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Table 1 Clinical studies conducted as part of the FF global clinical development programme in asthma

From: Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of 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
  1. Clinicaltrials.gov study registration numbers are provided in brackets after each study citation
  2. 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)
  3. 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
  4. aFF administered via Rotadisk DiskhalerTM
  5. bFF administered via DiskusTM/AccuhalerTM
  6. cFF administered via ELLIPTA® inhaler