Short- and Long Term Growth in Children With Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380484
• Other study ID #: BKR-KNAST-06
• Secondary ID: EudractCT-nr 200
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2006
• Last updated: February 19, 2008
• Start date: September 2006
• Est. completion date: February 2008

Study information

• Verified date: February 2008
• Source: Children´s Clinic, Randers
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide
200µg daily
• Montelukast
5 mg daily

Locations

Country	Name	City	State
Denmark	Children's Clinic Randers	Randers

Sponsors (1)

Lead Sponsor	Collaborator
Children´s Clinic, Randers

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower leg growth rate		one year
Primary	Height		one year