Table 2. Phase III studies with tiotropium in adults.
| Patients | Treatment duration (wk) | Baseline therapy | No. (treatment group) | Study drugs | Primary and key secondary endpoints | Difference from placebo | |
|---|---|---|---|---|---|---|---|
| Trial 1 | Trial 2 | ||||||
| Poorly controlled47 | 48 | At least ICS/LABA | 456 | Tiotropium Respimat 5 µg |
Peak FEV1 (Week 24) | 86 (20–152) mL (P=0.010) | 154 (91–217) mL (P<0.001) |
| Trough FEV1 (Week 24) | 88 (27–149) mL (P=0.010) | 111 (53–169) mL (P<0.001) | |||||
| Time to first severe exacerbation | 21% reduction in risk (HR=0.79; 95% CI=0.62–1.00; P=0.030) | ||||||
| ACQ-7 (adjusted mean score) | NS | −0.2 (P=0.003) | |||||
| Symptomatic63 | 52 | At least ICS±LABA | 114 | Tiotropium Respimat 5 µg* |
Trough FEV1 (Week 52) | 112 mL (95% CI=18-207; P=0.020) | |
| Trough FVC (Week 52) | NS | ||||||
| ACQ-7 responder rate (Week 52) | 76.3% tiotropium vs 73.2% placebo | ||||||
| Moderate symptomatic46 | 24 | At least ICS | 519 tiotropium 5 µg |
Tiotropium Respimat 5 µg* |
Peak FEV1 | 198 (142–253) mL (P<0.0001) | 169 (116–222) mL (P<0.0001) |
| Peak FVC | 102 (42–162) mL (P<0.0008) | 89 (30–147) mL (P=0.0031) | |||||
| ACQ-7 (adjusted mean score) | −0.12 (SD=0.04; P=0.0084) | ||||||
| Symptomatic45 | 12 | Low-dose ICS | 155 | Tiotropium Respimat 5 µg* |
Peak FEV1 (Week 12) | 128 mL (95% CI=57-199; P<0.001) | |
| Trough FEV1 (Week 12) | 122 mL (95% CI=49-194; P<0.001) | ||||||
| ACQ-7 total score (Week 12) | 0.014 (95% CI=−118–0.146; P=0.830) | ||||||
ACQ-7, Asthma Control Questionnaire-7; CI, confidence intervals; FEV1, forced expiratory volume in one second; FVC, forced vital capacity; HR, hazard ratio; ICS, inhaled corticosteroids; LABA, long-acting β2-agonist; NS, not significant; SD, standard deviation; wk, week.
*2.5 µg tiotropium Respimat also included in study but not reported here.