Short- and Long Term Growth in Children With Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-02-29

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Budesonide

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

200µg daily

2

Montelukast

Group Type ACTIVE_COMPARATOR

Montelukast

Intervention Type DRUG

5 mg daily

Interventions

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Budesonide

200µg daily

Intervention Type DRUG

Montelukast

5 mg daily

Intervention Type DRUG

Other Intervention Names

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Singulair

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No