NCT00234390

Brief Summary

The purpose of this study is to investigate the ability of budesonide, given during episodes of troublesome lung symptoms to reduce further symptoms in infants and young children at risk of developing asthma

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_4 asthma

Timeline
Completed

Started Nov 1998

Longer than P75 for phase_4 asthma

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

November 1, 1998

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2005

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

First QC Date

October 5, 2005

Last Update Submit

January 21, 2011

Conditions

Asthma

Outcome Measures

Primary Outcomes (5)

  • symptom free days

  • days with no use of bronchodilator

  • days with no use of bronchodilator and no symptoms

  • number of treated episodes

  • number of treatment with add-on medication

Secondary Outcomes (10)

  • asthma status

  • time to start of algorithm treatment

  • the total steroid dose

  • First treatment episode:

  • number of symptom days

  • +5 more secondary outcomes

Interventions

Pulmicort (budesonide) pMDIDRUG

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children of asthmatic mothers form the COPSAC birth cohort study

You may not qualify if:

  • Children born more than 4 weeks preterm
  • children with other systemic illness that atopy/allergy
  • Children requiring mechanical ventilation at any time since birth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Copenhagen, Denmark

Location

Related Publications (1)

  • Bisgaard H, Hermansen MN, Loland L, Halkjaer LB, Buchvald F. Intermittent inhaled corticosteroids in infants with episodic wheezing. N Engl J Med. 2006 May 11;354(19):1998-2005. doi: 10.1056/NEJMoa054692.

    PMID: 16687712RESULT

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • AstraZeneca AB CNS Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 5, 2005

First Posted

October 7, 2005

Study Start

November 1, 1998

Study Completion

December 1, 2004

Last Updated

January 24, 2011

Record last verified: 2011-01

Locations

DK(1)