Chronic Obstructive Pulmonary Disease Clinical Trial
— BREATH-1Official title:
A Phase 2a, Double Blind, Placebo Controlled, Multicenter, Dose Escalation Study to Evaluate the Safety and Efficacy of BIO 11006 Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
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.
Status | Completed |
Enrollment | 172 |
Est. completion date | July 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Bay Pines VA Heatlhcare System | Bay Pines | Florida |
United States | Southeastern Lung Care | Decatur | Georgia |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Pulmonary Associates | Glendale | Arizona |
United States | Baylor College of Medicine | Houston | Texas |
United States | Michael E. DeBakey VAMC | Houston | Texas |
United States | Greater Los Angeles Healthcare System | Los Angeles | California |
United States | University of Louisville | Louisville | Kentucky |
United States | North Carolina Clinical Research | Raleigh | North Carolina |
United States | VA Sierra Nevada Health Care System | Reno | Nevada |
United States | Diagnostics Research Group | San Antonio | Texas |
United States | Spartanburg Medical Research | Spartanburg | South Carolina |
United States | Southeastern Research Center, LLC | Winston Salem | North Carolina |
United States | Florida Pulmonary Research Institute, LLC | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
BioMarck Pharmaceuticals, Ltd. | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | 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 | No |
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