Pulmicort Asthma Prevention (Post-PAC)
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Pulmicort (budesonide) pMDI (Procedure)
Phase: N/A
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Denmark Medical Director, MD, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Success rate of the treatment algorithm: Frequency of protocol deviations, asthma exacerbations, different treatment steps.Efficacy - development of lung function.
Secondary outcome: Acceptability of the treatment algorithm by the parents.Growth rate and BMD. Exhaled nitrogen Oxide, bronchohyperresponsiveness.
Eligibility
Minimum age: N/A.
Maximum age: 6 Years.
Gender(s): Both.
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.
Locations and Contacts
Research Site, Copenhagen, Denmark
Additional Information
Starting date: July 2001
Ending date: June 2006
Last updated: January 11, 2008
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