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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
172
75 mg of BIO-11006 administered once per day for 21 days by nebulizer
150 mg of BIO-11006 administered once per day for 21 days by nebulizer
75 mg of BIO-11006 administered twice per day for 21 days by nebulizer
Placebo given once daily for 21 days by nebulizer
125 mg BIO-11006 given twice per day for 21 days by nebulizer
Pulmonary Associates
Glendale, Arizona, United States
Greater Los Angeles Healthcare System
Los Angeles, California, United States
Bay Pines VA Heatlhcare System
Bay Pines, Florida, United States
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, United States
Southeastern Lung Care
Decatur, Georgia, United States
University of Louisville
Louisville, Kentucky, United States
VA Sierra Nevada Health Care System
Reno, Nevada, United States
Duke University Medical Center
Durham, North Carolina, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
Southeastern Research Center, LLC
Winston-Salem, North Carolina, United States
...and 4 more locations
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.
Time frame: Throughout study
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.
Time frame: Day 21 of the study
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