Short- and Long Term Growth in Children With Asthma

Children´s Clinic, Randers

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Budesonide; Drug: Montelukast

Study type: Interventional

Funder types: Other

Identifiers

NCT00380484

EudractCT-nr 2006-003013-41

BKR-KNAST-06

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

1

Experimental group

Description:

Budesonide

Treatment:

Drug: Budesonide

2

Active Comparator group

Description:

Montelukast

Treatment:

Drug: Montelukast