Symbicort Onset of Action 2
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); fluticasone/salmeterol (Drug); albuterol (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 the early onset of effect of Symbicort compared to
Advair Diskus and Ventolin in adults with asthma
Clinical Details
Official title: A Randomized, Multicenter, Placebo and Active-Controlled, Single-Dose, 4-Period, Crossover Study to Evaluate the Bronchodilating Effect of SYMBICORT pMDI Versus Advair Diskus and Ventolin HFA.
Study design: Treatment, Randomized, Double-Blind, Crossover Assignment, Efficacy Study
Primary outcome: FEV1 3 minutes post dose
Secondary outcome: 12 hour serial FEV1Patients perception of effect
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- At least 18 years of age
- Diagnosis of asthma and baseline lung function test results as determined by the
protocol
- Required and received inhaled corticosteroids within timeframe and doses specified in
the protocol
Exclusion Criteria:
- Severe asthma or asthma that is markedly effected by seasonal factors
- Has required and received non-inhaled corticosteroids within the previous 4 weeks, has
sensitivity to drugs specified in the protocol or requires treatment with
beta-blockers
Locations and Contacts
Additional Information
Starting date: March 2003
Ending date: October 2003
Last updated: March 26, 2008
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