Status:
COMPLETED
Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Chronic Obstructive Pulmonary Disease
Bronchitis
Eligibility:
All Genders
35+ years
Phase:
PHASE3
Brief Summary
To evaluate the long-term safety and monitor the long-term efficacy of arformoterol over a period of 6 months in subjects with chronic obstructive pulmonary disease (COPD).
Detailed Description
This is a double-blind, double-dummy, multicenter, randomized, active-controlled, parallel group, outpatient, safety study to evaluate the long term safety of arformoterol in the treatment of subjects...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria:
- Male and female subjects must be at least 35 years old at the time of consent
- Subjects must have a pre-established, documented primary clinical diagnosis of non-asthmatic COPD or are referred for diagnosis of non-asthmatic COPD
- Subjects must have a \>=15 pack-year smoking history and a baseline breathlessness severity grade of \>=2 (Modified Medical Research Council \[MMRC\] Dyspnea Scale Score) at Visits 1 and 2
- Female subjects \<=65 years of age must have a negative serum pregnancy test, females of childbearing potential must be using an acceptable method of birth control
- Subjects must be in general good health.
- Key Exclusion criteria:
- Subjects with a history of asthma, with the exception of asthma diagnosed in childhood
- Subjects with a blood eosinophil count \>5% of total white blood cell count
- Subjects have had a febrile illness within 72 hours (3 days) before Screening Visit 1
- Subjects with a chest x-ray that suggests a diagnosis other than COPD (e.g., diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions)
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
443 Patients enrolled
Trial Details
Trial ID
NCT00250679
Start Date
October 1 2005
End Date
October 1 2007
Last Update
June 4 2012
Active Locations (60)
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Birmingham, Alabama, United States
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Jasper, Alabama, United States
3
Mobile, Alabama, United States
4
Little Rock, Arkansas, United States