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

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