PreAsthmaControl (PAC)

Asthma Clinical Trial

Official title:

Prevention of Asthma in Infants/Young Children - PAC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234390
• Other study ID #: SD-004-0299
• Status: Completed
• Phase: Phase 4
• First received: October 5, 2005
• Last updated: January 21, 2011
• Start date: November 1998
• Est. completion date: December 2004

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Pulmicort (budesonide) pMDI

Locations

Country	Name	City	State
Denmark	Research Site	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Denmark, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptom free days
Primary	days with no use of bronchodilator
Primary	days with no use of bronchodilator and no symptoms
Primary	number of treated episodes
Primary	number of treatment with add-on medication
Secondary	asthma status
Secondary	time to start of algorithm treatment
Secondary	the total steroid dose
Secondary	First treatment episode:
Secondary	number of symptom days
Secondary	number of days with use of bronchodilator
Secondary	number of patients who needed add-on medication
Secondary	BMD
Secondary	height
Secondary	serious adverse events