Status:
COMPLETED
Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries duri...
Eligibility Criteria
Inclusion
- Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms
- Current or previous smoker with a smoking history of 10 or more pack years
- Lung function parameters: FEV1/FVC \< 70%, post-bronchodilator and post-bronchodilator FEV1 \< 80% of predicted normal value
Exclusion
- History and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis
- Use of inhaled glucocorticosteroids within 4 weeks prior to Visit 2
- Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
613 Patients enrolled
Trial Details
Trial ID
NCT00628862
Start Date
December 1 2007
End Date
April 1 2009
Last Update
October 25 2012
Active Locations (47)
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1
Research Site
Gabrovo, Bulgaria
2
Research Site
Lovech, Bulgaria
3
Research Site
Pleven, Bulgaria
4
Research Site
Rousse, Bulgaria