NCT01019694已完成3 期
Patient Acceptability of Ipratropium Bromide/Albuteroll Delivered by the Respimat® Inhaler in Adults With Chronic Obstructive Pulmonary Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 470
- 试验地点
- 55
- 主要终点
- Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Combivent Respimat 20/100 microgram(mcg)
Experimental
patient to take 1 inhalation 4 times a day
干预措施: Combivent Respimat 20/100 mcg (Drug)
Combivent CFC-MDI 36/206 microgram-mcg
Active Comparator
patient to take 2 inhalations 4 times a day
干预措施: Combivent CFC-MDI (Drug)
Atrovent HFA 42 mcg + Albuterol HFA
Active Comparator
patient to take 2 inhalations of each 4 times a day
干预措施: Atrovent HFA 42 mcg + Albuterol HFA 200 mcg (Drug)
结局指标
主要结局
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48
时间窗: 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).
次要结局
- Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0(0 weeks)
- Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12(12 weeks)
- Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3(3 weeks)
- Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24(24 weeks)
- Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36(36 weeks)
- Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48(48 weeks)
- Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0(0 weeks)
- Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3(3 weeks)
- Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12(12 weeks)
- Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24(24 weeks)
- Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36(36 weeks)
- Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48(48 weeks)
- Physician's Global Evaluation at Week 0(0 weeks)
- Physician's Global Evaluation at Week 3(3 weeks)
- Physician's Global Evaluation at Week 12(12 weeks)
- Physician's Global Evaluation at Week 24(24 weeks)
- Physician's Global Evaluation at Week 36(36 weeks)
- Physician's Global Evaluation at Week 48(48 weeks)
- Change From Baseline in FEV1 at Day 1(baseline, day 1)
- Change From Baseline in FEV1 at Week 12(baseline, 12 weeks)
- Change From Baseline in FEV1 at Week 24(baseline, 24 weeks)
- Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3(3 weeks)
- Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12(12 weeks)
- Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24(24 weeks)
- Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36(36 weeks)
- Change From Baseline in FEV1 at Week 48(baseline, 48 weeks)
- Change From Baseline in FVC at Day 1(baseline, day 1)
- Change From Baseline in FVC at Week 12(baseline, 12 weeks)
- Change From Baseline in FVC at Week 24(baseline, 24 weeks)
- Change From Baseline in FVC at Week 48(baseline, 48 weeks)
- 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 in Two Weeks Prior to Week 3(3 weeks)
- 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 in Two Weeks Prior to Week 24(24 weeks)
- 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 in Two Weeks Prior to Week 48(48 weeks)
- 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)
研究者
研究点 (55)
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