Table 3.
Summary of study methods and outcomes of non-comparative trials of Respimat® Soft Mist™ Inhaler (SMI) that assessed patient satisfaction
| Devices compared | Disease | Trial duration | Number of patients | Type of study and drug delivered | Assessment tool | Outcome | Reference or company study code |
|---|---|---|---|---|---|---|---|
| Respimat® SMI alone | COPD | 12 weeks | 47 | Post-clinical trial questionnaire; either ipratropium + fenoterol or placebo | 10-point Likert rating scale: 1 (extremely dissatisfied) to 10 (extremely satisfied) | Ratings of 9 or 10 given by 64% of patients | Boehringer Ingelheim (215.1349) |
| Respimat® SMI alone | COPD | 26 weeks | 129 | Post-clinical trial questionnaire; either ipratropium or placebo | 10-point Likert rating scale: 1 (extremely dissatisfied) to 10 (extremely satisfied) | Ratings of 9 or 10 given by 74% of patients | Boehringer Ingelheim (244.2484) |
| Respimat® SMI alone | COPD and asthma | 4 weeks | 4602 | Observational study, open-label; ipratropium + fenoterol | 5-point rating scale: unsatisfactory to very good | Good or very good ratings from 88.7% of patients for handling, 93% for ease of use | Ref 46 Boehringer Ingelheim (215.1362) |
| Respimat® SMI alone | COPD and asthma | 12 weeks | 2006 | Observational study, open-label; ipratropium + fenoterol | 5-point rating scale: very unsatisfied to very satisfied | 86.3% patients “satisfied” or “very satisfied” with respimat® SMI | Ref 47 Boehringer Ingelheim (215.1363) |