Purpose: To evaluate fluticasone propionate/formoterol (FP/FORM) in COPD. Patients and methods: COPD patients with forced expiratory volume in 1 s (FEV1) â¤50% predicted and â¥1 moderate/severe COPD exacerbation in the last 12 months were randomized to FP/FORM 500/20 or 250/10 Î¼g bid, or formoterol (FORM) 12 Î¼g bid for 52 weeks. The primary outcome was the annualized rate of moderate/severe COPD exacerbations. Results: In total, 1,765 patients were randomized. There were fewer discontinuations with FP/FORM 500/20 Î¼g (20.6%) and 250/10 Î¼g (24.0%) compared with FORM (26.1%). None of the two FP/FORM doses reduced the moderate/severe exacerbation rate versus FORM (rate ratios [RR]: 0.93; Pâ¤0.402). There was a trend toward a lower moderate/severe exacerbation rate with FP/FORM 500/20 Î¼g versus FORM in patients with â¥2 exacerbations in the preceding year (RR: 0.79; P=0.084). Pre-and post-dose FEV1 and forced vital capacity were greater with FP/FORM 500/20 Î¼g versus FORM (Pâ¤0.039). There was a trend toward a lower EXAcerbations of Chronic pulmonary disease Tool (EXACT) exacerbation rate with FP/FORM 500/20 Î¼g versus FORM (RR: 0.87; P=0.077). There were more St Georgeâs Respiratory Questionnaire for COPD (SGRQ-C) responders with FP/FORM 500/20 Î¼g than FORM (odds ratios [OR] at weeks 6, 23 and 52 â¥1.28; Pâ¤0.054). EXACT-respiratory symptoms total and breathlessness scores were lower with both FP/FORM 500/20 Î¼g and 250/10 Î¼g versus FORM (Pâ¤0.066). Acute Î²2-agonist-induced effects and 24-hour Holter findings were similar for all treatments. Mean 24-hour urinary cortisol was similarly reduced with both FP/FORM doses. Radiologically confirmed pneumonia was seen in 2.4%, 3.2% and 1.5% of FP/FORM 500/20 Î¼g, FP/FORM 250/10 Î¼g and FORM-treated patients, respectively. Adverse events were otherwise similar across treatment groups. Conclusion: FP/FORM did not reduce exacerbation rates versus FORM. Numerical benefits were observed with FP/FORM 500/20 Î¼g versus FORM for secondary variables, including lung function, EXACT exacerbations, SGRQ-C and EXACT-respiratory symptoms total and breathlessness scores. Few efficacy differences were evident between FP/FORM 250/10 Î¼g and FORM. Pneumonia was more frequent in FP/FORM-treated patients, although the absolute difference was low. Adverse events were otherwise similar between treatments.
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