Status:
TERMINATED
Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
AstraZeneca
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the FDC...
Eligibility Criteria
Inclusion
- Moderate to severe COPD
- Smoking history of greater or equal to 10 pack-years
- Diagnosis of stable moderate to severe COPD as defined by the GOLD Guidelines
- Postbronchodilator FEV1 from 30% to 79% of predicted values, inclusive
- Postbronchodilator FEV1/FVC ratio \< 0.70
Exclusion
- History or presence of asthma, allergic rhinitis, or exercise-induced bronchospasm
- Hospitalization for an acute COPD exacerbation in the 3 months prior to study entry
- Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
- Eosinophil count of at least 600 cells/mm3
- Long term oxygen therapy \> 15 hours a day
Key Trial Info
Start Date :
June 30 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2008
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00706914
Start Date
June 30 2008
End Date
November 11 2008
Last Update
May 15 2017
Active Locations (40)
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1
Forest Investigative Site
Tucson, Arizona, United States, 85715
2
Forest Investigative Site
Tucson, Arizona, United States, 85741
3
Forest Investigative Site
Fullerton, California, United States, 92835
4
Forest Investigative Site
Lakewood, California, United States, 90712