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: 13 Sep 2017

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

    • 13 Sep 2017 Results assessing days with COPD exacerbation using e-diary (n=3354) and EXACT-PRO (n=453) presented at the 27th Annual Congress of the European Respiratory Society
    • 13 Sep 2017 Results assessing the rate of moderate/severe exacerbation, and time to first and subsequent exacerbations, presented at the 27th Annual Congress of the European Respiratory Society
    • 24 May 2017 Results of improvement in terms of St. Georges Respiratory Questionnaire component scores presented at the 113th International Conference of the American Thoracic Society
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