A randomised, double-blind, double dummy, parallel group study comparing Fluticasone propionate / formoterol fumarate (flutiform) 250/10 mcg (2 puffs BID) and flutiform 125/5 mcg (2 puffs BID) versus Formoterol fumarate dihydrate (Atimos) 12 mcg (1 puff BID) in subjects with chronic obstructive pulmonary disease (COPD).

Trial Profile

A randomised, double-blind, double dummy, parallel group study comparing Fluticasone propionate / formoterol fumarate (flutiform) 250/10 mcg (2 puffs BID) and flutiform 125/5 mcg (2 puffs BID) versus Formoterol fumarate dihydrate (Atimos) 12 mcg (1 puff BID) in subjects with chronic obstructive pulmonary disease (COPD).

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Mar 2017

At a glance

  • Drugs Formoterol/fluticasone propionate (Primary) ; Formoterol
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Mundipharma GmbH
  • Most Recent Events

    • 21 Mar 2017 According to a Vectura media release, data from trial will be presented during 2017.
    • 30 Aug 2016 According to a media release, the company carried out this study to support a filing to expand the approved indication for the regular treatment of asthma of flutiform in Europe to include chronic obstructive pulmonary disease (COPD).
    • 30 Aug 2016 According to a media release, Mundipharma is currently undertaking an analysis of the trial's other endpoints but has indicated that the primary endpoint result will not allow it to make a regulatory filing for the COPD indication in Europe.
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