Efficacy and safety of two doses of budesonide/formoterol fumarate metered dose inhaler in COPD.

However, treatment differences did not reach statistical significance in this smaller patient sample (HR 0.783 [95% CI 0.590–1.039; p=0.0904] and 0.799 [95% CI 0.603–1.059; p=0.1178], respectively).

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BFF MDI 320/10 μg and 160/10 μg reduced the rate of moderate/severe COPD exacerbations versus FF MDI (rate ratios 0.67 [95% CI 0.54–0.82; p=0.0001] and 0.71 [95% CI 0.58–0.87; p=0.0010], respectively; these endpoints were not included in the Type I error control strategy, so were nominally significant) ( table 2 ).

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