医学交流课件：Post-ATS FLAME MSL deck and QA.pptxVIP

FLAME is part of the Ultibro IGNITE programFLAME Study locationsArgentina – 30Austria – 11Belgium – 22Brazil – 10Bulgaria – 9Canada – 17Chile – 4China – 23Colombia – 4Croatia – 3Czechia – 18Denmark – 9 Egypt – 1Estonia – 3Finland – 6France – 17Germany – 75Greece – 11Guatemala – 3Hong Kong – 3Hungary – 6Iceland – 1India – 23Italy – 19Japan – 30Korea – 11Latvia – 4Lithuania – 12Mexico – 7Netherlands – 10Norway – 10Philippines – 3Poland – 7Portugal – 11Romania – 18Russia – 11Serbia – 4Slovakia – 16South Africa – 11Spain – 32Sweden – 8Taiwan – 8Thailand – 4Turkey – 8UK – 20356 locationsin43 countriesFLAME Study overviewStudy detailInformationPIJorn Ossum GronertPrimary endpointRate of all (mild/mod/severe) COPD exacerbations(non-inferiority over 52 weeks)Secondary endpointsRate of all COPD exacerbations (potential superiority over 52wks) Time to first COPD exacerbationRate of mod/severe exacerbations (requiring antibiotics/systemic steroids/hospitalisation)Lung functionHealth statusSafety tolerabilityObjectiveTo evaluate the effect of Ultibro? vs. salmeterol/fluticasone (SFC) on exacerbations in moderate to very severe COPD patients with a history of exacerbations (GOLD B and D)To show that Ultibro? is non-inferior to SFC for annual rate of all COPD exacerbations (mild/moderate/severe)To evaluate potential superiority of Ultibro? vs. SFC for annual rate of all exacerbationsTo evaluate the rate of (and time to first) moderate/severe COPD exacerbations, lung function, health status, safety and tolerabilityPre-randomization periodDouble-blind treatment period30-day post-safety follow-up2760 Completed 52 weeks4942 Patients entered run-in5328 Patients screened3362 Patients randomizedScreening periodRun-in periodIND/GLY 110/50 μg q.d (Breezhaler)Tiotropium 18μg q.dKey datesStudy initiationJuly 2013Study completionPrimary endpoint Sep 20151Initial results press release17th November 2015Keynote presentation16th May 2016 (ATS)Full results published16th May 2016 (NEJM)2SFC 50/50