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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44HL073591 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The symptoms associated with COPD include overproduction of mucus and inflammation in the lungs. Overproduction of mucus results in impaired lung function and it encourages bacterial growth and associated COPD exacerbations. Therefore, a treatment that inhibits mucus overproduction or blocks inflammation could benefit COPD patients. The drug under evaluation in this study, BIO-11006 Inhalation Solution, is a new drug that may inhibit overproduction of mucus and may have important anti-inflammatory properties.
COPD encompasses a number of chronic lung disorders that obstruct the airways and may be accompanied by airway hyperactivity. The most common form of COPD is a combination of chronic bronchitis and emphysema. Many of the signs and symptoms associated with chronic bronchitis are a result of airway mucus hypersecretion induced by chronic inflammation of the airways. Clinically, mucus hypersecretion results in impaired gas exchange and compromised mucociliary clearance, encouraging bacterial colonization and associated exacerbations. A treatment that inhibits mucus hypersecretion or blocks inflammation could benefit COPD patients with chronic bronchitis. The drug under evaluation in this study, BIO 11006, is a new therapeutic agent that may inhibit mucus secretion and may have important anti inflammatory properties. In this study, BIO-11006 will be administered to COPD patients with chronic bronchitis, and the effects lung function will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Placebo Comparator |
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| 5 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIO-11006 Inhalation Solution | Drug | 75 mg of BIO-11006 administered once per day for 21 days by nebulizer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of BIO-11006 when administered once or twice daily for 21 days to subjects with COPD by assessing adverse events, physical exams, vital signs, pulmonary function, 12 lead electrocardiogram, clinical blood chemistries, hematology, and urinalysis. | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of BIO-11006 when administered once or twice daily for 21 days to subjects with COPD by assessing the change from baseline in pulmonary function. | Day 21 of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ted C Murphy, Ph.D | BioMarck Pharmaceuticals, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates | Glendale | Arizona | 85306 | United States | ||
| Greater Los Angeles Healthcare System |
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| Label | URL |
|---|---|
| Click here for more information about the sponsor of this study | View source |
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| BIO-11006 Inhalation Solution | Drug | 150 mg of BIO-11006 administered once per day for 21 days by nebulizer |
|
| BIO-11006 Inhalation Solution | Drug | 75 mg of BIO-11006 administered twice per day for 21 days by nebulizer |
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| Placebo | Drug | Placebo given once daily for 21 days by nebulizer |
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| BIO-11006 | Drug | 125 mg BIO-11006 given twice per day for 21 days by nebulizer |
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| Los Angeles |
| California |
| 91343 |
| United States |
| Bay Pines VA Heatlhcare System | Bay Pines | Florida | 33744 | United States |
| Florida Pulmonary Research Institute, LLC | Winter Park | Florida | 32789 | United States |
| Southeastern Lung Care | Decatur | Georgia | 30033 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| VA Sierra Nevada Health Care System | Reno | Nevada | 89502 | United States |
| Duke University Medical Center | Durham | North Carolina | 27704 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Southeastern Research Center, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Michael E. DeBakey VAMC | Houston | Texas | 77030 | United States |
| Diagnostics Research Group | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D029481 | Bronchitis, Chronic |
| 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 |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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