Short- and Long Term Growth in Children With Asthma

Overview[ - collapse ][ - ]

Purpose 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
ConditionAsthma
InterventionDrug: Budesonide
Drug: Montelukast
PhasePhase 4
SponsorChildren´s Clinic, Randers
Responsible PartyChildren´s Clinic, Randers
ClinicalTrials.gov IdentifierNCT00380484
First ReceivedSeptember 25, 2006
Last UpdatedFebruary 19, 2008
Last verifiedFebruary 2008

Tracking Information[ + expand ][ + ]

First Received DateSeptember 25, 2006
Last Updated DateFebruary 19, 2008
Start DateSeptember 2006
Estimated Primary Completion DateFebruary 2008
Current Primary Outcome Measures
  • Lower leg growth rate [Time Frame: one year]
  • Height [Time Frame: one year]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleShort- and Long Term Growth in Children With Asthma
Official TitleShort- and Long Term Growth in Children With Asthma Treated With Budesonide or Montelukast
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.
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
ConditionAsthma
InterventionDrug: Budesonide
200µg daily
Drug: Montelukast
5 mg daily
Other Names:
Singulair
Study Arm (s)
  • Experimental: 1
    Budesonide
  • Active Comparator: 2
    Montelukast

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment52
Estimated Completion DateFebruary 2008
Estimated Primary Completion DateFebruary 2008
Eligibility Criteria
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
GenderBoth
Ages6 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesDenmark

Administrative Information[ + expand ][ + ]

NCT Number NCT00380484
Other Study ID NumbersBKR-KNAST-06
Has Data Monitoring CommitteeNot Provided
Information Provided ByChildren´s Clinic, Randers
Study SponsorChildren´s Clinic, Randers
CollaboratorsNot Provided
Investigators Principal Investigator: Ole D Wolthers Children's Clinic Randers
Verification DateFebruary 2008

Locations[ + expand ][ + ]

Children's Clinic Randers
Randers, Denmark, 8900