The objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring in patients with COPD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
196
Attn: William C. Bailey, M.D.
Birmingham, Alabama, United States
Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
Olive View UCLA Medical Center
Sylmar, California, United States
Trough FEV1 after 12 weeks of treatment
Time frame: 12 weeks
Trough FEV1 at Visit 3
Time frame: week 8
Trough FVC at Visits 3 and 4
Time frame: week 8 and week 12
FEV1 and FVC 90 min post study drug inhalation at all visits
Time frame: 90 minutes post-medication
Use of rescue medication
Time frame: 12 weeks
Patient's Global Evaluation
Time frame: week 8 and week 12
Physician's Global Evaluation
Time frame: week 8 and week 12
Health Related Quality of Life assessed by the EQ5D at Visit 2 and 4
Time frame: week 8 and week 12
Adverse events
Time frame: 12 weeks
Vital signs
Time frame: week 8 and week 12
Physical Exam
Time frame: week 12
12-lead ECG
Time frame: week 8 and week 12
24-hour holter ECG monitoring
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Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, United States
Respiratory Diseases (111A)
Bay Pines, Florida, United States
Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho, United States
LSU Health Sciences Center
Shreveport, Louisiana, United States
Pulmonary and Critical Care Services, PC
Albany, New York, United States
The Oregon Clinic
Portland, Oregon, United States
...and 2 more locations
Time frame: week 8 and week 12