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Pulmicort Asthma Prevention (Post-PAC)

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ClinicalTrials.gov Identifier: NCT00233584
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : January 14, 2008
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Asthma Procedure: Pulmicort (budesonide) pMDI Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
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)
Study Start Date : July 2001
Actual Primary Completion Date : May 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide
U.S. FDA Resources




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

Secondary Outcome Measures :
  1. Acceptability of the treatment algorithm by the parents.
  2. Growth rate and BMD.
  3. Exhaled nitrogen Oxide, bronchohyperresponsiveness.


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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
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.

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


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

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

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
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists