A single- dose, open label, randomized, 3-way crossover, clinical pharmacology study of CHF 1535 100/6 pMDI (fixed combination of beclomethazone dipropionate 100 μg plus formoterol fumarate 6 μg) with or without spacer device versus the free combination of licensed beclomethasone pMDI and formoterol pMDI in asthmatic adolescent patients and one open arm for adult patients as control group treated with CHF 1535 100/6 pMDI.

Trial Profile

A single- dose, open label, randomized, 3-way crossover, clinical pharmacology study of CHF 1535 100/6 pMDI (fixed combination of beclomethazone dipropionate 100 μg plus formoterol fumarate 6 μg) with or without spacer device versus the free combination of licensed beclomethasone pMDI and formoterol pMDI in asthmatic adolescent patients and one open arm for adult patients as control group treated with CHF 1535 100/6 pMDI.

Completed
Phase of Trial: Phase II

Latest Information Update: 25 Mar 2015

At a glance

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

    • 11 Sep 2013 Results presented at the 23rd Annual Congress of the European Respiratory Society.
    • 01 Mar 2013 New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health; NCT01803087).
    • 04 Feb 2013 New trial record
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