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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.

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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.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

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

    • 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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