The study was conducted in centers across North America and Europe. The full analysis set included a total of 475 patients. The study was a randomized, double-blind, placebo-controlled, parallel group, stratified, multi-center, 12-week study comparing the safety and efficacy of fluticasone and formoterol combination (Flutiform 100/10 micrograms twice daily) in a single inhaler with the administration of placebo or fluticasone (100 micrograms twice daily) or formoterol (10 micrograms twice daily) alone in adolescent and adult patients with mild to moderate asthma. Patients were treated for 12 weeks after initial screening and a two to four week run-in period.
In a top-line analysis of key results, the levels of improvement in FEV1 (forced expiratory volume in the first second), the primary endpoint in the active treatment arms, showed statistically significant differences in favor of Flutiform compared with both fluticasone and formoterol taken alone. In addition, the results demonstrated a significantly lower number of discontinuations due to lack of efficacy for Flutiform compared with placebo.
Recruitment is on track to be completed in July for the additional efficacy study required for the US new drug application (NDA) and the overall development program remains on schedule for the NDA to be filed in the first quarter of 2009, the company said.