Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pulmicort Asthma Prevention (Post-PAC)

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: October 4, 2005
Last updated: January 11, 2008
Last verified: January 2008

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
Procedure: Pulmicort (budesonide) pMDI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
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
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 identifier: NCT00233584

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

No publications provided Identifier: NCT00233584     History of Changes
Other Study ID Numbers: D5254C00004
Study First Received: October 4, 2005
Last Updated: January 11, 2008
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by AstraZeneca:
Children of asthmatic mothers

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases processed this record on February 27, 2015