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The primary objective of this study is to determine the optimum dose of BEA 2180 BR inhalation solut ion delivered by the Respimat ? inhaler once daily for four weeks in patients with COPD.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEA 2180 BR | Drug | |||
| tiotropium | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Trough forced expiratory volume (FEV1) response after four weeks of treatment. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 response after 1 and 2 weeks | after 1 and 2 weeks | |
| Trough FVC response after 1, 2 and 4 weeks | after 1, 2 and 4 weeks | |
| FEV1, FVC AUC0-6h and peak response after 0, 1, 2 and 4 weeks |
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1. Patients with any other significant disease will be excluded. 2. Patients with a history of asthma or allergic rhinitis will be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Lung Health Center | Birmingham | Alabama | United States | |||
| Vapahcs 111P |
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| after 0, 1, 2 and 4 weeks |
| Individual FEV1 and FVC measurements at each time point | 4 weeks |
| Weekly mean pre-dose morning and evening PEFR | 4 weeks |
| Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol] | 4 weeks |
| COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest) | 4 weeks |
| Physician's Global Evaluation | 4 weeks |
| All adverse events | 7 weeks |
| Pulse rate and blood pressure (seated) recorded in conjunction with spirometry up to the three hour pulmonary function test (PFT) | 4 weeks |
| 12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose (Visits 2 and 5) | 4 weeks |
| drug plasma concentrations | 4 or 7 weeks |
| drug urine concentrations | 4 or 7 weeks |
| Palo Alto |
| California |
| United States |
| Boehringer Ingelheim Investigational Site | San Diego | California | United States |
| GLAHS Sepulveda | Sepulveda | California | United States |
| Rehabilitation Clinical Trial Center | Torrance | California | United States |
| Boehringer Ingelheim Investigational Site | Wheat Ridge | Colorado | United States |
| Hospital for Special Care | New Britain | Connecticut | United States |
| Bay Pines VA Medical Center | Bay Pines | Florida | United States |
| Boehringer Ingelheim Investigational Site | Panama City | Florida | United States |
| Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | United States |
| Boehringer Ingelheim Investigational Site | Coeur d'Alene | Idaho | United States |
| LSUHSC - Shreveport | Shreveport | Louisiana | United States |
| VAMC-Reno | Reno | Nevada | United States |
| North Shore Universtiy Hospital | New Hyde Park | New York | United States |
| SVMMC | Toledo | Ohio | United States |
| Boehringer Ingelheim Investigational Site | Medford | Oregon | United States |
| Hershey Medical Center | Hershey | Pennsylvania | United States |
| Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States |
| Frank Sciurba | Pittsburgh | Pennsylvania | United States |
| Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States |
| MUSC | Charleston | South Carolina | United States |
| Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina | United States |
| Boehringer Ingelheim Investigational Site | Harker Heights | Texas | United States |
| MEDVAMC | Houston | Texas | United States |
| McGuire VA | Fredericksburg | Virginia | United States |
| Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States |
| Boehringer Ingelheim Investigational Site | Tacoma | Washington | United States |
| CHU du Sart Tilman (B35) | Angleur | Belgium |
| A.Z. VUB | Brussels | Belgium |
| UZ Antwerpen | Edegem | Belgium |
| AZ Jan Palfijn | Ghent | Belgium |
| UZ Gent | Ghent | Belgium |
| Virga Jesseziekenhuis | Hasselt | Belgium |
| Clinique Reine Astrid | Malmedy | Belgium |
| Heilig Hartziekenhuis | Menen | Belgium |
| Sint-Elisabethziekenhuis | Turnhout | Belgium |
| Ziekenhuisgroep Twente | Almelo | Netherlands |
| Amphia Ziekenhuis | Breda | Netherlands |
| Tjongerschans Ziekenhuis | Heerenveen | Netherlands |
| Atrium Medisch Centrum | Heerlen | Netherlands |
| Ziekenhuisgroep Twente | Hengelo | Netherlands |
| Academisch Ziekenhuis Nijmegen St. Radbout | Nijmegen | Netherlands |
| Gelre Ziekenhuizen | Zutphen | Netherlands |
| 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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