Table 1.
Clinical studies conducted as part of the FF global clinical development programme in asthma
| Study | Phase | Number of patients | Treatment arms | Study duration, weeks | Primary end-point | Additional end-points | Included in integrated safety analysis |
|---|---|---|---|---|---|---|---|
| Medley et al. [13]a (NCT01499446) | II dose regimen | 575 | FF 100 μg OD morning; FF 100 μg OD evening; FF 250 μg evening; placebo |
4 | Mean change from baseline in daily trough PEF | FEV1, symptom-free days, rescue-free days, withdrawals, safety (AEs, 24-h UFC) | No |
| Woodcock et al. [14]b (NCT00398645) | II dose regimen | 545 | FF 200, 400 μg OD morning; FF 200, 400 μg OD evening; FF 200 μg BD; placebo |
8 | Mean change from baseline in trough FEV1 | Safety (AEs, withdrawals, 24-h UFC) | No |
| Woodcock et al. [15]c (NCT00766090) | II dose regimen | 190 | FF, FP 200 μg OD evening; FF, FP 100 μg BD; placebo |
4 | Mean change from baseline in trough FEV1 | Safety (AEs, 24-h UFC) | No |
| Busse et al. [16]c (NCT00603746) | II dose ranging | 627 | FF 200, 400, 600, 800 μg OD evening; FP 500 μg BD; placebo |
8 | Mean change from baseline in trough FEV1 | Asthma symptom scores, PEF, symptom-free days, rescue-free days, withdrawals, safety (AEs, 24-h UFC) | Yes |
| Bleecker et al. [17]c (NCT00603278) | II dose ranging | 622 | FF 100, 200, 300, 400 μg OD evening; FP 250 μg BD; placebo | 8 | Mean change from baseline in trough FEV1 | PEF, symptom-free and rescue-free periods, withdrawals, safety (AEs, 24-h UFC) | Yes |
| Bateman et al. [18]c (NCT00603382) | II dose ranging | 598 | FF 25, 50, 100, 200 μg OD evening; FP 100 μg BD; placebo |
8 | Mean change from baseline in trough FEV1 | PEF, symptom-free and rescue-free periods, withdrawals, safety (AEs, 24-h UFC) | Yes |
| O’Byrne et al. [19]c (NCT01436071) | III efficacy | 248 | FF 50 μg OD evening; placebo |
12 | Mean change from baseline in trough FEV1 | Rescue-free and symptom-free 24-h periods, PEF, ACT, QoL, safety (AEs, severe exacerbations) | Yes |
| Busse et al. [20]c (NCT01436110) | III efficacy | 351 | FF 50 μg OD evening; FP 100 μg BD; placebo |
24 | Mean change from baseline in trough evening FEV1 | Rescue-free and symptom-free 24-h periods, PEF, ACT, QoL, safety (AEs, severe exacerbations) | Yes |
| Lötvall et al. [21]c (NCT01159912) | III efficacy | 343 | FF 100 μg OD evening; FP 250 μg BD; placebo |
24 | Mean change from baseline in trough evening FEV1 | Rescue-free and symptom-free 24-h periods, PEF, ACT, QoL, safety (AEs, severe exacerbations, 24-h UFC) | Yes |
| Woodcock et al. [22]c (NCT01431950) | III efficacy | 238 | FF 100 μg, 200 μg OD evening | 24 | Mean change from baseline in trough FEV1 | Rescue-free and symptom-free 24-h periods, PEF, ACT, safety (AEs, severe exacerbations, 24-h UFC) | Yes |
| Bleecker et al. [23]c (NCT01165138) | III efficacy | 609 | FF/VI 100/25 μg; FF 100 μg OD evening; placebo |
12 | Mean change from baseline in trough FEV1 and serial (0–24 h) weighted mean FEV1 | Rescue-free and symptom-free 24-h periods, QoL, withdrawals, safety (AEs, severe exacerbations, 24-h UFC) | Yes |
| Bateman et al. [24]c (NCT01086384) | III efficacy | 2019 | FF/VI 100/25 μg, FF 100 μg OD evening | ≥24–78 | Time to first severe exacerbation | Rate of severe exacerbations per patient per year, trough FEV1, safety (hospitalisations, AEs) | Yes |
| O’Byrne et al. [25]c (NCT01134042) | III efficacy | 586 | FF/VI 200/25 μg OD evening; FF 200 μg OD evening; FP 500 μg BD |
24 | Mean change from baseline in trough FEV1 and serial (0–24 h) weighted mean FEV1 | Rescue-free 24-h and symptom-free 24-h periods, QoL, PEF, ACT, safety (AEs, 24-h UFC) | Yes |
| Muraki et al. [26]c (NCT01244984) | III safety | 243 | FF/VI 100/25 μg, FF/VI 200/25 μg, FF 100 μg OD evening | 52 | Safety (AEs, severe exacerbations, 24-h UFC) | PEF, asthma symptom scores | No |
Clinicaltrials.gov study registration numbers are provided in brackets after each study citation
FF/VI 100/25 μg = 92/22 μg (emitted). FF/VI 200/25 μg = 184/22 μg (emitted). FF 100 μg = 90 μg (emitted). FF 200 μg = 182 μg (emitted)
ACT asthma control testTM, AE adverse event, BD twice daily, FEV 1 forced expiratory volume in one second, FF fluticasone furoate, FP fluticasone propionate, OD once daily, PEF peak expiratory flow, QoL quality of life, UFC urinary free cortisol excretion, VI vilanterol
aFF administered via Rotadisk DiskhalerTM
bFF administered via DiskusTM/AccuhalerTM
cFF administered via ELLIPTA® inhaler