Status:
COMPLETED
Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Chronic Obstructive Pulmonary Disease
Bronchitis
Eligibility:
All Genders
45+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic...
Detailed Description
This study is a multicenter, randomized, modified-blind, double-dummy two-week parallel-group efficacy and safety study of arformoterol tartrate inhalation solution twice daily, tiotropium inhalation ...
Eligibility Criteria
Inclusion
- Male and female subjects must be at least 45 years old at the time of consent.
- Subjects must have a pre-established primary clinical diagnosis of COPD.
- Subjects must have a baseline FEV1 of ≤65% of predicted normal value at Visit 1.
- Subjects must have a FEV1 ≥ 0.70L at Visit 1.
Exclusion
- Subjects who do not have a FEV1/forced vital capacity (FVC) ratio of ≤70% at Visit 1.
- Subjects who do not have a ³15 pack-year smoking history and a baseline breathlessness severity grade of ³2 (Modified Medical Research Council \[MMRC\] Dyspnea Scale Score) at Visit 1.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT00424528
Start Date
December 1 2006
End Date
October 1 2007
Last Update
June 4 2012
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
Jasper, Alabama, United States, 35501
2
Tucson, Arizona, United States, 85715
3
San Diego, California, United States, 92120
4
Colorado Springs, Colorado, United States, 80909