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

NCT01450774 Phase 3 COMPLETED

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.

Details

Lead sponsor	Chiesi Farmaceutici S.p.A.
Phase	Phase 3
Status	COMPLETED
Enrolment	72
Start date	2011-09
Completion	2014-02

Conditions

• Childhood Asthma

Interventions

• CHF 1535 50/6µg
• beclomethasone dipropionate 50µg + formoterol fumarate 6µg

Primary outcomes

• Lower leg growth rate measured by knemometry — after a 2 week treatment

Countries

Denmark