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The purpose of this study is to demonstrate the superior bronchodilator efficacy of inhaled Combivent® CFC MDI vs. Albuterol HFA MDI in moderate to severe asthma patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combivent® CFC MDI | Drug | |||
| Albuterol HFA MDI | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1 |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 620 South 20th Street, NHB 104 | Birmingham | Alabama | United States | |||
| Cooper Green Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18403223 | Derived | Gelb AF, Karpel J, Wise RA, Cassino C, Johnson P, Conoscenti CS. Bronchodilator efficacy of the fixed combination of ipratropium and albuterol compared to albuterol alone in moderate-to-severe persistent asthma. Pulm Pharmacol Ther. 2008 Aug;21(4):630-6. doi: 10.1016/j.pupt.2008.02.005. Epub 2008 Mar 5. |
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| Birmingham |
| Alabama |
| United States |
| Southern California Clinical Trials | Lakewood | California | United States |
| Boehringer Ingelheim Investigational Site | Palmdale | California | United States |
| Boehringer Ingelheim Investigational Site | Wheat Ridge | Colorado | United States |
| Norwalk Hospital | Norwalk | Connecticut | United States |
| University of Miami School of Medicine | Miami | Florida | United States |
| Boehringer Ingelheim Investigational Site | Panama City | Florida | United States |
| Boehringer Ingelheim Investigational Site | Coeur d'Arlene | Idaho | United States |
| Boehringer Ingelheim Investigational Site | River Forest | Illinois | United States |
| Boehringer Ingelheim Investigational Site | Olathe | Kansas | United States |
| LSU MC-Sheveport | Shreveport | Louisiana | United States |
| Boehringer Ingelheim Investigational Site | Auburn | Maine | United States |
| Johns Hopkins Asthma & Allergy | Baltimore | Maryland | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | United States |
| Boehringer Ingelheim Investigational Site | Berlin | New Jersey | United States |
| Boehringer Ingelheim Investigational Site | Cherry Hill | New Jersey | United States |
| North Shore University Hospital | Manhasset | New York | United States |
| NYU School of Medicine | New York | New York | United States |
| Division of Pulmonary & Critical Care Medicine | Durham | North Carolina | United States |
| Wake Forest University, Center for Human Genomics | Winston-Salem | North Carolina | United States |
| Penn State University, Hershey Medical Center | Hershey | Pennsylvania | United States |
| Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | United States |
| Ben Taul General Hospital | Houston | Texas | United States |
| University of Texas Health Center at Tyler | Tyler | Texas | United States |
| University of Wisconsin Hospital | Madison | Wisconsin | United States |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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