Short- and Long Term Growth in Children With Asthma

Short- and Long Term Growth in Children With Asthma Treated With Budesonide or Montelukast

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00380484

Enrollment

Registered

2006-09-26

Start date

2006-09-30

Completion date

2008-02-29

Last updated

2008-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

DRUGBudesonide

200µg daily

DRUGMontelukast

5 mg daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 11 Years

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

Design outcomes

Primary

Measure	Time frame
Lower leg growth rate	one year
Height	one year

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026