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Completed

NCT Number: NCT00380484

Short- and Long Term Growth in Children With Asthma

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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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Clinic Randers

Randers, 8900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide

Drug

200µg daily

Montelukast

Drug

5 mg daily

Other names: Singulair

Primary outcomes

  1. Lower leg growth rate

    Time frame: one year

  2. Height

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Children´s Clinic, Randers

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 26, 2006
Registry last updated
Feb 27, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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