Short- and Long Term Growth in Children With Asthma

February 19, 2008 updated by: Children´s Clinic, Randers

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Randers, Denmark, 8900
        • Children's Clinic Randers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Budesonide
Drug: Budesonide
200µg daily
Active Comparator: 2
Montelukast
Drug: Montelukast
5 mg daily
Other Names:
  • Singulair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lower leg growth rate
Time Frame: one year
one year
Height
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children´s Clinic, Randers

Investigators

  • Principal Investigator: Ole D Wolthers, Children's Clinic Randers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 25, 2006

First Submitted That Met QC Criteria

September 25, 2006

First Posted (Estimate)

September 26, 2006

Study Record Updates

Last Update Posted (Estimate)

February 27, 2008

Last Update Submitted That Met QC Criteria

February 19, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BKR-KNAST-06
  • EudractCT-nr 2006-003013-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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