PreAsthmaControl (PAC)

Phase 4

Completed

• Conditions: Asthma

• Registration Number: NCT00234390
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 1998-11
• Study Completion: 2004-12
• Study First Submitted: 2005-10-05
• Study First Submitted QC: 2005-10-05
• Study First Posted: 2005-10-07
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

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

Inclusion Criteria

• Children of asthmatic mothers form the COPSAC birth cohort study

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
days with no use of bronchodilator and no symptoms
number of treated episodes
number of treatment with add-on medication
days with no use of bronchodilator
symptom free days

Secondary Outcome Measures

Name	Time	Method
asthma status
number of patients who needed add-on medication
BMD
height
the total steroid dose
First treatment episode:
number of symptom days
time to start of algorithm treatment
number of days with use of bronchodilator
serious adverse events

Trial Locations

Locations (1)

Research Site; 🇩🇰 Copenhagen, Denmark