Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Budesonide; Montelukast

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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