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NCT01450774 Clinical Trial

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

Childhood Asthma 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 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01450774
Other study ID # CCD-1012-PR-0051
Secondary ID
Status Completed
Phase Phase 3
First received September 23, 2011
Last updated March 28, 2017
Start date September 2011
Est. completion date February 2014

Study information
Verified date March 2017
Source Chiesi Farmaceutici S.p.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date February 2014
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group 5 Years to 11 Years
Eligibility Inclusion Criteria:

- Prepuberal male and female outpatients, = 5 and = 11 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

Related Conditions & MeSH terms

Intervention

Drug:
• CHF 1535 50/6µg
fixed combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
• beclomethasone dipropionate 50µg + formoterol fumarate 6µg
free combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg

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 a 2 week treatment
Secondary 24-hour urinary free cortisol/creatinine levels after a 2 week treatment period
Secondary Changes in pre-dose morning and evening PEF (L/min) pre and after a 2 week treatment period
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