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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01450774

Enrollment

Registered

2011-10-12

Start date

2011-09-30

Completion date

2014-02-28

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Asthma

Brief 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.

Interventions

DRUGCHF 1535 50/6µg

fixed combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg

DRUGbeclomethasone dipropionate 50µg + formoterol fumarate 6µg

free combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 11 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Lower leg growth rate measured by knemometry	after a 2 week treatment

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026