Long-Term Safety of Symbicort in Asthmatic Children - SAPLING
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 (Symbicort) (Drug); budesonide (Pulmicort) (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 assess the safety of Symbicort compared to Pulmicort in
asthmatic children aged 6 to 11 years
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
Primary outcome: Long term safety profile of Symbicort compared to Pulmicort as determined by safety assessments detailed in the protocol
Secondary outcome: Compare health economic outcomes and quality of life between patients treated with Symbicort and Pulmicort
Eligibility
Minimum age: 6 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: July 2002
Ending date: January 2004
Last updated: March 27, 2008
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