Pulmicort Asthma Prevention (Post-PAC) - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00233584

Purpose

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.

Condition	Intervention
Asthma	Procedure: Pulmicort (budesonide) pMDI

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Study to Evaluate the Feasibility of a Treatment Algorithm in Newly Diagnosed Asthmatic Children. An Open Follow-up to Asthma Prevention in Infants/Young Children (PAC)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	400
Study Start Date:	July 2001
Study Completion Date:	June 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233584

Locations

Denmark
Research Site
Copenhagen, Denmark

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Denmark Medical Director, MD

AstraZeneca

More Information

Study ID Numbers:	D5254C00004
Study First Received:	October 4, 2005
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00233584
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by AstraZeneca:

Children of asthmatic mothers

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:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents

Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009