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

Asthma in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01658891
• Other study ID #: CCD-1110-PR-0071
• Status: Withdrawn
• Phase: Phase 3
• Start date: February 2014
• Est. completion date: February 2016

Study information

• Verified date: June 2018
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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;

Related Conditions & MeSH terms

• Asthma in Children

Intervention

Drug:
• combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
beclomethasone dipropionate 50µg + formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks
• free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg
beclomethasone dipropionate 100µg, 1 inhalation b.i.d. for 2 weeks and formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks

Locations

Country	Name	City	State
Denmark	BørneAstmaKlinikken	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower Leg Growth rate measured by Knemometry		after 2 weeks of treatment
Secondary	24-hour urinary free cortisol/creatinine levels		after 2 weeks of treatment
Secondary	Changes in pre-dose morning and evening PEF (L/min)		after 2 weeks of treatment