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).

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Sep 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

    • 30 Aug 2017 Status changed from active, no longer recruiting to completed.
    • 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).
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