Symptom Data 1
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.
Secondary endpoints1,4: Percentages of rescue-free and symptom-free 24-hour periods during the 12-week treatment period (baseline percentages during the 4-week run-in period were 4.4% and 3.8% for BREO 100/25, and 4.4% and 4.8% for FF 100 mcg, respectively).