Effectiveness and Safety of BIO-11006 Inhalation Solution to Treat the Overproduction of Mucus and Inflammation in COPD
- Conditions
- COPDChronic Obstructive Pulmonary Disease
- Interventions
- Registration Number
- NCT00648245
- Lead Sponsor
- BioMarck Pharmaceuticals, Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 172
- Clinically stable male or female outpatients, 45 years of age or older
- Active COPD with chronic bronchitis indicated by: (1) FEV1 = 40% to 70%, (2) FEV1/FVC ≤70%, (3)Chronic productive cough for 3 months in each of 2 successive years, and (4) Sputum (phlegm) production at least several days a week over the past 4 weeks
- Current or previous smoker with a 20-pack year history
- Treatment with oral prednisone during the 6 weeks before enrollment
- Changed inhaled corticosteroid dose or long acting bronchodilator dose during the 6 weeks before enrollment
- Treatment with oxygen (with the exception of night time oxygen) during the 6 weeks before enrollment
- Current asthma as determined by the investigator
- Change in smoking status during the previous 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 BIO-11006 Inhalation Solution - 2 BIO-11006 Inhalation Solution - 1 BIO-11006 Inhalation Solution - 4 Placebo - 5 BIO-11006 -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (14)
VA Sierra Nevada Health Care System
🇺🇸Reno, Nevada, United States
Pulmonary Associates
🇺🇸Glendale, Arizona, United States
Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Diagnostics Research Group
🇺🇸San Antonio, Texas, United States
Southeastern Lung Care
🇺🇸Decatur, Georgia, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Bay Pines VA Heatlhcare System
🇺🇸Bay Pines, Florida, United States
Florida Pulmonary Research Institute, LLC
🇺🇸Winter Park, Florida, United States
Michael E. DeBakey VAMC
🇺🇸Houston, Texas, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
Southeastern Research Center, LLC
🇺🇸Winston Salem, North Carolina, United States