- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01450774
Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children
March 28, 2017 updated by: Chiesi Farmaceutici S.p.A.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Copenhagen, Denmark, 2100
- BørneAstmaKlinikken
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CHF 1535 50/6µg
|
fixed combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
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Active Comparator: beclomethasone dipropionate 50µg + formoterol fumarate 6µg
|
free combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lower leg growth rate measured by knemometry
Time Frame: after a 2 week treatment
|
after a 2 week treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
24-hour urinary free cortisol/creatinine levels
Time Frame: after a 2 week treatment period
|
after a 2 week treatment period
|
Changes in pre-dose morning and evening PEF (L/min)
Time Frame: pre and after a 2 week treatment period
|
pre and after a 2 week treatment period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hans Bisgaard, MD, BørneAstmaKlinikken
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
September 23, 2011
First Submitted That Met QC Criteria
October 10, 2011
First Posted (Estimate)
October 12, 2011
Study Record Updates
Last Update Posted (Actual)
March 29, 2017
Last Update Submitted That Met QC Criteria
March 28, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Beclomethasone
- Formoterol Fumarate
Other Study ID Numbers
- CCD-1012-PR-0051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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