Fluticasone propionate/formoterol for COPD management: a randomized controlled trial.

In patients with at least 2 moderate/severe COPD exacerbations in the year preceding the study, there was a 21% reduction in the rate of moderate/severe events with FP/FORM 500/20 μg versus FORM that marginally failed to achieve significance at the 5% level (rate ratios [RR]: 0.79 [95% CI: 0.61, 1.03]; P =0.084); whereas exacerbation rates were similar for FP/FORM 250/10 μg and monotherapy (RR: 1.09 [95% CI: 0.85, 1.40]; P =0.484).

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In comparison to FORM, there was an apparent trend in favor of the higher FP/FORM dose in terms of risk reduction in frequent exacerbators, lung function, EXACT exacerbations, SGRQ-C responders and time to CID.

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There was a 13% reduction in the annualized rate of EXACT exacerbations with FP/FORM 500/20 μg versus FORM that approached significance at the 5% level, whereas EXACT exacerbation rates were similar for FP/FORM 250/10 μg and FORM ( Table 4 ).

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