NCT01450774

Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children

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: Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

This is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way cross-over study in asthmatic children already treated with inhaled corticosteroids.

Conditions

• Childhood Asthma

Interventions

Type	Name	Description
DRUG	CHF 1535 50/6µg	fixed combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
DRUG	beclomethasone dipropionate 50µg + formoterol fumarate 6µg	free combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-11-01
• Completion: 2014-02-01
• First posted: 2011-10-12
• Last updated: 2017-03-29

Locations

1 site across 1 country: Denmark