Strong data from 2nd Ph III Flutiform trial

UK drug-delivery specialist SkyePharma says that a second Phase III efficacy study evaluating Flutiform for moderate-to-severe asthma in adolescent and adult patients has met its primary endpoints.

The 557-patient, randomized, double-blind, placebo-controlled, parallel-group, stratified, multicenter trial compared the safety and efficacy of Flutiform (fluticasone and formoterol) versus the administration of either placebo or fluticasone (250g twice daily) or formoterol (10g twice daily) alone. Patients were treated for 12 weeks after initial screening and a 14 day run-in period. In a top-line analysis of key results, the levels of improvement in forced expiratory volume in the first second, the primary endpoint in the active treatment arms, showed statistically-significant differences in favor of Flutiform. In addition, there was a significantly lower number of discontinuations due to lack of efficacy for Flutiform as compared with placebo.