Status:
COMPLETED
A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and Symbicort® pMDI 2 x 80/4.5 μg Bid With Formoterol Turbuhaler®, Budesonide pMDI, the Combination of Formoterol Turbuhaler® and Budesonide pMDI, and Placebo in COPD Patients
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-ter...
Eligibility Criteria
Inclusion
- A clinical diagnosis of COPD with symptoms for more than 2 years
- Smoking history of 10 or more pack years
- A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.
Exclusion
- A history of asthma
- Patients taking oral steroids.
- Any significant disease or disorder that may jeopardize the safety of the patient
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT00206154
Start Date
April 1 2005
End Date
December 1 2006
Last Update
March 27 2009
Active Locations (212)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Jasper, Alabama, United States
3
Research Site
Mobile, Alabama, United States
4
Research Site
Glendale, Arizona, United States