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 NEXThaler® (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

NCT01658891 Phase 3 WITHDRAWN

single center, double-blind, double-dummy, 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Status	WITHDRAWN
Start date	2014-02
Completion	2016-02

Conditions

• Asthma in Children

Interventions

• combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
• free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg

Primary outcomes

• Lower Leg Growth rate measured by Knemometry — after 2 weeks of treatment

Countries

Denmark