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Clinical InvestigationsCOPDImprovement in Resting Inspiratory Capacity and Hyperinflation With Tiotropium in COPD Patients With Increased Static Lung Volumes*
Section snippets
Study Design
This was a randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy of tiotropium in patients with COPD. The first clinic visit was for screening of patients. Qualified patients were asked to return within 2 weeks for the baseline visit. If they continued to meet inclusion/exclusion criteria, they were randomized to receive one capsule daily of tiotropium, 18 μg, or placebo through the HandiHaler device (Boehringer Ingelheim; Ridgefield, CT) for 28
Results
A total of 128 patients were screened and signed informed consent, and 81 patients were randomized and entered the study. Of the 81 randomized patients, 75 patients completed the study. Of the six patients withdrawn after randomization, one patient from each treatment group withdrew due to worsening COPD. The other withdrawals were due to protocol violations.
Discussion
COPD is a disease characterized by the presence of incompletely reversible airflow limitation.15 In moderate-to-severe COPD, this airflow limitation is usually associated with gas trapping and hyperinflation as assessed objectively through an increase in TGV. This hyperinflation is also reflected by a reduction in IC. These physiologic abnormalities translate to symptoms of dyspnea, exercise intolerance, and patient disability.516 To this end, it is now accepted that while spirometric
ACKNOWLEDGMENT
We thank our co-investigators, Dr. D. Mahler, Dr. E. Diamond, Dr. C. Cote, and Dr. D. Maple.
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Drs. Celli and ZuWallack are consultants for Boehringer Ingelheim.
This study was financed by Boehringer Ingelheim, Inc.