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The primary objective of this trial is to determine whether treatment with tiotropium (18 mcg) capsule once daily via the HandiHaler reduces the proportion of patients with COPD experiencing an exacerbation and the proportion of patients hospitalized for an exacerbation during a six month observation period.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients experiencing an exacerbation | 6 months | |
| Percentage of patients hospitalized for a COPD exacerbation | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first COPD exacerbation | 6 months | |
| Time to first hospitalization associated with an COPD exacerbation | 6 months | |
| Total number of days of corticosteroids for an COPD exacerbation |
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |||
| Carl T. Hayden VA Medical Center |
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| 6 months |
| Total number of antibiotics for an COPD exacerbation | 6 months |
| Number of unscheduled out-patient visits | 6 months |
| Total number of hospital admissions and total hospital days | 6 months |
| Trough post-dose FEV1 and FVC | after 3 and 6 months |
| 90 minute post-dose FEV1 and FVC | after 3 and 6 months |
| Occurrence of serious adverse events | 6 months |
| Phoenix |
| Arizona |
| United States |
| Southern Arizona VA Health Care System | Tuscon | Arizona | United States |
| VA Long Beach Healthcare System | Long Beach | California | United States |
| Boehringer Ingelheim Investigational Site | Palo Alto | California | United States |
| Respiratory Diseases (111A) | Bay Pines | Florida | United States |
| J. Hillis Miller Health Center | Gainesville | Florida | United States |
| Veteran Affairs Medical Center | Hines | Illinois | United States |
| Veterans Affairs Medical Center | North Chicago | Illinois | United States |
| Boehringer Ingelheim Investigational Site | Indianapolis | Indiana | United States |
| Boehringer Ingelheim Investigational Site | Lexington | Kentucky | United States |
| 4720 I-10 Service Road | Metairie | Louisiana | United States |
| Boehringer Ingelheim Investigational Site | Boston | Massachusetts | United States |
| Veteran Affairs Medical Center | Minneapolis | Minnesota | United States |
| Boehringer Ingelheim Investigational Site | Kansas City | Missouri | United States |
| Boehringer Ingelheim Investigational Site | Omaha | Nebraska | United States |
| Boehringer Ingelheim Investigational Site | Reno | Nevada | United States |
| Boehringer Ingelheim Investigational Site | Buffalo | New York | United States |
| Bronx VA Medical Center | New York | New York | United States |
| Boehringer Ingelheim Investigational Site | Durham | North Carolina | United States |
| Dallas VAMC | Dallas | Texas | United States |
| Veterans Affairs Medical Center | Houston | Texas | United States |
| Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States |
| Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | United States |
| Hampton VA Medical Center | Hampton | Virginia | United States |
| Hunter Holmes McGuire Medical Center | Richmond | Virginia | United States |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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