NCT00233584

Brief Summary

This prospective study will evaluate the feasibility of the defined decision tree for the treatment of asthmatic young children. Children who develop episode (=3 consecutive days) of any troublesome lower respiratory symptoms are treated according to a strictly pre-defined multi-steps treatment algorithm until the age of 6 years.

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 not_applicable asthma

Timeline
Completed

Started Jul 2001

Longer than P75 for not_applicable 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

January 14, 2008

Status Verified

January 1, 2008

Enrollment Period

4.8 years

First QC Date

October 4, 2005

Last Update Submit

January 11, 2008

Conditions

Asthma

Keywords

Children of asthmatic mothers

Outcome Measures

Primary Outcomes (2)

  • Success rate of the treatment algorithm: Frequency of protocol deviations, asthma exacerbations, different treatment steps.

  • Efficacy - development of lung function.

Secondary Outcomes (3)

  • Acceptability of the treatment algorithm by the parents.

  • Growth rate and BMD.

  • Exhaled nitrogen Oxide, bronchohyperresponsiveness.

Interventions

Pulmicort (budesonide) pMDIPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Children form the COPSAC/PAC study with episodes of troublesome respiratory symptoms. Episodes are defined as 3 consecutive days of any troublesome lower respiratory symptoms.

You may not qualify if:

  • Differential diagnoses including at least a chest x-ray and sweat test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Copenhagen, Denmark

Location

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 Denmark Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 6, 2005

Study Start

July 1, 2001

Primary Completion

May 1, 2006

Study Completion

June 1, 2006

Last Updated

January 14, 2008

Record last verified: 2008-01

Locations

DK(1)