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: 24 May 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

    • 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
    • 24 May 2017 Results comparing patient characteristics from SLS COPD with SUMMIT, TORCH, FLAME and TRILOGY trials presented at the 113th International Conference of the American Thoracic Society
    • 24 May 2017 Results (n=2514) comparing the effect of indacaterol/glycopyrronium versus salmeterol/fluticasone on the rate and risk of moderate or severe exacerbations in a subset of GOLD Group D patients who had a history of ≥2 exacerbations or 1 hospitalization for exacerbation from the FLAME study, presented at the 113th International Conference of the American Thoracic Society.
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