Status:
COMPLETED
Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
2-8 years
Phase:
PHASE4
Brief Summary
A one year study comparing the safety and effectiveness of Pulmicort (0.5mg strength given once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the evening) in childr...
Eligibility Criteria
Inclusion
- Aged 2 to 8 at study entry
- At least 3 episodes of wheezing in the previous year that lasted more than 24 hours and affected sleep or symptoms of mild persistent asthma
- use of b-2 agonist treatment on at least 3 of 7 consecutive days or run in
Exclusion
- Severe or unstable asthma
- any significant finding at a physical exam
- an exacerbation of asthma in the 30 days before entering the study that might affect study results in judgement of the study doctor
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2005
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT00641472
Start Date
October 1 2002
End Date
February 1 2005
Last Update
March 25 2009
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