Symbicort Onset of Action 1
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); fluticasone/salmeterol (Advair Diskus) (Drug); albuterol (Ventolin) (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 (Subject, Caregiver, Investigator), 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:
- Diagnosis of asthma and baseline lung function test results as determined by protocol
- Required and received asthma maintenance therapy within previous 4 weeks at doses
determined by protocol
Exclusion Criteria:
- Severe asthma or asthma markedly affected by seasonal factors
- Has required treatment with any non-inhaled corticosteroids within previous 4 weeks,
has sensitivity to drugs specified in the protocol or requires treatment with
beta-blockers
Locations and Contacts
Additional Information
Starting date: April 2003
Ending date: December 2003
Last updated: March 27, 2008
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