Official Title: “An Evaluation of the Effectiveness of Pulmicort Respules (Budesonide Inhalation Suspension) Versus SINGULAIR (Montelukast Sodium) in Children 2-8 Years Old With Asthma Requiring Controller Therapy.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2005

Intervention(s) in this Clinical Trial

• Drug: Budesonide inhalation suspension
  • 0.5mg
• Drug: Montelukast Sodium
  • 4mg or 5mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Budesonide inhalation suspension
• Active Comparator: 2
  • Montelukast sodium

Primary Measures

• Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids
  • Time Frame: Each clinic visit
    

Secondary Measures

• Incidence and Severity of Adverse Events
  • Time Frame: Each clinic visit
    
• Time to 1st additional asthma medication measured at 12 weeks and 26 weeks
  • Time Frame: Each clinic visit
    
• Time to 1st acute severe exacerbation (as measured by the need for oral steroids), measured at 12 weeks, 26 weeks, and 52 weeks
  • Time Frame: Each clinic visit
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 8 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Bertil Andersson Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00641472

Study ID Number: DX-RES-2103

ClinicalTrials.gov Identifier: NCT00641472

Health Authority: United States: Food and Drug Administration