PreAsthmaControl (PAC) - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00234390

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: Pulmicort (budesonide) pMDI	Phase III

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prevention of Asthma in Infants/Young Children - PAC

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	400
Study Start Date:	November 1998

Eligibility

Ages Eligible for Study:	up to 6 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234390

Locations

Denmark
Research Site
Copenhagen, Denmark

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca AB CNS Medical Science Director, MD

AstraZeneca

More Information

Publications of Results:

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.

Study ID Numbers:	SD-004-0299
Study First Received:	October 5, 2005
Last Updated:	August 11, 2006
ClinicalTrials.gov Identifier:	NCT00234390
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Budesonide
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009