Status:
COMPLETED
Long-Term Safety of Symbicort in Asthmatic Children - SAPLING
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
6-11 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11 years
Eligibility Criteria
Inclusion
- At least 6 and maximally 11 years of age
- Diagnosis of asthma
- Baseline lung function tests as determined by protocol and required and received daily treatment with inhaled corticosteroids for at least 4 weeks prior to study start
Exclusion
- Has required treatment with any non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
- Has had cancer in the previous 5 years or has a significant disease that may put the patient at risk in this study
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2003
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00646529
Start Date
July 1 2002
End Date
October 1 2003
Last Update
March 30 2009
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