Back to resultsPulmicort Asthma Prevention (Post-PAC)
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pulmicort (budesonide) pMDI
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Children of asthmatic mothers
Eligibility 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.
Sites / Locations
- Research Site
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00233584
Brief Title
Pulmicort Asthma Prevention (Post-PAC)
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 Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Children of asthmatic mothers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Pulmicort (budesonide) pMDI
Primary Outcome Measure Information:
Title
Success rate of the treatment algorithm: Frequency of protocol deviations, asthma exacerbations, different treatment steps.
Title
Efficacy - development of lung function.
Secondary Outcome Measure Information:
Title
Acceptability of the treatment algorithm by the parents.
Title
Growth rate and BMD.
Title
Exhaled nitrogen Oxide, bronchohyperresponsiveness.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Denmark Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Pulmicort Asthma Prevention (Post-PAC)
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