A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Stratified, Multi-Center, 12-Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm 100/10 microg or 250/10 microg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI) With the Administration of Placebo or Fluticasone (250 microg Twice Daily) and Formoterol (10 microg Twice Daily) Alone in Adolescent and Adult Patients With Moderate to Severe Asthma

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Stratified, Multi-Center, 12-Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm 100/10 microg or 250/10 microg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI) With the Administration of Placebo or Fluticasone (250 microg Twice Daily) and Formoterol (10 microg Twice Daily) Alone in Adolescent and Adult Patients With Moderate to Severe Asthma

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Dec 2012

At a glance

  • Drugs Formoterol/fluticasone propionate (Primary) ; Fluticasone propionate; Formoterol
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Sponsors SkyePharma AG
  • Most Recent Events

    • 22 Jun 2011 Additional trial location (Puerto Rico) added as reported by ClinicalTrials.gov.
    • 13 Sep 2009 Results presented at the 19th Annual Congress of the European Respiratory Society (ERS).
    • 19 May 2009 Results reported at the 105th International Conference of the American Thoracic Society.
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