Status:
COMPLETED
A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.
Eligibility Criteria
Inclusion
- A current clinical diagnosis of COPD with COPD symptoms for more than 2 years
- Current smoker or smoking history of 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year)
- A history of at least 1 COPD exacerbations requiring a course of steroids and/or antibiotics within 1-12 months before the first visit
Exclusion
- A history of asthma at or after 18 years of age
- A history of allergic rhinitis at or after 18 years of age
- Subjects taking oral steroids
- Any significant disease or disorder that may jeopardize a subject's safety
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00419744
Start Date
January 1 2007
End Date
August 1 2009
Last Update
September 16 2010
Active Locations (140)
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1
Research Site
Jasper, Alabama, United States
2
Research Site
Mobile, Alabama, United States
3
Research Site
Tucson, Arizona, United States
4
Research Site
Fort Smith, Arkansas, United States