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Clinical Trials/NCT00233584
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)

AstraZeneca1 site in 1 country400 target enrollmentJuly 2001
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.

Registry
clinicaltrials.gov
Start Date
July 2001
End Date
June 2006
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

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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