Efficacy of Symbicort pMDI Administered Once Daily in Adolescents and Adults During 12 Weeks - STEM
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 and placebo (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 a dose of Symbicort taken once daily with other
dosage regimens of Symbicort , budesonide and placebo for the treatment of asthma in
adolescents and adults
Clinical Details
Official title: A 12 Week, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled Study of Symbicort pMDI Administered Once Daily in Adults and Adolescents With Asthma - STEM
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in evening PEF
Secondary outcome: Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomesHealth-related quality of life Routine safety assessments
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of asthma and baseline lung function tests as determined by the protocol
- Required and received treatment with inhaled corticosteroids within the timeframe and
doses specified in the protocol
Exclusion Criteria:
- Severe asthma
- Has required treatment with any non-inhaled corticosteroids within previous 4 weeks,
has sensitivity to drugs specified in protocol or requires treatment with
beta-blockers
Locations and Contacts
Additional Information
Starting date: April 2003
Ending date: August 2004
Last updated: April 2, 2008
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