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

Phase 3

Withdrawn

• Conditions: Asthma in Children
• Interventions: Drug: combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg; Drug: free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg

• Registration Number: NCT01658891
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

single center, double-blind, double-dummy, 2-way cross over study in asthmatic children already treated with inhaled corticosteroids

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-03
• Study First Submitted QC: 2012-08-03
• Study First Posted: 2012-08-07
• Study Start: 2014-02
• Primary Completion: 2015-11
• Study Completion: 2016-02
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-15
• Last Update Posted: 2018-06-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Prepuberal male and female outpatients, ≥ 5 and < 12 years old in Tanner stadium I according to Investigator's assessment;
• Clinical diagnosis of mild asthma during at least two months prior to screening visit;
• Forced Expiratory Volume during the first second (FEV1) > 80% of predicted normal values at screening visit;

Exclusion Criteria

• Endocrinological diseases including growth impairment or other chronic diseases;
• Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CHF 1535 50/6 µg	combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg	-
beclomethasone dipropionate 100µg + Formoterol fumarate 6µg	free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg	-

Primary Outcome Measures

Name	Time	Method
Lower Leg Growth rate measured by Knemometry	after 2 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
24-hour urinary free cortisol/creatinine levels	after 2 weeks of treatment
Changes in pre-dose morning and evening PEF (L/min)	after 2 weeks of treatment

Trial Locations

Locations (1)

BørneAstmaKlinikken; 🇩🇰 Copenhagen, Denmark