Trial Information

Summary: A phase IIA, dose escalating study to evaluate the safety, tolerability and efficacy of BIO-11006, a nebulized investigational inhalation solution, versus placebo in subjects with COPD suffering from chronic bronchitis. BIO-11006 Inhalation Solution is an investigational therapeutic agent that is being tested for its ability to inhibit mucus secretion and to reduce inflammation.

This research trial will be conducted over the course of 2 months and will include 11 clinic visits. Study procedures include clinical lab work, physical examinations, EKGs, pulmonary function tests, lung volume testing, 6 minute walk tests and questionnaires.

Patient Inclusion Criteria
Eligible candidates must have a clinical diagnosis of COPD with chronic bronchitis. Patients should be 45 years of age or older and can be male or female. Current or former smokers with at least a 20 pack year history of smoking.

Patient Exclusion Criteria
Use of oxygen 6 weeks preceding the study and throughout. Change in smoking status in the previous 6 months. History of cancer other than basal cell carcinoma. Pregnancy. Any clinically significant history of heart, liver or lung disease other than COPD. Participants will also be deemed ineligible with unstable diabetes or hypertension.

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Trial listings updated: August 26, 2008 at 2:45:39 PM