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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2003

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

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
    

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

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Catherine Bonuccelli Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on November 20, 2008

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