ITT patients (N) | Trial duration (weeks) | Treatment arms | Primary endpoint | |
---|---|---|---|---|
Dransfield et al. HZC102871 (NCT01009463) [18] | 1622 | 52 | FF/VI: 50/25 μg, 100/25 μg, 200/25 μg (QD) VI: 25 μg (QD) | Annual rate of moderate and severe COPD exacerbations |
Dransfield et al. HZC102970 (NCT01017952) [18] | 1633 | 52 | FF/VI: 50/25 μg, 100/25 μg, 200/25 μg (QD) VI: 25 μg (QD) | Annual rate of moderate and severe COPD exacerbations |
Kerwin et al. HZC112206 (NCT01053988) [19] | 1030 | 24 | FF/VI: 50/25 μg, 100/25 μg (QD) FF: 100 μg (QD) VI: 25 μg (QD) | Change from baseline in weighted mean FEV1 over 0–4 h post-dose at Day 168; Change from baseline in clinic visit trough (pre-bronchodilator and predose) FEV1 at Day 169 |
INSPIRE SCO40036 (NCT00361959) [9] | 1323 | 104 | FP/SAL: 500/50 μg (BD) TIO: 18 μg (QD) | Rate of healthcare-utilization-based exacerbations of COPD |
TRISTAN | 1465 | 52 | FP/SAL: 500/50 μg (BD) FP: 500 μg (BD) SAL: 50 μg (BD) | Pre-bronchodilator FEV1 at Week 52 |
Martinez et al. HZC112207 (NCT01054885) [22] | 1224 | 24 | FF/VI: 100/25 μg, 200/25 μg (QD) FF: 100 μg, 200 μg (QD) VI: 25 μg (QD) | Change from baseline in weighted mean FEV1 over 0–4 h post-dose at Day 168; change from baseline in trough FEV1 at Day 169 |
SCO100470 [23] | 1050 | 24 | FP/SAL: 250/50 μg (BD) SAL: 50 μg (BD) | Mean trough FEV1 at endpoint*, mean TDI focal score at endpoint* |
SCO30002 [24] | 387 | 52 | FP/SAL: 500/50 μg (BD) FP: 500 μg (BD) | Time from the start of treatment to the first moderate or severe exacerbation |
Mahler et al. SFCA3006 [25] | 674 | 24 | FP/SAL: 500/50 μg (BD) FP: 500 μg (BD) SAL: 50 μg (BD) | Mean change from baseline in AM pre-dose and 2-h post-dose FEV1 |
Hanania et al. | 723 | 24 | FP/SAL: 250/50 μg (BD) FP: 250/50 μg (BD) SAL: 50 μg (BD) | Mean change from baseline in AM pre-dose and 2-h post-dose FEV1 |