drugset / Trial / NCT00641472

Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

NCT00641472

Phase 4 Completed 380 enrolled AstraZeneca
RandomizedParallel-groupOpen-labelTreatment

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 children with asthma aged 2 to 8. If allocated to SINGULAR treatment, children aged between 2 and 5 will receive 4mg strength SINGULAR and those aged between 6 and 8 will receive 5mg strength SINGULAR.

Timeline

Start
2002-10
Primary completion
2005-02
Completion
2005-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 0.5 mg
Comparator Montelukast Other / unclassified 4 mg
Comparator Montelukast Other / unclassified 5 mg

Indications