Symbicort in Asthmatic Children - SEEDLING

Verified by: AstraZeneca, March 2009
First Received: April 1, 2008 | Last Updated: March 27, 2009 | Phase: Phase 3 | Start Date: July 2002
Overall Status: Completed | Estimated Enrollment: 405
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The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone in the treatment of asthma in children aged 6 to 11...

Brief Summary

Official Title: “A 12 Week Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of Symbicort TM (40/4.5 Mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Asthmatic Children Aged Six to Eleven Years - SEEDLING 40/4.5”

The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone in the treatment of asthma in children aged 6 to 11 years

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Drug: budesonide/formoterol
  • Drug: budesonide
  • Drug: formoterol

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Active Comparator: 2
  • Active Comparator: 3

Outcome Measures for this Clinical Trial

Primary Measures

  • Morning PEF
    • Time Frame: Daily

Secondary Measures

  • Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments
    • Time Frame: Throughout the treatment period

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Baseline lung function tests results as determined by the protocol
  • Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria:

  • Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
  • Has been hospitalised or required emergency treatment for asthma-related condition within previous 6 months
  • Has had cancer within previous 5 years or has a significant disease, as judged by investigator, 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 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00651547

Study ID Number: SD-039-0718

ClinicalTrials.gov Identifier: NCT00651547

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00651547