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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 after 12 weeks of treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 at Visit 3 | week 8 | |
| Trough FVC at Visits 3 and 4 | week 8 and week 12 | |
| FEV1 and FVC 90 min post study drug inhalation at all visits |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Attn: William C. Bailey, M.D. | Birmingham | Alabama | United States | |||
| Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25496316 | Derived | Hohlfeld JM, Furtwaengler A, Konen-Bergmann M, Wallenstein G, Walter B, Bateman ED. Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter-ECG data from four randomised clinical trials. Int J Clin Pract. 2015 Jan;69(1):72-80. doi: 10.1111/ijcp.12596. Epub 2014 Dec 11. |
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| 90 minutes post-medication |
| Use of rescue medication | 12 weeks |
| Patient's Global Evaluation | week 8 and week 12 |
| Physician's Global Evaluation | week 8 and week 12 |
| Health Related Quality of Life assessed by the EQ5D at Visit 2 and 4 | week 8 and week 12 |
| Adverse events | 12 weeks |
| Vital signs | week 8 and week 12 |
| Physical Exam | week 12 |
| 12-lead ECG | week 8 and week 12 |
| 24-hour holter ECG monitoring | week 8 and week 12 |
| Phoenix |
| Arizona |
| United States |
| Olive View UCLA Medical Center | Sylmar | California | United States |
| 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 |
| Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States |
| Boehringer Ingelheim Investigational Site | Houston | Texas | 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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