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 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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01658891

Enrollment

Registered

2012-08-07

Start date

2014-02-28

Completion date

2016-02-29

Last updated

2018-06-18

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

Conditions

Asthma in Children

Brief summary

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

Interventions

DRUGcombination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg

beclomethasone dipropionate 50µg + formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks

DRUGfree 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

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 \< 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;

Design outcomes

Primary

Measure	Time frame
Lower Leg Growth rate measured by Knemometry	after 2 weeks of treatment

Secondary

Measure	Time frame
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

Countries

Denmark

Outcome results

None listed

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