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Pulmicort Asthma Prevention (Post-PAC)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 6, 2005
Last Update Posted: January 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

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)

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233584

Research Site
Copenhagen, Denmark
Sponsors and Collaborators
Study Director: AstraZeneca Denmark Medical Director, MD AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00233584     History of Changes
Other Study ID Numbers: D5254C00004
First Submitted: October 4, 2005
First Posted: October 6, 2005
Last Update Posted: January 14, 2008
Last Verified: January 2008

Keywords provided by AstraZeneca:
Children of asthmatic mothers

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists