Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2006-000822-30 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotro pium HandiHaler® 18 mcg daily compared to Combivent® MDI CFC Inhalation Aerosol 2 actuations qid in COPD patients currently prescribed Combivent® MDI.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tiotropium | Drug | |||
| ipratropium bromide / albuterol | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 | after 12 weeks of treatment | |
| FEV1 AUC0-6 hours | after 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Peak FEV1 | 12 weeks | |
| Peak FEV1 | after first dose and 6 week | |
| FEV1 AUC0-6 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 205.346.107 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | United States | |||
| 205.346.104 Boehringer Ingelheim Investigational Site |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| after first dose and 6 weeks |
| Trough FEV1 | at 6 weeks |
| Peak FVC at all clinic visits | 12 weeks |
| AUC0-6 hours FVC at all clinic visits | 12 weeks |
| Trough FVC | at 6 and 12 weeks |
| Individual FEV1 measurements | 12 weeks |
| Individual FVC measurements | 12 weeks |
| Use of Albuterol (scheduled and rescue) | 12 weeks |
| Patient Global Evaluation | 12 weeks |
| Physician Global Evaluation | 12 weeks |
| PEFR (Peak expiratory flow rate) measured by the patient at home twice daily | 12 weeks |
| Occurrence of adverse events | 12 weeks |
| Vital Signs | 12 weeks |
| Lakewood |
| California |
| United States |
| 205.346.108 Boehringer Ingelheim Investigational Site | Sepulveda | California | United States |
| 205.346.101 Boehringer Ingelheim Investigational Site | Torrance | California | United States |
| 205.346.106 Boehringer Ingelheim Investigational Site | Wheat Ridge | Colorado | United States |
| 205.346.102 Boehringer Ingelheim Investigational Site | Coeur d'Alene | Idaho | United States |
| 205.346.109 Boehringer Ingelheim Investigational Site | Shreveport | Louisiana | United States |
| 205.346.110 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States |
| 205.346.105 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States |
| 205.346.103 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina | United States |
| 205.346.510 | Bs As | Argentina |
| 205.346.502 | Buenos Aires | Argentina |
| 205.346.503 | Buenos Aires | Argentina |
| 205.346.508 | Buenos Airess | Argentina |
| 205.346.505 | Mendoza | Argentina |
| 205.346.509 | Rosario, Santa Fe | Argentina |
| 205.346.511 | Rosario, Santa Fé | Argentina |
| 205.346.504 Instituto de Patologías Respiratorias | San Miguel de Tucumán | Argentina |
| 205.346.401 Boehringer Ingelheim Investigational Site | Alytus | Lithuania |
| 205.346.404 Boehringer Ingelheim Investigational Site | Kaunas | Lithuania |
| 205.346.405 Boehringer Ingelheim Investigational Site | Kaunas | Lithuania |
| 205.346.411 Boehringer Ingelheim Investigational Site | Klaipėda | Lithuania |
| 205.346.409 Boehringer Ingelheim Investigational Site | Šiauliai | Lithuania |
| 205.346.408 Boehringer Ingelheim Investigational Site | Utena | Lithuania |
| 205.346.402 Boehringer Ingelheim Investigational Site | Vilnius | Lithuania |
| 205.346.406 Boehringer Ingelheim Investigational Site | Vilnius | Lithuania |
| 205.346.407 Boehringer Ingelheim Investigational Site | Vilnius | Lithuania |
| 205.346.302 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia |
| 205.346.305 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia |
| 205.346.301 Boehringer Ingelheim Investigational Site | Košice | Slovakia |
| 205.346.303 Boehringer Ingelheim Investigational Site | Levica | Slovakia |
| 205.346.304 Boehringer Ingelheim Investigational Site | Lučenec | Slovakia |
| 205.346.306 Boehringer Ingelheim Investigational Site | Štúrovo | Slovakia |
| 205.346.204 Boehringer Ingelheim Investigational Site | Aylesbury | United Kingdom |
| 205.346.203 Boehringer Ingelheim Investigational Site | Greenisland | United Kingdom |
| 205.346.201 Boehringer Ingelheim Investigational Site | Nottingham | United Kingdom |
| 205.346.207 Boehringer Ingelheim Investigational Site | Soham | United Kingdom |
| 205.346.209 Boehringer Ingelheim Investigational Site | Swansea | United Kingdom |
| 205.346.206 Boehringer Ingelheim Investigational Site | Westbury on Trym | United Kingdom |
| 205.346.205 Boehringer Ingelheim Investigational Site | Windsor | United Kingdom |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| D009241 | Ipratropium |
| D000420 | Albuterol |
| 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 |
| D001286 | Atropine Derivatives |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
Not provided
Not provided