17 June, 2008 - SkyePharma PLC (LSE: SKP) announces that its second Phase III efficacy study evaluating Flutiform™ for the treatment of moderate to severe asthma in adolescent and adult patients has met its primary endpoints. This is the second of several clinical efficacy studies being carried out in preparation for regulatory filing.The study (SKY2028-3-004) was conducted in centres across the United States and Europe. The full analysis set includes a total of 557 patients. The study was a randomised, double-blind, placebo-controlled, parallel group, stratified, multi-centre study comparing the safety and efficacy of fluticasone and formoterol combination (Flutiform™ 100/10μg or 250/10μg twice daily) in a single inhaler (SkyePharma HFA pMDI) versus the administration of either placebo or fluticasone (250μg twice daily) or formoterol (10μg twice daily) alone in adolescent and adult patients with moderate to severe asthma. Patients were treated for 12 weeks after initial screening and a 14 day run-in period... SkyePharma's Press Release -
