Randomized, Placebo-controlled Study Comparing Efficacy of Fluticasone/Salmeterol Combination to Advair in Asthmatics

This pivotal trial will examine therapeutic equivalence of a new generic fixed-dose combination product containing fluticasone propionate 100 mcg / salmeterol 50 mcg (as xinafoate salt) and reference listed drug (RLD) Advair® Diskus 100/50 in adult patients with chronic but stable asthma as defined in National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP 3) guidelines \[2\]. To ensure adequate study sensitivity the test and reference products should both be statistically superior to placebo (p\<0.05) with regard to the BE study primary endpoints. A secondary study objective is the safety and tolerability of the test compound.