Symbicort in Asthmatic Children - SEEDLING
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: budesonide/formoterol (Drug); budesonide (Drug); formoterol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Catherine Bonuccelli, Study Director, Affiliation: AstraZeneca
Summary
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
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Morning PEF
Secondary outcome: Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments
Eligibility
Minimum age: 6 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: July 2002
Ending date: December 2003
Last updated: April 1, 2008
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