NCT00233584
Completed
Not Applicable
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)
ConditionsAsthma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- AstraZeneca
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Success rate of the treatment algorithm: Frequency of protocol deviations, asthma exacerbations, different treatment steps.
- Status
- Completed
- Last Updated
- 18 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Success rate of the treatment algorithm: Frequency of protocol deviations, asthma exacerbations, different treatment steps.
Efficacy - development of lung function.
Secondary Outcomes
- Acceptability of the treatment algorithm by the parents.
- Growth rate and BMD.
- Exhaled nitrogen Oxide, bronchohyperresponsiveness.
Study Sites (1)
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