![]() *Administered as 2 inhalations twice daily. Mean improvement in 1-hour postdose FEV 1 (mL/%) over 12 months (serial spirometry subset): The prespecified primary comparisons for predose FEV 1 were vs placebo and formoterol and the primary comparison for 1-hour postdose was vs placebo. ![]() This study was designed to assess change from baseline to the average over the randomized treatment period in predose FEV 1 and in 1-hour postdose FEV 1. The study included a 2-week run-in period followed by a 12-month treatment period. Subjects were current or ex-smokers with a smoking history of ≥10 pack-years, aged ≥40 years with a clinical diagnosis of COPD and symptoms for >2 years. Study 2 (SUN): A 12-month, randomized, double-blind, double-dummy, placebo-controlled, parallel-group, multicenter study of 1964 patients with COPD compared SYMBICORT pMDI 160/4.5 mcg (n=494), SYMBICORT pMDI 80/4.5 mcg (n=494), formoterol 4.5 mcg (n=495), and placebo (n=481), each administered as 2 inhalations twice daily.
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