Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The primary objective of this study is to evaluate long-term safety and patient acceptability of COMBIVENT RESPIMAT Inhalation Spray as compared to the COMBIVENT Inhalation Aerosol Chlorofluorocarbon-Metered Dose Inhaler (CFC-MDI) and the free combination of ATROVENT Hydrofluoroalkane (HFA) and albuterol Hydrofluoroalkane (HFA) inhalation aerosols.
Interventions
DRUGCombivent CFC-MDI
36/206 mcg Four times a day (QID)
DRUGCombivent Respimat 20/100 mcg
Open label randomized parallel
DRUGAtrovent HFA 42 mcg + Albuterol HFA 200 mcg
Open label randomized parallel
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. All patients must sign an informed consent consistent with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines prior to participation in the trial. 2. Male or female patients 40 years of age or older. 3. Patients must be current or ex-smokers with a smoking history of 10 pack-years. (Patients who have never smoked cigarettes must be excluded) Pack Years = Number of cigarettes/day x years of smoking 20 cigarettes/pack 4. All patients must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (P95-4381), and must meet the following spirometric criteria at Visit 1:Relatively stable, moderate to severe airway obstruction with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) \< 80% of predicted normal and FEV1/Forced Vital Capacity (FVC) \< 70%. Spirometry should be done at baseline and approximately 1/2 hour following 4 inhalations of albuterol. Predicted normal values will be calculated according to European Coal and Steel Community (ECSC), European Community for Coal and Steel (ECCS), (R94-1408). For Height measured in inches Males: FEV1 predicted (L) = 4.30 x \[height (inches) / 39.37\]-0.029 x age (yrs) - 2.49 Females: FEV1 predicted (L) = 3.95 x \[height (inches) / 39.37\]-0.025 x age (yrs) - 2.60 For Height measured in meters Males: FEV1 predicted (L) = 4.30 x \[height (meters)\] - 0.029 x age (years) -2.49 Females: FEV1 predicted (L) = 3.95 x \[height (meters)\] - 0.025 x age (years) - 2.60 5. Patients must be able to perform all study related procedures and maintain study records 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 and from a metered dose inhaler (MDI).
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's ability to participate in the study. 2. Patients with a recent history (i.e., one year or less) of myocardial infarction. 3. Patients who have been hospitalized or being treated for heart failure within the past year. 4. Patients with clinically unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy within the past year. 5. Patients with a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with fully cured squamous cell or treated basal cell carcinoma are allowed). 6. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis. 7. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of a thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1. 8. Patients with a current diagnosis of asthma. 9. Patients with a history of significant alcohol or drug abuse. 10. Patients with known active tuberculosis. 11. Patients using beta blocker medications are excluded. Cardioselective beta blockers are allowed with caution. Beta blocker eye medications for treatment of non-narrow angle glaucoma are allowed. 12. Patients who regularly use daytime oxygen therapy for more than 1 hour per day Continuous Positive Airway Pressure (CPAP for sleep apnea is allowed). 13. Patients using oral corticosteroid medication at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day, except as required for treatment of exacerbation during the study. 14. Pregnant or nursing women. 15. Women of childbearing potential not using a medically approved means of contraception (i.e., oral or injectable contraceptives, intrauterine devices or diaphragm with spermicide, or transdermal hormonal patches). Abstinence will not be accepted as a medically approved means of contraception. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years. 16. Patients with known hypersensitivity to anticholinergic drugs, any other component of the ipratropium bromide/albuterol RESPIMAT solution including Benzalkonium chloride (BAC) and Ethylenediaminetetraacetic acid (EDTA) or the ipratropium bromide/albuterol Chlorofluorocarbons (CFC) MDI or Hydrofluoroalkane (HFA) components. 17. Previous participation in this study. (The patient cannot re-enroll into this study.) 18. Patients who are currently participating in another interventional study. 19. Patients who have taken an investigational drug within 1 month or 6 half lives (whichever is greater) prior to screening. 20. Patients currently in any pulmonary rehabilitation program or scheduled to participate in any such program during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 | 48 weeks | Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 | 12 weeks | Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied). |
| Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 | 24 weeks | Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied). |
| Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 | 36 weeks | Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied). |
| Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0 | 0 weeks | Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied). |
| Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 | 3 weeks | Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied). |
| Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 | 12 weeks | Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied). |
| Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 | 24 weeks | Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied). |
| Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 | 36 weeks | Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied). |
| Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 | 48 weeks | Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied). |
| Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0 | 0 weeks | CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited). |
| Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3 | 3 weeks | CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited). |
| Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12 | 12 weeks | CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited). |
| Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24 | 24 weeks | CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited). |
| Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36 | 36 weeks | CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited). |
| Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48 | 48 weeks | CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited). |
| Physician's Global Evaluation at Week 0 | 0 weeks | Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8). |
| Physician's Global Evaluation at Week 3 | 3 weeks | Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8). |
| Physician's Global Evaluation at Week 12 | 12 weeks | Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8). |
| Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 | 3 weeks | Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied). |
| Physician's Global Evaluation at Week 36 | 36 weeks | Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8). |
| Physician's Global Evaluation at Week 48 | 48 weeks | Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8). |
| Change From Baseline in FEV1 at Day 1 | baseline, day 1 | Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose on test day 1. |
| Change From Baseline in FEV1 at Week 12 | baseline, 12 weeks | Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 12 |
| Change From Baseline in FEV1 at Week 24 | baseline, 24 weeks | Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 24 |
| Change From Baseline in FEV1 at Week 48 | baseline, 48 weeks | Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 48 |
| Change From Baseline in FVC at Day 1 | baseline, day 1 | Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose on test day 1. |
| Change From Baseline in FVC at Week 12 | baseline, 12 weeks | Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 12 |
| Change From Baseline in FVC at Week 24 | baseline, 24 weeks | Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 24 |
| Change From Baseline in FVC at Week 48 | baseline, 48 weeks | Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 48 |
| Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 0 | 0 weeks | Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 0 |
| Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3 | 3 weeks | Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 3 |
| Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12 | 12 weeks | Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 12 |
| Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24 | 24 weeks | Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 24 |
| Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36 | 36 weeks | Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 36 |
| Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48 | 48 weeks | Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 48 |
| Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 48 weeks | — |
| Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization | 48 weeks | — |
| Physician's Global Evaluation at Week 24 | 24 weeks | Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combivent Respimat ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid) | 157 |
| Combivent Inhalation Aerosol ipratropium bromide and albuterol sulfate 36/206 mcg qid | 154 |
| Atrovent + Albuterol Aerosols ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid | 154 |
| Total | 465 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 12 | 16 | 19 |
| Overall Study | Lost to Follow-up | 5 | 3 | 3 |
| Overall Study | Not treated | 0 | 2 | 3 |
| Overall Study | Other reason (not specified) | 1 | 5 | 6 |
| Overall Study | Protocol Violation | 2 | 6 | 4 |
| Overall Study | Withdrawal by Subject | 4 | 6 | 12 |
Baseline characteristics
| Characteristic | Combivent Inhalation Aerosol | Atrovent + Albuterol Aerosols | Total | Combivent Respimat |
|---|---|---|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 8.9 | 63.0 years STANDARD_DEVIATION 9.3 | 62.9 years STANDARD_DEVIATION 8.8 | 63.0 years STANDARD_DEVIATION 8.2 |
| Age, Customized >= 40 to < 65 years | 91 participants | 82 participants | 263 participants | 90 participants |
| Age, Customized >= 65 to < 75 years | 47 participants | 58 participants | 156 participants | 51 participants |
| Age, Customized >= 75 years | 16 participants | 14 participants | 46 participants | 16 participants |
| Chronic Obstructive Pulmonary Disease (COPD) Duration | 7.3 years STANDARD_DEVIATION 6.1 | 7.5 years STANDARD_DEVIATION 5.8 | 7.6 years STANDARD_DEVIATION 6.2 | 8.1 years STANDARD_DEVIATION 6.7 |
| Height | 170.6 centimeters STANDARD_DEVIATION 10.4 | 171.1 centimeters STANDARD_DEVIATION 10.4 | 170.8 centimeters STANDARD_DEVIATION 10.1 | 170.6 centimeters STANDARD_DEVIATION 9.6 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 participants | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Black / African American | 11 participants | 9 participants | 29 participants | 9 participants |
| Race/Ethnicity, Customized White | 143 participants | 144 participants | 435 participants | 148 participants |
| Sex: Female, Male Female | 70 Participants | 57 Participants | 192 Participants | 65 Participants |
| Sex: Female, Male Male | 84 Participants | 97 Participants | 273 Participants | 92 Participants |
| Smoking History Currently smokes | 93 participants | 75 participants | 242 participants | 74 participants |
| Smoking History Ex-smoker | 61 participants | 79 participants | 223 participants | 83 participants |
| Smoking History (pack years) | 53.6 pack years STANDARD_DEVIATION 29.7 | 55.6 pack years STANDARD_DEVIATION 25.4 | 54.3 pack years STANDARD_DEVIATION 26.6 | 53.6 pack years STANDARD_DEVIATION 24.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 68 / 157 | 76 / 154 | 71 / 154 |
| serious Total, serious adverse events | 23 / 157 | 20 / 154 | 25 / 154 |
Outcome results
Primary
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Time frame: 48 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 | 87.9 unit on a scale | Standard Error 1.27 |
| Combivent Inhalation Aerosol | Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 | 78.3 unit on a scale | Standard Error 1.31 |
| Atrovent + Albuterol Aerosols | Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 | 81.7 unit on a scale | Standard Error 1.37 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: <0.000195% CI: [6.02, 13.19]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.000995% CI: [2.57, 9.91]Mixed Models Analysis
Secondary
Change From Baseline in FEV1 at Day 1
Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose on test day 1.
Time frame: baseline, day 1
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Change From Baseline in FEV1 at Day 1 | 0.22 liters | Standard Error 0.015 |
| Combivent Inhalation Aerosol | Change From Baseline in FEV1 at Day 1 | 0.21 liters | Standard Error 0.015 |
| Atrovent + Albuterol Aerosols | Change From Baseline in FEV1 at Day 1 | 0.21 liters | Standard Error 0.015 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.828295% CI: [-0.036, 0.045]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.658795% CI: [-0.032, 0.05]Mixed Models Analysis
Secondary
Change From Baseline in FEV1 at Week 12
Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 12
Time frame: baseline, 12 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Change From Baseline in FEV1 at Week 12 | 0.23 liters | Standard Error 0.016 |
| Combivent Inhalation Aerosol | Change From Baseline in FEV1 at Week 12 | 0.19 liters | Standard Error 0.016 |
| Atrovent + Albuterol Aerosols | Change From Baseline in FEV1 at Week 12 | 0.20 liters | Standard Error 0.017 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.118595% CI: [-0.009, 0.081]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.265195% CI: [-0.02, 0.072]Mixed Models Analysis
Secondary
Change From Baseline in FEV1 at Week 24
Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 24
Time frame: baseline, 24 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Change From Baseline in FEV1 at Week 24 | 0.20 liters | Standard Error 0.016 |
| Combivent Inhalation Aerosol | Change From Baseline in FEV1 at Week 24 | 0.21 liters | Standard Error 0.016 |
| Atrovent + Albuterol Aerosols | Change From Baseline in FEV1 at Week 24 | 0.21 liters | Standard Error 0.017 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.585295% CI: [-0.058, 0.033]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.724295% CI: [-0.054, 0.038]Mixed Models Analysis
Secondary
Change From Baseline in FEV1 at Week 48
Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 48
Time frame: baseline, 48 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Change From Baseline in FEV1 at Week 48 | 0.22 liters | Standard Error 0.019 |
| Combivent Inhalation Aerosol | Change From Baseline in FEV1 at Week 48 | 0.16 liters | Standard Error 0.019 |
| Atrovent + Albuterol Aerosols | Change From Baseline in FEV1 at Week 48 | 0.23 liters | Standard Error 0.02 |
p-value: 0.032895% CI: [0.005, 0.11]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.889695% CI: [-0.058, 0.05]Mixed Models Analysis
Secondary
Change From Baseline in FVC at Day 1
Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose on test day 1.
Time frame: baseline, day 1
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Change From Baseline in FVC at Day 1 | 0.37 liters | Standard Error 0.026 |
| Combivent Inhalation Aerosol | Change From Baseline in FVC at Day 1 | 0.34 liters | Standard Error 0.027 |
| Atrovent + Albuterol Aerosols | Change From Baseline in FVC at Day 1 | 0.36 liters | Standard Error 0.027 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.40295% CI: [-0.042, 0.105]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.65995% CI: [-0.057, 0.09]Mixed Models Analysis
Secondary
Change From Baseline in FVC at Week 12
Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 12
Time frame: baseline, 12 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Change From Baseline in FVC at Week 12 | 0.38 liters | Standard Error 0.027 |
| Combivent Inhalation Aerosol | Change From Baseline in FVC at Week 12 | 0.31 liters | Standard Error 0.027 |
| Atrovent + Albuterol Aerosols | Change From Baseline in FVC at Week 12 | 0.35 liters | Standard Error 0.027 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.089395% CI: [-0.01, 0.139]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.542495% CI: [-0.052, 0.099]Mixed Models Analysis
Secondary
Change From Baseline in FVC at Week 24
Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 24
Time frame: baseline, 24 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Change From Baseline in FVC at Week 24 | 0.33 liters | Standard Error 0.03 |
| Combivent Inhalation Aerosol | Change From Baseline in FVC at Week 24 | 0.35 liters | Standard Error 0.03 |
| Atrovent + Albuterol Aerosols | Change From Baseline in FVC at Week 24 | 0.35 liters | Standard Error 0.031 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.639695% CI: [-0.104, 0.064]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.645595% CI: [-0.106, 0.066]Mixed Models Analysis
Secondary
Change From Baseline in FVC at Week 48
Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 48
Time frame: baseline, 48 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Change From Baseline in FVC at Week 48 | 0.35 liters | Standard Error 0.032 |
| Combivent Inhalation Aerosol | Change From Baseline in FVC at Week 48 | 0.30 liters | Standard Error 0.033 |
| Atrovent + Albuterol Aerosols | Change From Baseline in FVC at Week 48 | 0.37 liters | Standard Error 0.034 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.259695% CI: [-0.038, 0.141]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.665995% CI: [-0.112, 0.071]Mixed Models Analysis
Secondary
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Time frame: 0 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0 | 2.8 units on a scale | Standard Deviation 1.13 |
| Combivent Inhalation Aerosol | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0 | 2.7 units on a scale | Standard Deviation 1.23 |
| Atrovent + Albuterol Aerosols | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0 | 2.8 units on a scale | Standard Deviation 1.13 |
Secondary
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Time frame: 12 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12 | 2.8 unit on a scale | Standard Error 0.08 |
| Combivent Inhalation Aerosol | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12 | 2.9 unit on a scale | Standard Error 0.08 |
| Atrovent + Albuterol Aerosols | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12 | 2.8 unit on a scale | Standard Error 0.08 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.357895% CI: [-0.31, 0.11]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.743395% CI: [-0.18, 0.25]Mixed Models Analysis
Secondary
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Time frame: 24 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24 | 2.7 unit on a scale | Standard Error 0.08 |
| Combivent Inhalation Aerosol | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24 | 2.8 unit on a scale | Standard Error 0.08 |
| Atrovent + Albuterol Aerosols | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24 | 2.8 unit on a scale | Standard Error 0.08 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.52495% CI: [-0.29, 0.15]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.317195% CI: [-0.34, 0.11]Mixed Models Analysis
Secondary
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Time frame: 3 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3 | 2.7 unit on a scale | Standard Error 0.07 |
| Combivent Inhalation Aerosol | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3 | 2.7 unit on a scale | Standard Error 0.07 |
| Atrovent + Albuterol Aerosols | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3 | 2.8 unit on a scale | Standard Error 0.07 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.569595% CI: [-0.24, 0.13]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.309395% CI: [-0.28, 0.09]Mixed Models Analysis
Secondary
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Time frame: 36 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36 | 2.7 unit on a scale | Standard Error 0.09 |
| Combivent Inhalation Aerosol | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36 | 2.8 unit on a scale | Standard Error 0.09 |
| Atrovent + Albuterol Aerosols | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36 | 2.7 unit on a scale | Standard Error 0.09 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.249995% CI: [-0.38, 0.1]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.614495% CI: [-0.31, 0.18]Mixed Models Analysis
Secondary
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Time frame: 48 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48 | 2.8 unit on a scale | Standard Error 0.09 |
| Combivent Inhalation Aerosol | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48 | 2.7 unit on a scale | Standard Error 0.09 |
| Atrovent + Albuterol Aerosols | Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48 | 2.9 unit on a scale | Standard Error 0.09 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.514295% CI: [-0.16, 0.33]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.269195% CI: [-0.39, 0.11]Mixed Models Analysis
Secondary
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 0
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 0
Time frame: 0 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 0 | 2.1 number of puffs | Standard Deviation 2.63 |
| Combivent Inhalation Aerosol | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 0 | 1.5 number of puffs | Standard Deviation 2.23 |
| Atrovent + Albuterol Aerosols | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 0 | 1.9 number of puffs | Standard Deviation 2.7 |
Secondary
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 12
Time frame: 12 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12 | 1.9 number of puffs | Standard Error 0.14 |
| Combivent Inhalation Aerosol | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12 | 1.9 number of puffs | Standard Error 0.14 |
| Atrovent + Albuterol Aerosols | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12 | 1.7 number of puffs | Standard Error 0.14 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.950695% CI: [-0.4, 0.37]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.236295% CI: [-0.15, 0.62]Mixed Models Analysis
Secondary
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 24
Time frame: 24 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24 | 2.1 number of puffs | Standard Error 0.15 |
| Combivent Inhalation Aerosol | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24 | 2.0 number of puffs | Standard Error 0.15 |
| Atrovent + Albuterol Aerosols | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24 | 1.6 number of puffs | Standard Error 0.16 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.564595% CI: [-0.3, 0.54]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.016395% CI: [0.1, 0.95]Mixed Models Analysis
Secondary
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 3
Time frame: 3 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3 | 1.7 number of puffs | Standard Error 0.1 |
| Combivent Inhalation Aerosol | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3 | 1.8 number of puffs | Standard Error 0.11 |
| Atrovent + Albuterol Aerosols | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3 | 1.7 number of puffs | Standard Error 0.11 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.47695% CI: [-0.4, 0.19]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.697695% CI: [-0.35, 0.23]Mixed Models Analysis
Secondary
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 36
Time frame: 36 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36 | 1.9 number of puffs | Standard Error 0.15 |
| Combivent Inhalation Aerosol | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36 | 2.1 number of puffs | Standard Error 0.15 |
| Atrovent + Albuterol Aerosols | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36 | 1.8 number of puffs | Standard Error 0.16 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.433995% CI: [-0.6, 0.26]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.488695% CI: [-0.28, 0.59]Mixed Models Analysis
Secondary
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 48
Time frame: 48 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48 | 2.0 number of puffs | Standard Error 0.16 |
| Combivent Inhalation Aerosol | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48 | 2.1 number of puffs | Standard Error 0.16 |
| Atrovent + Albuterol Aerosols | Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48 | 1.8 number of puffs | Standard Error 0.16 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.763795% CI: [-0.5, 0.37]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.375595% CI: [-0.24, 0.65]Mixed Models Analysis
Secondary
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Time frame: 48 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Combivent Respimat | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | None | 118 participants | 118 |
| Combivent Respimat | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 1 exacerbation | 27 participants | — |
| Combivent Respimat | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 2 exacerbations | 7 participants | — |
| Combivent Respimat | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 3 exacerbations | 3 participants | — |
| Combivent Respimat | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 4 exacerbations | 1 participants | — |
| Combivent Respimat | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 5 or more exacerbations | 1 participants | — |
| Combivent Inhalation Aerosol | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 5 or more exacerbations | 0 participants | — |
| Combivent Inhalation Aerosol | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | None | 113 participants | 113 |
| Combivent Inhalation Aerosol | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 3 exacerbations | 0 participants | — |
| Combivent Inhalation Aerosol | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 4 exacerbations | 0 participants | — |
| Combivent Inhalation Aerosol | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 1 exacerbation | 32 participants | — |
| Combivent Inhalation Aerosol | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 2 exacerbations | 9 participants | — |
| Atrovent + Albuterol Aerosols | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 1 exacerbation | 37 participants | — |
| Atrovent + Albuterol Aerosols | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 2 exacerbations | 5 participants | — |
| Atrovent + Albuterol Aerosols | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 5 or more exacerbations | 0 participants | — |
| Atrovent + Albuterol Aerosols | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 3 exacerbations | 2 participants | — |
| Atrovent + Albuterol Aerosols | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | None | 110 participants | 110 |
| Atrovent + Albuterol Aerosols | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 4 exacerbations | 0 participants | — |
Secondary
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization
Time frame: 48 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Combivent Respimat | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization | None | 147 participants | 147 |
| Combivent Respimat | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization | 1 exacerbation | 9 participants | — |
| Combivent Respimat | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization | 2 exacerbations | 0 participants | — |
| Combivent Respimat | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization | 3 or more exacerbations | 1 participants | — |
| Combivent Inhalation Aerosol | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization | 3 or more exacerbations | 0 participants | — |
| Combivent Inhalation Aerosol | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization | None | 148 participants | 148 |
| Combivent Inhalation Aerosol | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization | 2 exacerbations | 0 participants | — |
| Combivent Inhalation Aerosol | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization | 1 exacerbation | 6 participants | — |
| Atrovent + Albuterol Aerosols | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization | 3 or more exacerbations | 0 participants | — |
| Atrovent + Albuterol Aerosols | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization | 1 exacerbation | 8 participants | — |
| Atrovent + Albuterol Aerosols | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization | 2 exacerbations | 0 participants | — |
| Atrovent + Albuterol Aerosols | Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization | None | 146 participants | 146 |
Secondary
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0
Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Time frame: 0 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0 | 5.8 units on a scale | Standard Deviation 1.21 |
| Combivent Inhalation Aerosol | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0 | 5.9 units on a scale | Standard Deviation 1.24 |
| Atrovent + Albuterol Aerosols | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0 | 5.8 units on a scale | Standard Deviation 1.1 |
Secondary
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12
Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Time frame: 12 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 | 6.2 unit on a scale | Standard Error 0.09 |
| Combivent Inhalation Aerosol | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 | 6.0 unit on a scale | Standard Error 0.09 |
| Atrovent + Albuterol Aerosols | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 | 5.8 unit on a scale | Standard Error 0.09 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.282695% CI: [-0.11, 0.38]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.001395% CI: [0.16, 0.66]Mixed Models Analysis
Secondary
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24
Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Time frame: 24 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 | 6.3 unit on a scale | Standard Error 0.08 |
| Combivent Inhalation Aerosol | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 | 6.0 unit on a scale | Standard Error 0.08 |
| Atrovent + Albuterol Aerosols | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 | 5.8 unit on a scale | Standard Error 0.09 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.002395% CI: [0.13, 0.59]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: <0.000195% CI: [0.25, 0.71]Mixed Models Analysis
Secondary
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3
Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Time frame: 3 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 | 6.2 unit on a scale | Standard Error 0.08 |
| Combivent Inhalation Aerosol | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 | 6.1 unit on a scale | Standard Error 0.08 |
| Atrovent + Albuterol Aerosols | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 | 5.9 unit on a scale | Standard Error 0.08 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.116795% CI: [-0.05, 0.42]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.002695% CI: [0.13, 0.59]Mixed Models Analysis
Secondary
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36
Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Time frame: 36 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 | 6.4 unit on a scale | Standard Error 0.08 |
| Combivent Inhalation Aerosol | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 | 6.0 unit on a scale | Standard Error 0.09 |
| Atrovent + Albuterol Aerosols | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 | 5.9 unit on a scale | Standard Error 0.09 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.000695% CI: [0.18, 0.65]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.000495% CI: [0.2, 0.68]Mixed Models Analysis
Secondary
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48
Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Time frame: 48 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 | 6.3 unit on a scale | Standard Error 0.09 |
| Combivent Inhalation Aerosol | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 | 6.1 unit on a scale | Standard Error 0.09 |
| Atrovent + Albuterol Aerosols | Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 | 6.0 unit on a scale | Standard Error 0.09 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.067395% CI: [-0.02, 0.47]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.024595% CI: [0.04, 0.54]Mixed Models Analysis
Secondary
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Time frame: 12 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 | 85.9 unit on a scale | Standard Error 1.14 |
| Combivent Inhalation Aerosol | Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 | 78.0 unit on a scale | Standard Error 1.15 |
| Atrovent + Albuterol Aerosols | Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 | 76.3 unit on a scale | Standard Error 1.16 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: <0.000195% CI: [4.71, 11.09]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: <0.000195% CI: [6.44, 12.83]Mixed Models Analysis
Secondary
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Time frame: 24 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 | 86.6 unit on a scale | Standard Error 1.15 |
| Combivent Inhalation Aerosol | Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 | 77.5 unit on a scale | Standard Error 1.16 |
| Atrovent + Albuterol Aerosols | Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 | 78.9 unit on a scale | Standard Error 1.19 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: <0.000195% CI: [5.94, 12.37]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: <0.000195% CI: [4.44, 10.96]Mixed Models Analysis
Secondary
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Time frame: 3 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 | 84.7 unit on a scale | Standard Error 1.07 |
| Combivent Inhalation Aerosol | Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 | 79.4 unit on a scale | Standard Error 1.09 |
| Atrovent + Albuterol Aerosols | Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 | 77.3 unit on a scale | Standard Error 1.08 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.000695% CI: [2.29, 8.28]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: <0.000195% CI: [4.41, 10.39]Mixed Models Analysis
Secondary
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Time frame: 36 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 | 88.2 unit on a scale | Standard Error 1.22 |
| Combivent Inhalation Aerosol | Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 | 76.9 unit on a scale | Standard Error 1.24 |
| Atrovent + Albuterol Aerosols | Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 | 80.5 unit on a scale | Standard Error 1.29 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: <0.000195% CI: [7.9, 14.76]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: <0.000195% CI: [4.23, 11.23]Mixed Models Analysis
Secondary
Physician's Global Evaluation at Week 0
Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8).
Time frame: 0 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Physician's Global Evaluation at Week 0 | 5.1 units on a scale | Standard Deviation 1.18 |
| Combivent Inhalation Aerosol | Physician's Global Evaluation at Week 0 | 4.9 units on a scale | Standard Deviation 1.22 |
| Atrovent + Albuterol Aerosols | Physician's Global Evaluation at Week 0 | 4.9 units on a scale | Standard Deviation 1.26 |
Secondary
Physician's Global Evaluation at Week 12
Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8).
Time frame: 12 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Physician's Global Evaluation at Week 12 | 5.1 unit on a scale | Standard Error 0.08 |
| Combivent Inhalation Aerosol | Physician's Global Evaluation at Week 12 | 5.2 unit on a scale | Standard Error 0.08 |
| Atrovent + Albuterol Aerosols | Physician's Global Evaluation at Week 12 | 5.0 unit on a scale | Standard Error 0.08 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.188495% CI: [-0.36, 0.07]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.697895% CI: [-0.17, 0.26]Mixed Models Analysis
Secondary
Physician's Global Evaluation at Week 24
Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8).
Time frame: 24 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Physician's Global Evaluation at Week 24 | 5.1 unit on a scale | Standard Error 0.08 |
| Combivent Inhalation Aerosol | Physician's Global Evaluation at Week 24 | 5.2 unit on a scale | Standard Error 0.08 |
| Atrovent + Albuterol Aerosols | Physician's Global Evaluation at Week 24 | 5.2 unit on a scale | Standard Error 0.08 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.419795% CI: [-0.32, 0.13]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.394995% CI: [-0.33, 0.13]Mixed Models Analysis
Secondary
Physician's Global Evaluation at Week 3
Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8).
Time frame: 3 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Physician's Global Evaluation at Week 3 | 5.0 unit on a scale | Standard Error 0.07 |
| Combivent Inhalation Aerosol | Physician's Global Evaluation at Week 3 | 5.1 unit on a scale | Standard Error 0.07 |
| Atrovent + Albuterol Aerosols | Physician's Global Evaluation at Week 3 | 5.1 unit on a scale | Standard Error 0.07 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.623695% CI: [-0.23, 0.14]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.334295% CI: [-0.28, 0.09]Mixed Models Analysis
Secondary
Physician's Global Evaluation at Week 36
Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8).
Time frame: 36 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Physician's Global Evaluation at Week 36 | 5.1 unit on a scale | Standard Error 0.09 |
| Combivent Inhalation Aerosol | Physician's Global Evaluation at Week 36 | 5.2 unit on a scale | Standard Error 0.09 |
| Atrovent + Albuterol Aerosols | Physician's Global Evaluation at Week 36 | 5.2 unit on a scale | Standard Error 0.09 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.29995% CI: [-0.38, 0.12]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.140495% CI: [-0.44, 0.06]Mixed Models Analysis
Secondary
Physician's Global Evaluation at Week 48
Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8).
Time frame: 48 weeks
Population: Treated Set is defined as all patients who were randomized and received study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combivent Respimat | Physician's Global Evaluation at Week 48 | 5.2 unit on a scale | Standard Error 0.09 |
| Combivent Inhalation Aerosol | Physician's Global Evaluation at Week 48 | 5.3 unit on a scale | Standard Error 0.09 |
| Atrovent + Albuterol Aerosols | Physician's Global Evaluation at Week 48 | 5.1 unit on a scale | Standard Error 0.1 |
Comparison: Comparison of Combivent Respimat versus Combivent Inhalation Aerosolp-value: 0.46395% CI: [-0.36, 0.16]Mixed Models Analysis
Comparison: Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosolsp-value: 0.382495% CI: [-0.15, 0.38]Mixed Models Analysis