Exacerbation Data

STUDY DESCRIPTION

24- to 76-week study: Patients with an asthma exacerbation history3

Design: 24- to 76-week, randomized, double-blind, event-driven trial that evaluated the long-term safety and efficacy of BREO 100/25 compared with FF 100 mcg (each administered once daily in the evening). Patients with a history of 1 or more asthma exacerbations in the prior year that required treatment with oral/systemic corticosteroids or ED visit or inpatient hospitalization, and who were being treated with a low- to high-dose ICS or low- to mid-dose ICS/LABA entered a 2-week run-in period during which LABA treatment was stopped. Patients who reported symptoms and/or rescue beta2-agonist use during the 2-week run-in period were randomized to receive treatment, which varied in duration from 24 to 76 weeks, as the study was stopped when 330 events had occurred. An event was defined as a patient experiencing an asthma exacerbation.

Asthma exacerbation criteria: a deterioration of asthma that required the use of systemic corticosteroids for at least 3 days or an inpatient hospitalization or ED visit due to asthma that required systemic corticosteroids.

Patients who experienced 1 or more exacerbations: BREO 100/25, n=154; FF 100 mcg, n=186. The total number of exacerbation events was 200 for BREO and 271 for FF 100 mcg. Management of all exacerbations required use of systemic/oral corticosteroids.

Patients: 2019 patients with asthma aged 12 years and older* (mean age: 42 years). At baseline, patients had a mean percent predicted FEV1 of 72%.

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

Primary endpoint: time to first asthma exacerbation.

Secondary endpoint: rate of asthma exacerbations (per patient per year).