Lung function 4

STUDY DESCRIPTION

24-week study: Patients who were symptomatic on a mid- to high-dose ICS5

Design: 24-week, randomized, double-blind, double-dummy, active control study that evaluated the safety and efficacy of BREO 200/25 and FF 200 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: 586 patients with asthma aged 12 years and older* (mean age: 46 years). At baseline, patients had a mean percent predicted FEV1 of 67%.

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

Co-primary endpoints: wm FEV1 (0-24 hours) (calculated in a subset of patients performing serial FEV1 at the end of 24 weeks) and trough FEV1 at the end of the 24-week treatment period.