Short- and Long Term Growth in Children With Asthma

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Montelukast; Drug: Budesonide

• Registration Number: NCT00380484
• Lead Sponsor: Children´s Clinic, Randers

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-25
• Study First Submitted QC: 2006-09-25
• Study First Posted: 2006-09-26
• Status Verified: 2008-02
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Last Update Submitted: 2008-02-19
• Last Update Posted: 2008-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• age 6-11,
• prepubertal,
• asthma,
• normal weight and height,
• informed consent

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Exclusion Criteria

• treatment with systemic/inhaled/intranasal corticosteroids within the last week,
• major surgery within 4 weeks,
• usage of drugs that significantly inhibit CYP3A4

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Montelukast	Montelukast
1	Budesonide	Budesonide

Primary Outcome Measures

Name	Time	Method
Lower leg growth rate	one year
Height	one year

Trial Locations

Locations (1)

Children's Clinic Randers; 🇩🇰 Randers, Denmark