A SINGLE CENTRE, RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, 2-WAY CROSS OVER STUDY TO COMPARE SAFETY ASSESSED BY KNEMOMETRY AND URINARY CORTISOL MEASUREMENTS OF CHF1535 50/6 pMDI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE AND FORMOTEROL FUMARATE) AND THE FREE COMBINATION OF LICENSED BECLOMETHASONE DIPROPIONATE AND FORMOTEROL FUMARATE IN ASTHMATIC CHILDREN ALREADY TREATED WITH INHALED CORTICOSTEROIDS.

Trial Profile

A SINGLE CENTRE, RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, 2-WAY CROSS OVER STUDY TO COMPARE SAFETY ASSESSED BY KNEMOMETRY AND URINARY CORTISOL MEASUREMENTS OF CHF1535 50/6 pMDI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE AND FORMOTEROL FUMARATE) AND THE FREE COMBINATION OF LICENSED BECLOMETHASONE DIPROPIONATE AND FORMOTEROL FUMARATE IN ASTHMATIC CHILDREN ALREADY TREATED WITH INHALED CORTICOSTEROIDS.

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Apr 2017

At a glance

  • Drugs Beclometasone/formoterol (Primary) ; Beclometasone; Formoterol
  • Indications Asthma
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Chiesi Farmaceutici SpA
  • Most Recent Events

    • 29 Apr 2014 Trial status changed to completed as reported by ClinicalTrials.gov.
    • 01 Aug 2012 Planned End Date changed from 1 Jun 2012 to 1 Apr 2014 as reported by ClinicalTrials.gov.
    • 11 Oct 2011 New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health; NCT01450774).
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