Official Title: “A Six Month, Randomized, Open-Label, Safety Study of Symbicort (160/4.5mcg) Compared to Pulmicort Turbuhaler in Asthmatic Children Aged Six to Eleven Years - SAPLING”

The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11 years

Study Type: Interventional

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

Study Primary Completion Date: October 2003

Intervention(s) in this Clinical Trial

• Drug: budesonide/formoterol (Symbicort)
• Drug: budesonide (Pulmicort)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • budesonide/formoterol
• Active Comparator: 2
  • budesonide

Primary Measures

• Long term safety profile of Symbicort compared to Pulmicort as determined by safety assessments detailed in the protocol
  • Time Frame: 4 assessments within 26 week treatment period
    

Secondary Measures

• Compare health economic outcomes and quality of life between patients treated with Symbicort and Pulmicort
  • Time Frame: 4 assessments within 26 week treatment period
    

Inclusion Criteria:

• 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 Criteria:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 11 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Catherine Bonuccelli Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00646529

Study ID Number: SD-039-0719

ClinicalTrials.gov Identifier: NCT00646529

Health Authority: United States: Food and Drug Administration