Study to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Able to produce sputum with normal sputum neutrophil levels at screening (< 65% of non-epithelial cells).
Ozone responsive, defined as ≥ 20% relative increase in sputum neutrophils cell count after 3 h ozone challenge.
At screening FEV1 at least 80% of predicted.
Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports of a recent tobacco use and/or who has a urine cotinine ≥ 500 ng/mL.
Significant illness within two weeks prior to dosing (e.g., infection).
Recent (within the last three years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).