Effectiveness and Safety of BIO-11006 Inhalation Solution to Treat the Overproduction of Mucus and Inflammation in COPD

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioMarck Pharmaceuticals, Ltd.
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Pharmaceutical Solutions

Criteria

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