PreAsthmaControl (PAC)

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00234390

First received: October 5, 2005

Last updated: January 21, 2011

Last verified: January 2011

History of Changes

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Prevention of Asthma in Infants/Young Children - PAC

Resource links provided by NLM:

Drug Information available for: Budesonide

U.S. FDA Resources

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
Study Completion Date:	December 2004

Eligibility


Ages Eligible for Study:	up to 6 Months (Child)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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.


ClinicalTrials.gov Identifier:	NCT00234390 History of Changes
Other Study ID Numbers:	SD-004-0299
Study First Received:	October 5, 2005
Last Updated:	January 21, 2011
Health Authority:	Denmark: Danish Medicines Agency

Additional relevant MeSH terms:


Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide	Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 26, 2016

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