Status:
COMPLETED
Effectiveness and Safety of BIO-11006 Inhalation Solution to Treat the Overproduction of Mucus and Inflammation in COPD
Lead Sponsor:
BioMarck Pharmaceuticals, Ltd.
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
COPD
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
45+ years
Phase:
PHASE2
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 associ...
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 em...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00648245
Start Date
June 1 2008
End Date
July 1 2010
Last Update
February 10 2011
Active Locations (14)
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1
Pulmonary Associates
Glendale, Arizona, United States, 85306
2
Greater Los Angeles Healthcare System
Los Angeles, California, United States, 91343
3
Bay Pines VA Heatlhcare System
Bay Pines, Florida, United States, 33744
4
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, United States, 32789