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

Completed · Phase 2 · Has a placebo group

Conditions studied: COPD, Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT00648245

Run by

BioMarck Pharmaceuticals, Ltd.

People needed

172

Starts

2008-06-01

Expected to finish

2010-07-01

Last updated by the study team

2011-02-10

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pulmonary Associates — Glendale, Arizona, United States
• Greater Los Angeles Healthcare System — Los Angeles, California, United States
• Bay Pines VA Heatlhcare System — Bay Pines, Florida, United States
• Florida Pulmonary Research Institute, LLC — Winter Park, Florida, United States
• Southeastern Lung Care — Decatur, Georgia, United States
• University of Louisville — Louisville, Kentucky, United States
• VA Sierra Nevada Health Care System — Reno, Nevada, United States
• Duke University Medical Center — Durham, North Carolina, United States
• North Carolina Clinical Research — Raleigh, North Carolina, United States
• Southeastern Research Center, LLC — Winston-Salem, North Carolina, United States
• Spartanburg Medical Research — Spartanburg, South Carolina, United States
• Baylor College of Medicine — Houston, Texas, United States
• Michael E. DeBakey VAMC — Houston, Texas, United States
• Diagnostics Research Group — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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