Lung function 1

STUDY DESCRIPTIONS

12-week study: Patients who were symptomatic on a mid- to high-dose ICS1

Design: 12-week, randomized, double-blind study that evaluated the safety and efficacy of BREO 100/25, BREO 200/25, and fluticasone furoate (FF) 100 mcg (each administered once daily in the evening). Patients who reported symptoms and/or rescue beta2-agonist use during a 4-week run-in period on mid- to high-dose ICS (≥250 mcg fluticasone propionate [FP] twice daily or equivalent) were randomized to treatment.

Patients: 1039 patients with asthma aged 12 years and older* (mean age: 46 years). At baseline, patients had a mean percent predicted FEV1 of 62%.

*BREO is approved for use in patients ≥18 years of age.

Primary endpoint: wm FEV1 (0-24 hours) at week 12.

Secondary endpoint: trough FEV1 at week 12.

Placebo-controlled 12-week study: Patients who were symptomatic on a low- to mid-dose ICS2

Design: 12-week, randomized, double-blind, placebo-controlled study of 609 patients aged 12 years and older* (mean age: 40 years) with asthma, symptomatic on low- to mid-dose ICS (FP 100 mcg to 250 mcg twice daily or equivalent) during a 4-week run-in period (mean baseline percent predicted FEV1 of 70%) randomized to BREO 100/25, FF 100 mcg, or placebo (each administered once daily in the evening).

*BREO is approved for use in patients ≥18 years of age.

Co-primary endpoints: wm FEV1 (0-24 hours) (in a subset of patients) and trough FEV1 at week 12.