Table 1.
Phase III trials investigating tiotropium in adults, adolescents, and children with severe asthma.
| Trial(s) | ClinicalTrials.gov number(s) | Background treatment | Age, years | Trial duration, weeks | Week of primary endpoint reporting | Patients, n | Tiotropium 5 μ g versus placebo a , mL | Tiotropium 2.5 μ g versus placebo a , mL |
|---|---|---|---|---|---|---|---|---|
| PrimoTinA-asthma [25] | NCT00772538 NCT00776984 | High-dose ICS + LABA | 18–75 | 48 | 24 | 912 |
Peak FEV
1(0–3h)
response: 86, P<0.05 154, P<0.001 Trough FEV1 response: 88, P<0.01 111, P<0.001 ACQ response: –0.13, P=0.06 –0.20, P=0.003 ACQ responder rate:NR |
N/A |
|
| ||||||||
| PensieTinA-asthma [35] | NCT01277523 | High-dose ICS + ≥1 controllersb or Medium-dose ICS + ≥2 controllersb | 12–17 | 12 | 12 | 392 |
Peak FEV
1(0–3h)
response: 90, P=0.104 Trough FEV1 response: 54, P=0.361 ACQ-7 response: 0.036, P=NR ACQ-7 responder rate: NR, P=0.952 |
Peak FEV
1(0–3h)
response: 111, P=0.046 Trough FEV1 response: 115, P=0.051 ACQ-7 response: 0.058, P=NR ACQ-7 responder rate: NR, P=0.802 |
|
| ||||||||
| VivaTinA-asthma [34] | NCT01634152 | High-dose ICS + ≥1 controllersb or Medium-dose ICS + ≥2 controllersb | 6–11 | 12 | 12 | 400 |
Peak FEV
1(0–3h)
response: 139, P<0.001 Trough FEV1 response: 87, P=0.01 ACQ-IA response: –0.08, P=0.32 ACQ-IA responder rate: 80.8% vs. 76.9%, P=NR |
Peak FEV
1(0–3h)
response: 35, P=0.27 Trough FEV1 response: 18, P=0.59 ACQ-IA response: 0.02, P=0.80 ACQ-IA responder rate: 79.4% vs. 76.9%, P=NR |
aAt week of primary endpoint reporting; be.g., LABA and/or leukotriene receptor antagonist and/or sustained-release theophylline. ACQ-7, seven-question Asthma Control Questionnaire; ACQ-IA, interviewer-administered version of the Asthma Control Questionnaire; FEV1, forced expiratory volume in 1s; FEV1(0–3h), FEV1 within 3 hours after dose; LABA, long-acting β2-agonsit; N/A, not applicable; NR, not reported; NS, not significant.