Table 1.
Key results of Phase III adult asthma studies with tiotropium Respimat® 5μg
| Study name | Treatment duration, weeks | N | Primary and key secondary endpoints | Difference from placebo | |
|---|---|---|---|---|---|
| PrimoTinA-asthma® Severe persistent asthma37 | 48 | 912 | Peak FEV1, Week 24, mean (CI) mL | 86 (20, 152) (P=0.01) Trial 1 |
Trial 2 154 (91, 217) (P<0.001) |
| Trough FEV1, Week 24, mean (CI) mL | 88 (27, 149) (P=0.01) Trial 1 |
Trial 2 111 (53, 169) (P<0.001) | |||
| Time to first severe exacerbation | –0.2 (P=0.003) Trial 2 21% reduction in risk (HR 0.79; 95% CI: 0.62, 1.00; P=0.03) |
||||
| ACQ-7, adjusted mean score | NS | ||||
| MezzoTinA-asthma® Moderate persistent asthma38 | 24 | 2103 | Peak FEV1, mean (CI) mL | 198 (142, 253) (P<0.0001) Trial 1 |
(P<0.0001) Trial 2 169 (116, 222) |
| Peak FVC, mean (CI) mL | 102 (42, 162) (P=0.0008) Trial 1 |
(P=0.0031) Trial 2 89 (30, 147) |
|||
| ACQ-7, adjusted mean score | –0.12 (SD 0.04; P=0.0084) | ||||
| GraziaTinA-asthma® Mild persistent asthma39 | 12 | 465 | Peak FEV1, Week 12 mean (CI) mL | 128 (57, 199) (P<0.001) | |
| Trough FEV1, Week 12 mean (CI) mL | 122 (49, 194) (P<0.001) | ||||
| ACQ-7 total score, Week 12 | 0.014 (–118, 0.146) (P=0.83) | ||||
| CadenTinA-asthma® Symptomatic asthma40 | 52 | 285 | Long-term safety | Incidence of patients reporting AEs was similar across treatment groups | |
| Trough FEV1, Week 52 mean (CI) mL | 112 (18, 207) (P=0.0203) | ||||
Abbreviations: ACQ-7, 7-question asthma control questionnaire; AE, adverse event; CI, confidence interval; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; HR, hazard ratio; ICS, inhaled corticosteroids; NS, not significant; SD, standard deviation.