Fluticasone propionate/formoterol for COPD management: A randomized controlled trial

This randomized, double-blind study evaluated the efficacy and safety of fluticasone propionate/formoterol fumarate versus formoterol in 1,765 patients with COPD with an FEV1 ≤50% predicted and ≥1 moderate/severe exacerbation in the preceding 12 months. The primary endpoint was the annualized rate of moderate-to-severe COPD exacerbations; secondary endpoints included mean pre- and 1-hour post-dose FEV1 and FVC, annualized rate of EXACT exacerbations, time to first moderate/severe COPD exacerbation, change in SGRQ score, proportion of SGRQ responders, daily rescue medication usage, percentage change in awakening-free nights, and mean E-RS breathlessness and total scores. During a 2-week run-in period, patients used the Vitalograph In2itive e-Diary on a daily basis to record their score for the EXACT-PRO.