Prospective, randomised, open-label, multicentre, active drug controlled, parallel group design clinical trial of the efficacy and safety of beclomethasone dipropionate 400 mcg + formoterol 24 mcg pMDI [pressurised metered-dose inhaler] via hydrofluoroalkane-134a (Foster) vs. fluticasone propionate 500 mcg + salmeterol xinafoate 100 mcg DPI [dry powder inhaler] (Seretide Diskus) in the 6 months stepdown treatment of adult patients with controlled asthma.

Trial Profile

Prospective, randomised, open-label, multicentre, active drug controlled, parallel group design clinical trial of the efficacy and safety of beclomethasone dipropionate 400 mcg + formoterol 24 mcg pMDI [pressurised metered-dose inhaler] via hydrofluoroalkane-134a (Foster) vs. fluticasone propionate 500 mcg + salmeterol xinafoate 100 mcg DPI [dry powder inhaler] (Seretide Diskus) in the 6 months stepdown treatment of adult patients with controlled asthma.

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Apr 2017

At a glance

  • Drugs Beclometasone/formoterol; Salmeterol/fluticasone propionate
  • Indications Asthma
  • Focus Therapeutic Use
  • Acronyms FORTE
  • Sponsors Chiesi Farmaceutici
  • Most Recent Events

    • 21 Apr 2012 Planned number of patients changed from 382 to 450 as reported by European Clinical Trials Database.
    • 27 Apr 2010 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
    • 27 Apr 2010 Actual end date (1 Mar 2010) added as reported by ClinicalTrials.gov record.
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