Long-Term Safety of Symbicort in Asthmatic Children - SAPLING

Verified by: AstraZeneca, March 2009
First Received: March 26, 2008 | Last Updated: March 27, 2009 | Phase: Phase 3 | Start Date: July 2002
Overall Status: Completed | Estimated Enrollment: 175
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The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Catherine Bonuccelli Study Director AstraZeneca  

Additional Information

Information obtained from ClinicalTrials.gov on February 08, 2012

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

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00646529