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
1 other identifier
interventional
N/A
1 country
1
Brief Summary
single center, double-blind, double-dummy, 2-way cross over study in asthmatic children already treated with inhaled corticosteroids
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2012
CompletedFirst Posted
Study publicly available on registry
August 7, 2012
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedJune 18, 2018
June 1, 2018
1.7 years
August 3, 2012
June 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Lower Leg Growth rate measured by Knemometry
after 2 weeks of treatment
Secondary Outcomes (2)
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
Study Arms (2)
CHF 1535 50/6 µg
EXPERIMENTALbeclomethasone dipropionate 100µg + Formoterol fumarate 6µg
ACTIVE COMPARATORInterventions
beclomethasone dipropionate 50µg + formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks
beclomethasone dipropionate 100µg, 1 inhalation b.i.d. for 2 weeks and formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- Endocrinological diseases including growth impairment or other chronic diseases;
- Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BørneAstmaKlinikken
Copenhagen, 2100, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2012
First Posted
August 7, 2012
Study Start
February 1, 2014
Primary Completion
November 1, 2015
Study Completion
February 1, 2016
Last Updated
June 18, 2018
Record last verified: 2018-06