Mylan will conduct a phase 3 clinical trial to evaluate the equivalence of its generic version of Advair Diskus as inhalation treatment in adults with asthma, according to a press release.
The randomized, double blind, double-dummy, parallel group study will commence in October to determine the local equivalence of Mylan’s generic product to fluticasone propionate and salmeterol inhalation powder (Advair Diskus, GlaxoSmithKline) in adults with asthma, the release said. The study’s primary endpoint is the FEV1 area under the effect curve.
Adverse events and device usability also will be examined. The study is expected to be completed by April.
