180 BR 200 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 2 | 0.110 litre | Standard Error 0.009 |
| BEA 2180 BR 200 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 4 | 0.100 litre | Standard Error 0.009 |
| BEA 2180 BR 200 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 18 | 0.096 litre | Standard Error 0.01 |
| BEA 2180 BR 200 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 12 | 0.107 litre | Standard Error 0.01 |
| BEA 2180 BR 200 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 1 | 0.106 litre | Standard Error 0.009 |
| Tiotropium Bromide 5 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 12 | 0.109 litre | Standard Error 0.01 |
| Tiotropium Bromide 5 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 4 | 0.099 litre | Standard Error 0.009 |
| Tiotropium Bromide 5 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 2 | 0.105 litre | Standard Error 0.008 |
| Tiotropium Bromide 5 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 18 | 0.096 litre | Standard Error 0.01 |
| Tiotropium Bromide 5 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 8 | 0.104 litre | Standard Error 0.01 |
| Tiotropium Bromide 5 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks | Week 1 | 0.097 litre | Standard Error 0.008 |
Secondary
Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5
Trough Forced expiratory volume in one second (FEV1) response on Day 3 and 5 are reported, for which the FEV1 response is the change from baseline in trough FEV1. Trough FEV1 for respective day (Day 3 or Day 5)was defined as the mean of the two FEV1 measurements recorded at the pre-dose measurements (40 and 15 minutes before the drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler) at that day. Baseline FEV1 was pre-treatment FEV1 values measured at Day 1 of treatment period (baseline) prior to administration of the first dose of study medication, which was the mean of the measurements recorded from the pulmonary function tests taken at 40 and 15 minutes prior to drug administration at Day 1 of treatment period.
Time frame: 40 minutes (min) and 15 min before drug administration at Day 1 (baseline) and Day 3 and 5 of treatment period.
Population: Sub-study set (SUB): This patient set includes all patients in the full analysis set that were enrolled in the sub-study (at selected sites only) and have acceptable non-missing forced expiratory volume in one second (FEV1) data from 2 additional visits on Day 3 and 5.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5 | Day 3 | 0.008 liter | Standard Error 0.026 |
| Placebo | Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5 | Day 5 | 0.012 liter | Standard Error 0.023 |
| BEA 2180 BR 50 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5 | Day 3 | 0.060 liter | Standard Error 0.025 |
| BEA 2180 BR 50 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5 | Day 5 | 0.041 liter | Standard Error 0.023 |
| BEA 2180 BR 100 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5 | Day 3 | 0.101 liter | Standard Error 0.025 |
| BEA 2180 BR 100 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5 | Day 5 | 0.095 liter | Standard Error 0.023 |
| BEA 2180 BR 200 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5 | Day 5 | 0.115 liter | Standard Error 0.24 |
| BEA 2180 BR 200 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5 | Day 3 | 0.124 liter | Standard Error 0.026 |
| Tiotropium Bromide 5 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5 | Day 3 | 0.103 liter | Standard Error 0.026 |
| Tiotropium Bromide 5 Microgram (mcg) | Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5 | Day 5 | 0.118 liter | Standard Error 0.024 |
Secondary
Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks
Trough forced vital capacity (FVC) response was defined as the change from baseline in trough FVC. Trough FVC was defined as the mean of the two FVC measurements recorded at the pre-dose measurements (40 and 15 minutes before drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler), which were obtained through spirometry at the same time points as for forced expiratory volume in one second. Baseline FVC was the mean of the two measurements of FVC taken at 40 and 15 minutes before drug administration at Day 1 of treatment period.
Time frame: 40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 1, 2, 4, 8, 12, 18, and 24.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 1 | -0.002 litre | Standard Error 0.015 |
| Placebo | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 24 | -0.044 litre | Standard Error 0.019 |
| Placebo | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 18 | -0.023 litre | Standard Error 0.018 |
| Placebo | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 4 | -0.022 litre | Standard Error 0.016 |
| Placebo | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 2 | -0.002 litre | Standard Error 0.016 |
| Placebo | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 8 | 0.006 litre | Standard Error 0.018 |
| Placebo | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 12 | 0.001 litre | Standard Error 0.018 |
| BEA 2180 BR 50 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 12 | 0.121 litre | Standard Error 0.018 |
| BEA 2180 BR 50 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 8 | 0.148 litre | Standard Error 0.018 |
| BEA 2180 BR 50 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 2 | 0.166 litre | Standard Error 0.016 |
| BEA 2180 BR 50 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 1 | 0.146 litre | Standard Error 0.015 |
| BEA 2180 BR 50 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 18 | 0.117 litre | Standard Error 0.018 |
| BEA 2180 BR 50 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 4 | 0.132 litre | Standard Error 0.016 |
| BEA 2180 BR 50 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 24 | 0.081 litre | Standard Error 0.019 |
| BEA 2180 BR 100 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 8 | 0.166 litre | Standard Error 0.018 |
| BEA 2180 BR 100 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 1 | 0.172 litre | Standard Error 0.016 |
| BEA 2180 BR 100 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 2 | 0.177 litre | Standard Error 0.016 |
| BEA 2180 BR 100 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 4 | 0.157 litre | Standard Error 0.016 |
| BEA 2180 BR 100 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 12 | 0.155 litre | Standard Error 0.018 |
| BEA 2180 BR 100 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 18 | 0.131 litre | Standard Error 0.018 |
| BEA 2180 BR 100 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 24 | 0.104 litre | Standard Error 0.019 |
| BEA 2180 BR 200 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 4 | 0.156 litre | Standard Error 0.017 |
| BEA 2180 BR 200 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 12 | 0.171 litre | Standard Error 0.018 |
| BEA 2180 BR 200 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 2 | 0.186 litre | Standard Error 0.017 |
| BEA 2180 BR 200 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 24 | 0.132 litre | Standard Error 0.02 |
| BEA 2180 BR 200 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 18 | 0.153 litre | Standard Error 0.019 |
| BEA 2180 BR 200 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 1 | 0.186 litre | Standard Error 0.016 |
| BEA 2180 BR 200 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 8 | 0.173 litre | Standard Error 0.018 |
| Tiotropium Bromide 5 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 4 | 0.169 litre | Standard Error 0.016 |
| Tiotropium Bromide 5 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 24 | 0.146 litre | Standard Error 0.019 |
| Tiotropium Bromide 5 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 18 | 0.146 litre | Standard Error 0.018 |
| Tiotropium Bromide 5 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 12 | 0.178 litre | Standard Error 0.018 |
| Tiotropium Bromide 5 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 2 | 0.188 litre | Standard Error 0.016 |
| Tiotropium Bromide 5 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 1 | 0.174 litre | Standard Error 0.015 |
| Tiotropium Bromide 5 Microgram (mcg) | Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks | Week 8 | 0.177 litre | Standard Error 0.018 |
Secondary
Weekly Mean Evening Peak Expiratory Flow Rate (PEFR)
The patient recorded twice daily peak flow measurements with an electronic peak flow meter throughout the entire evaluation period. Morning measurements were performed immediately upon arising after the patient had cleared out mucus, prior to administration of trial and/or rescue medication. The evening measurements were performed at bedtime. The weekly mean of evening peak expiratory flow rate (PEFR) is reported.
Time frame: Assessed at bed time per day during 24 weeks with weekly mean values reporting.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 8 | 166.98 litres/minute | Standard Error 1.975 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 15 | 162.77 litres/minute | Standard Error 2.193 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 11 | 163.02 litres/minute | Standard Error 2.122 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 23 | 160.75 litres/minute | Standard Error 2.316 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 14 | 162.72 litres/minute | Standard Error 2.168 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 12 | 163.84 litres/minute | Standard Error 2.169 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 13 | 163.95 litres/minute | Standard Error 2.162 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 3 | 171.85 litres/minute | Standard Error 1.761 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 22 | 160.32 litres/minute | Standard Error 2.309 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 4 | 170.91 litres/minute | Standard Error 1.858 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 21 | 161.13 litres/minute | Standard Error 2.307 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 5 | 172.33 litres/minute | Standard Error 1.921 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 24 | 159.69 litres/minute | Standard Error 2.356 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 20 | 160.54 litres/minute | Standard Error 2.322 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 6 | 169.29 litres/minute | Standard Error 2.009 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 19 | 161.70 litres/minute | Standard Error 2.229 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 7 | 168.10 litres/minute | Standard Error 1.989 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 18 | 161.66 litres/minute | Standard Error 2.206 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 2 | 173.18 litres/minute | Standard Error 1.694 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 17 | 161.12 litres/minute | Standard Error 2.199 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 9 | 165.67 litres/minute | Standard Error 2.033 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 16 | 161.50 litres/minute | Standard Error 2.227 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 10 | 164.15 litres/minute | Standard Error 2.067 |
| Placebo | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 1 | 173.64 litres/minute | Standard Error 1.467 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 8 | 183.69 litres/minute | Standard Error 1.97 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 2 | 187.16 litres/minute | Standard Error 1.69 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 19 | 177.34 litres/minute | Standard Error 2.223 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 11 | 182.05 litres/minute | Standard Error 2.117 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 17 | 179.50 litres/minute | Standard Error 2.193 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 14 | 179.23 litres/minute | Standard Error 2.162 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 6 | 183.97 litres/minute | Standard Error 2.004 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 16 | 179.17 litres/minute | Standard Error 2.22 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 12 | 180.46 litres/minute | Standard Error 2.163 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 22 | 174.78 litres/minute | Standard Error 2.302 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 13 | 180.80 litres/minute | Standard Error 2.156 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 10 | 181.90 litres/minute | Standard Error 2.062 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 7 | 183.82 litres/minute | Standard Error 1.984 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 3 | 187.14 litres/minute | Standard Error 1.756 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 1 | 186.40 litres/minute | Standard Error 1.463 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 23 | 174.37 litres/minute | Standard Error 2.31 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 21 | 175.87 litres/minute | Standard Error 2.3 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 18 | 177.88 litres/minute | Standard Error 2.2 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 4 | 186.96 litres/minute | Standard Error 1.853 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 24 | 172.72 litres/minute | Standard Error 2.349 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 9 | 182.98 litres/minute | Standard Error 2.028 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 20 | 177.50 litres/minute | Standard Error 2.316 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 15 | 178.86 litres/minute | Standard Error 2.187 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 5 | 186.03 litres/minute | Standard Error 1.915 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 6 | 185.32 litres/minute | Standard Error 2.009 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 1 | 186.37 litres/minute | Standard Error 1.467 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 2 | 185.96 litres/minute | Standard Error 1.694 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 3 | 183.77 litres/minute | Standard Error 1.761 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 4 | 184.33 litres/minute | Standard Error 1.858 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 5 | 186.84 litres/minute | Standard Error 1.92 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 7 | 184.57 litres/minute | Standard Error 1.989 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 8 | 182.81 litres/minute | Standard Error 1.975 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 9 | 181.88 litres/minute | Standard Error 2.033 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 10 | 179.46 litres/minute | Standard Error 2.067 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 11 | 179.36 litres/minute | Standard Error 2.122 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 12 | 179.65 litres/minute | Standard Error 2.169 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 13 | 178.40 litres/minute | Standard Error 2.162 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 14 | 177.70 litres/minute | Standard Error 2.168 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 15 | 177.33 litres/minute | Standard Error 2.193 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 16 | 177.30 litres/minute | Standard Error 2.226 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 17 | 177.51 litres/minute | Standard Error 2.198 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 18 | 176.28 litres/minute | Standard Error 2.206 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 19 | 177.78 litres/minute | Standard Error 2.229 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 20 | 177.23 litres/minute | Standard Error 2.322 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 21 | 176.16 litres/minute | Standard Error 2.306 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 22 | 175.23 litres/minute | Standard Error 2.308 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 23 | 176.10 litres/minute | Standard Error 2.316 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 24 | 176.20 litres/minute | Standard Error 2.356 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 9 | 184.21 litres/minute | Standard Error 2.136 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 1 | 187.31 litres/minute | Standard Error 1.542 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 20 | 179.20 litres/minute | Standard Error 2.441 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 7 | 182.39 litres/minute | Standard Error 2.09 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 4 | 187.11 litres/minute | Standard Error 1.952 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 23 | 177.54 litres/minute | Standard Error 2.434 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 6 | 184.51 litres/minute | Standard Error 2.11 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 21 | 178.87 litres/minute | Standard Error 2.424 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 18 | 178.92 litres/minute | Standard Error 2.321 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 3 | 187.41 litres/minute | Standard Error 1.851 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 15 | 181.66 litres/minute | Standard Error 2.304 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 8 | 182.01 litres/minute | Standard Error 2.076 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 24 | 179.04 litres/minute | Standard Error 2.475 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 12 | 180.52 litres/minute | Standard Error 2.281 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 22 | 177.71 litres/minute | Standard Error 2.424 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 13 | 181.12 litres/minute | Standard Error 2.27 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 17 | 178.95 litres/minute | Standard Error 2.314 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 2 | 187.16 litres/minute | Standard Error 1.782 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 11 | 182.54 litres/minute | Standard Error 2.227 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 19 | 178.64 litres/minute | Standard Error 2.342 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 14 | 181.26 litres/minute | Standard Error 2.278 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 16 | 180.18 litres/minute | Standard Error 2.342 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 5 | 185.67 litres/minute | Standard Error 2.017 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 10 | 182.53 litres/minute | Standard Error 2.17 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 11 | 181.58 litres/minute | Standard Error 2.092 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 15 | 182.12 litres/minute | Standard Error 2.162 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 9 | 183.38 litres/minute | Standard Error 2.004 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 1 | 187.13 litres/minute | Standard Error 1.446 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 16 | 180.76 litres/minute | Standard Error 2.194 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 8 | 181.66 litres/minute | Standard Error 1.947 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 17 | 180.40 litres/minute | Standard Error 2.167 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 7 | 183.80 litres/minute | Standard Error 1.96 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 18 | 179.47 litres/minute | Standard Error 2.174 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 6 | 184.34 litres/minute | Standard Error 1.98 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 5 | 185.02 litres/minute | Standard Error 1.893 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 23 | 178.20 litres/minute | Standard Error 2.283 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 19 | 179.98 litres/minute | Standard Error 2.197 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 4 | 185.23 litres/minute | Standard Error 1.831 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 20 | 180.70 litres/minute | Standard Error 2.288 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 3 | 185.61 litres/minute | Standard Error 1.735 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 21 | 179.66 litres/minute | Standard Error 2.273 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 2 | 185.79 litres/minute | Standard Error 1.669 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 24 | 178.21 litres/minute | Standard Error 2.322 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 12 | 181.09 litres/minute | Standard Error 2.138 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 13 | 183.50 litres/minute | Standard Error 2.131 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 22 | 178.98 litres/minute | Standard Error 2.275 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 14 | 183.27 litres/minute | Standard Error 2.137 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) | Week 10 | 182.12 litres/minute | Standard Error 2.038 |
Secondary
Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol])
The patient recorded the number of occasions salbutamol (albuterol) Metered Dose Inhaler (MDI) was used each day and night during the entire evaluation period. The weekly mean number of occasions of rescue therapy used per day (PRN salbutamol \[albuterol\]) is reported.
Time frame: Assessed once per day during 24 weeks with weekly mean values reporting.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 11 | 2.693 Metered Dose Inhaler use per day | Standard Error 0.092 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 1 | 2.514 Metered Dose Inhaler use per day | Standard Error 0.075 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 6 | 2.629 Metered Dose Inhaler use per day | Standard Error 0.088 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 13 | 2.645 Metered Dose Inhaler use per day | Standard Error 0.091 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 3 | 2.509 Metered Dose Inhaler use per day | Standard Error 0.081 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 17 | 2.738 Metered Dose Inhaler use per day | Standard Error 0.096 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 2 | 2.524 Metered Dose Inhaler use per day | Standard Error 0.079 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 7 | 2.656 Metered Dose Inhaler use per day | Standard Error 0.088 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 23 | 2.675 Metered Dose Inhaler use per day | Standard Error 0.098 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 12 | 2.678 Metered Dose Inhaler use per day | Standard Error 0.091 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 4 | 2.498 Metered Dose Inhaler use per day | Standard Error 0.081 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 19 | 2.706 Metered Dose Inhaler use per day | Standard Error 0.099 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 8 | 2.612 Metered Dose Inhaler use per day | Standard Error 0.089 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 15 | 2.712 Metered Dose Inhaler use per day | Standard Error 0.094 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 5 | 2.548 Metered Dose Inhaler use per day | Standard Error 0.086 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 24 | 2.672 Metered Dose Inhaler use per day | Standard Error 0.1 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 22 | 2.704 Metered Dose Inhaler use per day | Standard Error 0.098 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 9 | 2.617 Metered Dose Inhaler use per day | Standard Error 0.088 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 18 | 2.756 Metered Dose Inhaler use per day | Standard Error 0.097 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 21 | 2.706 Metered Dose Inhaler use per day | Standard Error 0.098 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 16 | 2.732 Metered Dose Inhaler use per day | Standard Error 0.095 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 20 | 2.670 Metered Dose Inhaler use per day | Standard Error 0.101 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 10 | 2.623 Metered Dose Inhaler use per day | Standard Error 0.09 |
| Placebo | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 14 | 2.655 Metered Dose Inhaler use per day | Standard Error 0.091 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 10 | 2.062 Metered Dose Inhaler use per day | Standard Error 0.09 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 1 | 1.964 Metered Dose Inhaler use per day | Standard Error 0.075 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 11 | 2.136 Metered Dose Inhaler use per day | Standard Error 0.092 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 14 | 2.131 Metered Dose Inhaler use per day | Standard Error 0.091 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 12 | 2.127 Metered Dose Inhaler use per day | Standard Error 0.091 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 5 | 2.040 Metered Dose Inhaler use per day | Standard Error 0.085 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 3 | 1.960 Metered Dose Inhaler use per day | Standard Error 0.081 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 13 | 2.074 Metered Dose Inhaler use per day | Standard Error 0.091 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 23 | 2.056 Metered Dose Inhaler use per day | Standard Error 0.098 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 4 | 1.977 Metered Dose Inhaler use per day | Standard Error 0.081 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 24 | 2.114 Metered Dose Inhaler use per day | Standard Error 0.1 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 21 | 2.103 Metered Dose Inhaler use per day | Standard Error 0.098 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 17 | 2.060 Metered Dose Inhaler use per day | Standard Error 0.096 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 6 | 2.048 Metered Dose Inhaler use per day | Standard Error 0.088 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 20 | 2.084 Metered Dose Inhaler use per day | Standard Error 0.101 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 7 | 2.042 Metered Dose Inhaler use per day | Standard Error 0.088 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 18 | 2.074 Metered Dose Inhaler use per day | Standard Error 0.097 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 2 | 1.985 Metered Dose Inhaler use per day | Standard Error 0.079 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 8 | 2.007 Metered Dose Inhaler use per day | Standard Error 0.088 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 16 | 2.081 Metered Dose Inhaler use per day | Standard Error 0.095 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 9 | 2.026 Metered Dose Inhaler use per day | Standard Error 0.088 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 22 | 2.124 Metered Dose Inhaler use per day | Standard Error 0.098 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 15 | 2.148 Metered Dose Inhaler use per day | Standard Error 0.094 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 19 | 2.105 Metered Dose Inhaler use per day | Standard Error 0.099 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 17 | 2.111 Metered Dose Inhaler use per day | Standard Error 0.097 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 20 | 2.149 Metered Dose Inhaler use per day | Standard Error 0.102 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 21 | 2.116 Metered Dose Inhaler use per day | Standard Error 0.099 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 22 | 2.119 Metered Dose Inhaler use per day | Standard Error 0.099 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 23 | 2.094 Metered Dose Inhaler use per day | Standard Error 0.099 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 24 | 2.116 Metered Dose Inhaler use per day | Standard Error 0.101 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 5 | 2.012 Metered Dose Inhaler use per day | Standard Error 0.086 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 6 | 2.041 Metered Dose Inhaler use per day | Standard Error 0.088 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 7 | 2.039 Metered Dose Inhaler use per day | Standard Error 0.088 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 8 | 2.010 Metered Dose Inhaler use per day | Standard Error 0.089 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 2 | 2.044 Metered Dose Inhaler use per day | Standard Error 0.08 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 9 | 1.981 Metered Dose Inhaler use per day | Standard Error 0.089 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 10 | 2.013 Metered Dose Inhaler use per day | Standard Error 0.091 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 11 | 2.020 Metered Dose Inhaler use per day | Standard Error 0.093 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 12 | 2.011 Metered Dose Inhaler use per day | Standard Error 0.092 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 13 | 2.108 Metered Dose Inhaler use per day | Standard Error 0.092 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 3 | 2.037 Metered Dose Inhaler use per day | Standard Error 0.081 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 14 | 2.161 Metered Dose Inhaler use per day | Standard Error 0.092 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 15 | 2.127 Metered Dose Inhaler use per day | Standard Error 0.095 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 1 | 1.972 Metered Dose Inhaler use per day | Standard Error 0.076 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 16 | 2.090 Metered Dose Inhaler use per day | Standard Error 0.096 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 18 | 2.078 Metered Dose Inhaler use per day | Standard Error 0.098 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 4 | 2.017 Metered Dose Inhaler use per day | Standard Error 0.082 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 19 | 2.083 Metered Dose Inhaler use per day | Standard Error 0.1 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 2 | 1.803 Metered Dose Inhaler use per day | Standard Error 0.082 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 19 | 1.896 Metered Dose Inhaler use per day | Standard Error 0.103 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 15 | 1.859 Metered Dose Inhaler use per day | Standard Error 0.098 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 1 | 1.790 Metered Dose Inhaler use per day | Standard Error 0.078 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 9 | 1.834 Metered Dose Inhaler use per day | Standard Error 0.092 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 8 | 1.877 Metered Dose Inhaler use per day | Standard Error 0.092 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 20 | 1.975 Metered Dose Inhaler use per day | Standard Error 0.105 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 16 | 1.906 Metered Dose Inhaler use per day | Standard Error 0.099 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 7 | 1.851 Metered Dose Inhaler use per day | Standard Error 0.091 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 6 | 1.789 Metered Dose Inhaler use per day | Standard Error 0.091 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 5 | 1.768 Metered Dose Inhaler use per day | Standard Error 0.089 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 24 | 1.961 Metered Dose Inhaler use per day | Standard Error 0.104 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 17 | 1.899 Metered Dose Inhaler use per day | Standard Error 0.1 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 23 | 1.959 Metered Dose Inhaler use per day | Standard Error 0.102 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 22 | 1.928 Metered Dose Inhaler use per day | Standard Error 0.102 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 21 | 1.928 Metered Dose Inhaler use per day | Standard Error 0.102 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 13 | 1.844 Metered Dose Inhaler use per day | Standard Error 0.094 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 4 | 1.885 Metered Dose Inhaler use per day | Standard Error 0.085 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 12 | 1.899 Metered Dose Inhaler use per day | Standard Error 0.095 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 11 | 1.872 Metered Dose Inhaler use per day | Standard Error 0.096 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 18 | 1.872 Metered Dose Inhaler use per day | Standard Error 0.1 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 14 | 1.844 Metered Dose Inhaler use per day | Standard Error 0.095 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 3 | 1.835 Metered Dose Inhaler use per day | Standard Error 0.084 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 10 | 1.838 Metered Dose Inhaler use per day | Standard Error 0.093 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 15 | 2.141 Metered Dose Inhaler use per day | Standard Error 0.093 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 1 | 2.084 Metered Dose Inhaler use per day | Standard Error 0.075 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 2 | 2.109 Metered Dose Inhaler use per day | Standard Error 0.079 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 3 | 2.093 Metered Dose Inhaler use per day | Standard Error 0.08 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 4 | 2.118 Metered Dose Inhaler use per day | Standard Error 0.081 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 5 | 2.106 Metered Dose Inhaler use per day | Standard Error 0.085 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 6 | 2.116 Metered Dose Inhaler use per day | Standard Error 0.087 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 7 | 2.122 Metered Dose Inhaler use per day | Standard Error 0.087 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 8 | 2.129 Metered Dose Inhaler use per day | Standard Error 0.088 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 9 | 2.094 Metered Dose Inhaler use per day | Standard Error 0.088 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 10 | 2.137 Metered Dose Inhaler use per day | Standard Error 0.089 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 11 | 2.154 Metered Dose Inhaler use per day | Standard Error 0.091 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 12 | 2.122 Metered Dose Inhaler use per day | Standard Error 0.091 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 13 | 2.112 Metered Dose Inhaler use per day | Standard Error 0.09 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 14 | 2.063 Metered Dose Inhaler use per day | Standard Error 0.091 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 23 | 2.138 Metered Dose Inhaler use per day | Standard Error 0.097 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 16 | 2.143 Metered Dose Inhaler use per day | Standard Error 0.094 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 17 | 2.153 Metered Dose Inhaler use per day | Standard Error 0.096 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 18 | 2.146 Metered Dose Inhaler use per day | Standard Error 0.096 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 19 | 2.154 Metered Dose Inhaler use per day | Standard Error 0.098 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 20 | 2.180 Metered Dose Inhaler use per day | Standard Error 0.1 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 21 | 2.156 Metered Dose Inhaler use per day | Standard Error 0.098 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 22 | 2.168 Metered Dose Inhaler use per day | Standard Error 0.098 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) | Week 24 | 2.148 Metered Dose Inhaler use per day | Standard Error 0.099 |
Secondary
Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR)
The patient recorded twice daily peak flow measurements with an electronic peak flow meter throughout the entire evaluation period. Morning measurements were performed immediately upon arising after the patient had cleared out mucus, prior to administration of trial and/or rescue medication. The evening measurements were performed at bedtime. The weekly mean morning peak expiratory flow rate (PEFR) is reported.
Time frame: Assessed before drug administration per day during 24 weeks with weekly mean values reporting.
Population: The full analysis set (FAS) was defined as all patients in treated set with at least baseline Forced expiratory volume in one second (FEV1) data and at least one acceptable post-treatment trough FEV1 measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 7 | 160.30 litres/minute | Standard Error 2.033 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 2 | 164.34 litres/minute | Standard Error 1.917 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 3 | 164.53 litres/minute | Standard Error 1.957 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 4 | 163.82 litres/minute | Standard Error 2.006 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 5 | 163.00 litres/minute | Standard Error 1.983 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 6 | 162.31 litres/minute | Standard Error 2.058 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 1 | 163.41 litres/minute | Standard Error 1.629 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 8 | 159.83 litres/minute | Standard Error 2.085 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 9 | 159.89 litres/minute | Standard Error 2.156 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 10 | 158.74 litres/minute | Standard Error 2.126 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 11 | 157.98 litres/minute | Standard Error 2.165 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 12 | 156.91 litres/minute | Standard Error 2.192 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 13 | 156.22 litres/minute | Standard Error 2.093 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 14 | 156.66 litres/minute | Standard Error 2.165 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 15 | 156.78 litres/minute | Standard Error 2.196 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 16 | 155.76 litres/minute | Standard Error 2.206 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 17 | 154.59 litres/minute | Standard Error 2.267 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 18 | 154.04 litres/minute | Standard Error 2.248 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 19 | 154.37 litres/minute | Standard Error 2.263 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 20 | 154.77 litres/minute | Standard Error 2.291 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 21 | 153.47 litres/minute | Standard Error 2.276 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 22 | 153.85 litres/minute | Standard Error 2.267 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 23 | 153.41 litres/minute | Standard Error 2.303 |
| Placebo | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 24 | 153.15 litres/minute | Standard Error 2.311 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 1 | 177.03 litres/minute | Standard Error 1.641 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 21 | 169.30 litres/minute | Standard Error 2.293 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 22 | 167.60 litres/minute | Standard Error 2.284 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 11 | 173.45 litres/minute | Standard Error 2.181 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 18 | 169.36 litres/minute | Standard Error 2.266 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 7 | 175.71 litres/minute | Standard Error 2.049 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 3 | 177.19 litres/minute | Standard Error 1.972 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 20 | 169.31 litres/minute | Standard Error 2.309 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 12 | 174.72 litres/minute | Standard Error 2.209 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 9 | 175.74 litres/minute | Standard Error 2.171 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 19 | 169.24 litres/minute | Standard Error 2.28 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 23 | 167.38 litres/minute | Standard Error 2.32 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 6 | 176.26 litres/minute | Standard Error 2.073 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 13 | 173.59 litres/minute | Standard Error 2.109 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 17 | 171.32 litres/minute | Standard Error 2.285 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 5 | 176.16 litres/minute | Standard Error 1.998 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 2 | 177.64 litres/minute | Standard Error 1.932 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 4 | 174.99 litres/minute | Standard Error 2.021 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 14 | 172.29 litres/minute | Standard Error 2.181 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 16 | 170.92 litres/minute | Standard Error 2.223 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 10 | 173.63 litres/minute | Standard Error 2.142 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 24 | 167.08 litres/minute | Standard Error 2.329 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 8 | 173.99 litres/minute | Standard Error 2.101 |
| BEA 2180 BR 50 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 15 | 171.12 litres/minute | Standard Error 2.213 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 20 | 169.84 litres/minute | Standard Error 2.332 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 8 | 173.95 litres/minute | Standard Error 2.123 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 16 | 169.26 litres/minute | Standard Error 2.246 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 23 | 167.26 litres/minute | Standard Error 2.345 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 17 | 169.53 litres/minute | Standard Error 2.309 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 19 | 170.45 litres/minute | Standard Error 2.304 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 4 | 176.37 litres/minute | Standard Error 2.042 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 18 | 168.95 litres/minute | Standard Error 2.289 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 9 | 172.84 litres/minute | Standard Error 2.194 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 5 | 176.90 litres/minute | Standard Error 2.019 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 24 | 165.87 litres/minute | Standard Error 2.353 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 10 | 171.24 litres/minute | Standard Error 2.164 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 21 | 169.12 litres/minute | Standard Error 2.317 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 3 | 177.38 litres/minute | Standard Error 1.993 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 11 | 169.92 litres/minute | Standard Error 2.204 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 22 | 169.29 litres/minute | Standard Error 2.308 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 12 | 169.90 litres/minute | Standard Error 2.232 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 7 | 174.35 litres/minute | Standard Error 2.07 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 2 | 175.82 litres/minute | Standard Error 1.952 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 13 | 169.96 litres/minute | Standard Error 2.131 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 15 | 168.69 litres/minute | Standard Error 2.236 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 14 | 168.51 litres/minute | Standard Error 2.203 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 6 | 175.31 litres/minute | Standard Error 2.095 |
| BEA 2180 BR 100 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 1 | 176.20 litres/minute | Standard Error 1.658 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 5 | 178.29 litres/minute | Standard Error 2.094 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 6 | 177.59 litres/minute | Standard Error 2.172 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 7 | 175.85 litres/minute | Standard Error 2.147 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 21 | 175.43 litres/minute | Standard Error 2.404 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 8 | 176.41 litres/minute | Standard Error 2.201 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 9 | 177.35 litres/minute | Standard Error 2.274 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 10 | 176.14 litres/minute | Standard Error 2.242 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 11 | 174.05 litres/minute | Standard Error 2.283 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 12 | 175.40 litres/minute | Standard Error 2.316 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 22 | 175.12 litres/minute | Standard Error 2.393 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 13 | 175.51 litres/minute | Standard Error 2.211 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 14 | 175.65 litres/minute | Standard Error 2.283 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 24 | 176.36 litres/minute | Standard Error 2.441 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 15 | 175.01 litres/minute | Standard Error 2.318 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 16 | 174.07 litres/minute | Standard Error 2.33 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 17 | 174.89 litres/minute | Standard Error 2.396 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 23 | 174.30 litres/minute | Standard Error 2.43 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 18 | 173.59 litres/minute | Standard Error 2.376 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 19 | 175.29 litres/minute | Standard Error 2.389 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 1 | 179.46 litres/minute | Standard Error 1.718 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 2 | 179.24 litres/minute | Standard Error 2.023 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 20 | 174.81 litres/minute | Standard Error 2.42 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 3 | 178.94 litres/minute | Standard Error 2.067 |
| BEA 2180 BR 200 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 4 | 178.06 litres/minute | Standard Error 2.118 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 16 | 174.23 litres/minute | Standard Error 2.205 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 15 | 174.03 litres/minute | Standard Error 2.195 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 14 | 174.86 litres/minute | Standard Error 2.163 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 4 | 175.17 litres/minute | Standard Error 2.004 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 1 | 177.54 litres/minute | Standard Error 1.628 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 22 | 171.93 litres/minute | Standard Error 2.265 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 13 | 175.97 litres/minute | Standard Error 2.091 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 12 | 174.63 litres/minute | Standard Error 2.191 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 8 | 174.71 litres/minute | Standard Error 2.084 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 2 | 176.46 litres/minute | Standard Error 1.916 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 7 | 175.50 litres/minute | Standard Error 2.032 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 11 | 174.82 litres/minute | Standard Error 2.163 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 10 | 174.71 litres/minute | Standard Error 2.125 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 6 | 175.09 litres/minute | Standard Error 2.056 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 3 | 175.49 litres/minute | Standard Error 1.956 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 20 | 173.31 litres/minute | Standard Error 2.289 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 9 | 174.75 litres/minute | Standard Error 2.154 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 21 | 172.77 litres/minute | Standard Error 2.274 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 23 | 171.13 litres/minute | Standard Error 2.302 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 18 | 171.90 litres/minute | Standard Error 2.246 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 17 | 174.04 litres/minute | Standard Error 2.266 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 5 | 176.32 litres/minute | Standard Error 1.982 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 19 | 172.92 litres/minute | Standard Error 2.261 |
| Tiotropium Bromide 5 Microgram (mcg) | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) | Week 24 | 171.53 litres/minute | Standard Error 2.31 |