Effectiveness and Safety of BIO-11006 Inhalation Solution to Treat the Overproduction of Mucus and Inflammation in COPD (BREATH-1)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
COPD Chronic Obstructive Pulmonary Disease |
Drug: BIO-11006 Inhalation Solution Drug: Placebo Drug: BIO-11006 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official 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 |
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 172 |
| Study Start Date: | June 2008 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: BIO-11006 Inhalation Solution
75 mg of BIO-11006 administered once per day for 21 days by nebulizer
|
| Experimental: 2 |
Drug: BIO-11006 Inhalation Solution
150 mg of BIO-11006 administered once per day for 21 days by nebulizer
|
| Experimental: 3 |
Drug: BIO-11006 Inhalation Solution
75 mg of BIO-11006 administered twice per day for 21 days by nebulizer
|
| Placebo Comparator: 4 |
Drug: Placebo
Placebo given once daily for 21 days by nebulizer
|
| Experimental: 5 |
Drug: BIO-11006
125 mg BIO-11006 given twice per day for 21 days by nebulizer
|
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.
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Arizona | |
| Pulmonary Associates | |
| Glendale, Arizona, United States, 85306 | |
| United States, California | |
| Greater Los Angeles Healthcare System | |
| Los Angeles, California, United States, 91343 | |
| United States, Florida | |
| Bay Pines VA Heatlhcare System | |
| Bay Pines, Florida, United States, 33744 | |
| Florida Pulmonary Research Institute, LLC | |
| Winter Park, Florida, United States, 32789 | |
| United States, Georgia | |
| Southeastern Lung Care | |
| Decatur, Georgia, United States, 30033 | |
| United States, Kentucky | |
| University of Louisville | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Nevada | |
| VA Sierra Nevada Health Care System | |
| Reno, Nevada, United States, 89502 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27704 | |
| North Carolina Clinical Research | |
| Raleigh, North Carolina, United States, 27607 | |
| Southeastern Research Center, LLC | |
| Winston Salem, North Carolina, United States, 27103 | |
| United States, South Carolina | |
| Spartanburg Medical Research | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Michael E. DeBakey VAMC | |
| Houston, Texas, United States, 77030 | |
| Diagnostics Research Group | |
| San Antonio, Texas, United States, 78229 | |
| Study Director: | Ted C Murphy, Ph.D | BioMarck Pharmaceuticals, Ltd. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Ted Murphy, BioMarck Pharmaceuticals, Ltd |
| ClinicalTrials.gov Identifier: | NCT00648245 History of Changes |
| Other Study ID Numbers: | BIM-CL-003, 5R44HL073591 |
| Study First Received: | March 28, 2008 |
| Last Updated: | February 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by BioMarck Pharmaceuticals, Ltd.:
|
chronic obstructive pulmonary disease COPD Chronic bronchitis |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013