A randomised, double-blind, double-dummy, placebo and active-controlled, three-way crossover study to evaluate the safety, tolerability and efficacy of 28-day inhaled CHF 6001 DPI (1200microgrammes daily) in subjects with COPD

Trial Profile

A randomised, double-blind, double-dummy, placebo and active-controlled, three-way crossover study to evaluate the safety, tolerability and efficacy of 28-day inhaled CHF 6001 DPI (1200microgrammes daily) in subjects with COPD

Completed
Phase of Trial: Phase II

Latest Information Update: 03 Apr 2017

At a glance

  • Drugs CHF 6001 (Primary) ; Roflumilast
  • Indications Chronic obstructive pulmonary disease
  • Focus Adverse reactions; Biomarker; Pharmacodynamics; Pharmacokinetics
  • Sponsors Chiesi Farmaceutici SpA
  • Most Recent Events

    • 26 Mar 2014 Status changed from recruiting to completed as reported by European Clinical Trials Database record.
    • 21 Nov 2012 New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health; NCT01730404).
    • 20 Oct 2012 Planned End Date 1 Aug 2013 added as reported by EudraCT.
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