Back to resultsComparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children
Primary Purpose
Asthma in Children
Status
Withdrawn
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg
Sponsored by
About this trial
This is an interventional treatment trial for Asthma in Children
Eligibility Criteria
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;
Sites / Locations
- BørneAstmaKlinikken
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CHF 1535 50/6 µg
beclomethasone dipropionate 100µg + Formoterol fumarate 6µg
Arm Description
Outcomes
Primary Outcome Measures
Lower Leg Growth rate measured by Knemometry
Secondary Outcome Measures
24-hour urinary free cortisol/creatinine levels
Changes in pre-dose morning and evening PEF (L/min)
Full Information
NCT ID
NCT01658891
First Posted
August 3, 2012
Last Updated
June 15, 2018
Sponsor
Chiesi Farmaceutici S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT01658891
Brief Title
Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Study Start Date
February 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
single center, double-blind, double-dummy, 2-way cross over study in asthmatic children already treated with inhaled corticosteroids
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CHF 1535 50/6 µg
Arm Type
Experimental
Arm Title
beclomethasone dipropionate 100µg + Formoterol fumarate 6µg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
Intervention Description
beclomethasone dipropionate 50µg + formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks
Intervention Type
Drug
Intervention Name(s)
free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg
Intervention Description
beclomethasone dipropionate 100µg, 1 inhalation b.i.d. for 2 weeks and formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks
Primary Outcome Measure Information:
Title
Lower Leg Growth rate measured by Knemometry
Time Frame
after 2 weeks of treatment
Secondary Outcome Measure Information:
Title
24-hour urinary free cortisol/creatinine levels
Time Frame
after 2 weeks of treatment
Title
Changes in pre-dose morning and evening PEF (L/min)
Time Frame
after 2 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Facility Information:
Facility Name
BørneAstmaKlinikken
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children
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