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A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Fluticasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD

Trial Profile

A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Fluticasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jul 2019

At a glance

  • Drugs Glycopyrrolate/indacaterol (Primary) ; Salmeterol/fluticasone propionate
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms FLAME
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 22 May 2019 Results assessing cost-effectiveness analysis of Indacaterol/Glycopyrronium (Ind/Gly) vs Salmeterol/Fluticasone (Sfc) as Maintenance Treatment for Copd Patients in Taiwan, presented at the 24th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research.
    • 19 Sep 2018 Results assessing Early Clinically Important Improvement (ECII) and exacerbation outcomes in Chronic-obstructive-pulmonary-disease patients, presented at the 28th Annual Congress of the European Respiratory Society.
    • 31 Aug 2018 Biomarkers information updated
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