Table 4.
Summary of study methods and satisfaction outcomes of trials that compared Respimat® Soft Mist™ Inhaler (SMI) with another inhaler device using a validated assessment tool (Patient Satisfaction and Preference Questionnaire; PASAPQ) to assess satisfaction scores
| Devices compared | Disease | Trial duration | Number of patients | Type of study and drug delivered | Satisfaction outcome (mean total PASAPQ scores) | Reference or company study code |
|---|---|---|---|---|---|---|
| Respimat® SMI vs HFA pMDI | COPD and asthma | 7 + 7 weeks | 224 | Crossover study, open-label; ipratropium + fenoterol | Respimat® SMI, 83.7; pMDI, 72.9; mean difference, 10.8 (SD, 20.3); P < 0.001 | Ref 27 Boehringer Ingelheim (215.1357) |
| Respimat® SMI vs DPI (Turbuhaler) | Asthma | 12 weeks | 153 | Post-clinical trial questionnaire, double-dummy design; budesonide or placebo | Respimat® SMI, 85.5 (SD, 13.5) Turbuhaler®, 76.9 (16.3), mean difference, 8.6; P < 0.0001 for difference) | Ref 48 Boehringer Ingelheim (1047.16) |
| Respimat® SMI vs DPI (Diskus) | COPD and asthma | 4 weeks | 150 | Observational study, open-label; ipratropium + fenoterol (Respimat® SMI); corticosteroid + LABA (Diskus®) | Respimat® SMI, 80.2; Diskus®, 75.5; mean difference, 4.7; P = 0.001 | Ref 49 Boehringer Ingelheim (215.1366) |
Abbreviations: CFC, chlorofluorocarbon; DPI, dry powder inhaler; HFA, hydrofluoroalkane; LABA, long-acting beta-agonist; pMDI, pressurized metered dose inhaler; SD, standard deviation.