NCT00380484

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

February 27, 2008

Status Verified

February 1, 2008

Enrollment Period

1.4 years

First QC Date

September 25, 2006

Last Update Submit

February 19, 2008

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

  • Lower leg growth rate

    one year

  • Height

    one year

Study Arms (2)

1

EXPERIMENTAL

Budesonide

Drug: Budesonide

2

ACTIVE COMPARATOR

Montelukast

Drug: Montelukast

Interventions

BudesonideDRUG

200µg daily

1
MontelukastDRUG

5 mg daily

Also known as: Singulair
2

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age 6-11,
  • prepubertal,
  • asthma,
  • normal weight and height,
  • informed consent

You may not qualify if:

  • treatment with systemic/inhaled/intranasal corticosteroids within the last week,
  • major surgery within 4 weeks,
  • usage of drugs that significantly inhibit CYP3A4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Clinic Randers

Randers, 8900, Denmark

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonidemontelukast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Ole D Wolthers

    Children's Clinic Randers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2006

First Posted

September 26, 2006

Study Start

September 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

February 27, 2008

Record last verified: 2008-02

Locations

DK(1)