Pulmicort Asthma Prevention (Post-PAC)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00233584
First received: October 4, 2005
Last updated: January 11, 2008
Last verified: January 2008
  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

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)
  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
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: NCT00233584

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

No publications provided

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

ClinicalTrials.gov processed this record on July 24, 2014