Pulmicort Asthma Prevention (Post-PAC)

Not Applicable

Completed

• Conditions: Asthma

• Registration Number: NCT00233584
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-04
• Study First Posted: 2005-10-06
• Primary Completion: 2006-05
• Study Completion: 2006-06
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-11
• Last Update Posted: 2008-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Success rate of the treatment algorithm: Frequency of protocol deviations, asthma exacerbations, different treatment steps.
Efficacy - development of lung function.

Secondary Outcome Measures

Name	Time	Method
Acceptability of the treatment algorithm by the parents.
Growth rate and BMD.
Exhaled nitrogen Oxide, bronchohyperresponsiveness.

Trial Locations

Locations (1)

Research Site; 🇩🇰 Copenhagen, Denmark