Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Registration Number
- NCT01019694
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 470
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combivent Respimat 20/100 microgram(mcg) Combivent Respimat 20/100 mcg patient to take 1 inhalation 4 times a day Combivent CFC-MDI 36/206 microgram-mcg Combivent CFC-MDI patient to take 2 inhalations 4 times a day Atrovent HFA 42 mcg + Albuterol HFA Atrovent HFA 42 mcg + Albuterol HFA 200 mcg patient to take 2 inhalations of each 4 times a day
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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).
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).
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).
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).
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
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).
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).
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
Trial Locations
- Locations (55)
1012.62.153 Boehringer Ingelheim Investigational Site
🇺🇸Jasper, Alabama, United States
1012.62.145 Boehringer Ingelheim Investigational Site
🇺🇸Mobile, Alabama, United States
1012.62.156 Boehringer Ingelheim Investigational Site
🇺🇸Mesa, Arizona, United States
1012.62.135 Boehringer Ingelheim Investigational Site
🇺🇸Berkeley, California, United States
1012.62.141 Boehringer Ingelheim Investigational Site
🇺🇸Riverside, California, United States
1012.62.155 Boehringer Ingelheim Investigational Site
🇺🇸Boulder, Colorado, United States
1012.62.126 Boehringer Ingelheim Investigational Site
🇺🇸Fort Collins, Colorado, United States
1012.62.131 Boehringer Ingelheim Investigational Site
🇺🇸Wheat Ridge, Colorado, United States
1012.62.144 Boehringer Ingelheim Investigational Site
🇺🇸Stamford, Connecticut, United States
1012.62.123 Boehringer Ingelheim Investigational Site
🇺🇸Waterbury, Connecticut, United States
Scroll for more (45 remaining)1012.62.153 Boehringer Ingelheim Investigational Site🇺🇸Jasper, Alabama, United States