Pulmicort Asthma Prevention (Post-PAC) - Tabular View

Tracking Information

First Received Date ^ICMJE

October 4, 2005

Last Updated Date

January 11, 2008

Start Date ^ICMJE

July 2001

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00233584 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Pulmicort Asthma Prevention (Post-PAC)

Official Title ^ICMJE

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)

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Procedure: Pulmicort (budesonide) pMDI

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

June 2006

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

up to 6 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00233584

Responsible Party

Study ID Numbers ^ICMJE

D5254C00004

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca Denmark Medical Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP