The objective of the study was to evaluate the degree of improvement in lung function in patients with chronic obstructive pulmonary disease (COPD) after treatment with tiotropium inhalation capsules compared to salmeterol inhalation aerosol .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
653
FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12)
Time frame: 12 weeks
peak FEV1
Time frame: 12 weeks
Trough FEV1: Trough FEV1 was the FEV1 measured prior to dosing
Time frame: 12 weeks
Trough and peak FVC and FVC AUC0-12 measured at the same times as FEV1 on each test day
Time frame: 12 weeks
Individual FEV1 and FVC measurements at each timepoint
Time frame: 12 weeks
Number (%) of patients with at least one exacerbation of COPD
Time frame: 12 weeks
time to first exacerbation
Time frame: 12 weeks
number of exacerbations
Time frame: 12 weeks
number of exacerbation days
Time frame: 12 weeks
Average daily occasions of rescue medication [albuterol (salbutamol)] use each week
Time frame: 12 weeks
All adverse events
Time frame: 12 weeks
Pulse rate measured in conjunction with spirometry
Time frame: 12 weeks
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UAB Medical Center
Birmingham, Alabama, United States
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Jasper, Alabama, United States
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Phoenix, Arizona, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
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Fullerton, California, United States
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Sepulveda, California, United States
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Sylmar, California, United States
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Boulder, Colorado, United States
Colorado Pulmonary Associates
Denver, Colorado, United States
Boehringer Ingelheim Investigational Site
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...and 40 more locations
Blood pressure (seated) measured in conjunction with spirometry
Time frame: 12 weeks