The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the Hispanic population...
Date First Received: January 5, 2007
Last Updated: March 20, 2008
Verified by: AstraZeneca, March 2008
Clinical Trial Phase: Phase 3 | Start Date: January 2007
Overall Status: Active, not recruiting
Estimated Enrollment: 240
Brief Summary
Official Title: “A 12-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre, Phase IIIB Study Comparing the Efficacy and Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily Versus Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily, in Adult/Adolescent (> 12 Yrs) Hispanic Subjects With Asthma”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the Hispanic population.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Budesonide/formoterol (SYMBICORT) pMDI
- Drug: Budesonide HFA pMDI
Outcome Measures for this Clinical Trial
Primary Measures
- To compare the efficacy of SYMBICORT pMDI 160/4.5 mg x 2 actuations bid to that of budesonide HFA pMDI 160 mg x 2 actuations bid, in Hispanic subjects with ICS dependent asthma.
- The primary efficacy variable will be morning Peak Expiratory Flow (AM PEF)
Secondary Measures
- To evaluate the safety of SYMBICORT pMDI compared to budesonide.
- To collect a peripheral blood sample for pharmacogenetic testing in consenting subjects for future pharmacogenetic analyses to be conducted outside the scope of the clinical study report
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Male or Female, Hispanic (self-reported), > 12 years of age
- Moderate to severe asthma requiring treatment with an inhaled corticosteroid
- Diagnosis of asthma for at least 6 months
Exclusion Criteria:
- Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
- Any significant disease or disorder that may jeopardize a subject's safety
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
Christer Hultquist, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00419757
Study ID Number: D5896C00021
ClinicalTrials.gov Identifier: NCT00419757
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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