A phase II, multinational, multicentre, double blind, double dummy, randomised, 5-way cross-over, placebo and active controlled clinical study to test the non-inferiority of a single dose of CHF 1535 (fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg dry powder) via NEXT DPI 1 or 4 inhalations versus CHF 1535 (beclomethasone dipropionate 100 µg plus formoterol fumarate 6 microg) pMDI with HFA-134a propellant 1 or 4 puffs on FEV1 AUC0-12h in partly controlled adult asthmatic patients

Trial Profile

A phase II, multinational, multicentre, double blind, double dummy, randomised, 5-way cross-over, placebo and active controlled clinical study to test the non-inferiority of a single dose of CHF 1535 (fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg dry powder) via NEXT DPI 1 or 4 inhalations versus CHF 1535 (beclomethasone dipropionate 100 µg plus formoterol fumarate 6 microg) pMDI with HFA-134a propellant 1 or 4 puffs on FEV1 AUC0-12h in partly controlled adult asthmatic patients

Completed
Phase of Trial: Phase II

Latest Information Update: 04 Apr 2017

At a glance

  • Drugs Beclometasone/formoterol (Primary)
  • Indications Asthma
  • Focus Therapeutic Use
  • Most Recent Events

    • 04 Jul 2012 Additional trial locations (France and Italy) added as reported by European Clinical Trials Database record.
    • 22 Dec 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 19 Jun 2009 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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