Back to resultsShort- and Long Term Growth in Children With Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Budesonide
Montelukast
Sponsored by
About this trial
This is an interventional supportive care trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- age 6-11,
- prepubertal,
- asthma,
- normal weight and height,
- informed consent
Exclusion Criteria:
- treatment with systemic/inhaled/intranasal corticosteroids within the last week,
- major surgery within 4 weeks,
- usage of drugs that significantly inhibit CYP3A4
Sites / Locations
- Children's Clinic Randers
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Budesonide
Montelukast
Outcomes
Primary Outcome Measures
Lower leg growth rate
Height
Secondary Outcome Measures
Full Information
NCT ID
NCT00380484
First Posted
September 25, 2006
Last Updated
February 19, 2008
Sponsor
Children´s Clinic, Randers
1. Study Identification
Unique Protocol Identification Number
NCT00380484
Brief Title
Short- and Long Term Growth in Children With Asthma
Official Title
Short- and Long Term Growth in Children With Asthma Treated With Budesonide or Montelukast
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Children´s Clinic, Randers
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess if treatment with budesonide 200 microgram per day affects short- or long term growth in children with asthma
Detailed Description
When children with asthma are treated with inhaled corticosteroids there is a risk of systemic adverse events such as growth suppression. It has been reported that treatment with budesonide 200 microgram per day does not affect short term growth in children with asthma. The aim of the present study is to assess if an unaffected short term growth means that also long term growth will be unaffected.
Short and long term growth in asthmatic children treated with budesonide will be compared with the growth in asthmatic children treated with montelukast.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Budesonide
Arm Title
2
Arm Type
Active Comparator
Arm Description
Montelukast
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
200µg daily
Intervention Type
Drug
Intervention Name(s)
Montelukast
Other Intervention Name(s)
Singulair
Intervention Description
5 mg daily
Primary Outcome Measure Information:
Title
Lower leg growth rate
Time Frame
one year
Title
Height
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 6-11,
prepubertal,
asthma,
normal weight and height,
informed consent
Exclusion Criteria:
treatment with systemic/inhaled/intranasal corticosteroids within the last week,
major surgery within 4 weeks,
usage of drugs that significantly inhibit CYP3A4
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole D Wolthers
Organizational Affiliation
Children's Clinic Randers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Clinic Randers
City
Randers
ZIP/Postal Code
8900
Country
Denmark
12. IPD Sharing Statement
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Short- and Long Term Growth in Children With Asthma
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