Study to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia

Revotar Biopharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: Placebo

Drug: Bimosiamose

Study type

Interventional

Funder types

Industry

Identifiers

NCT00962481

R014

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and efficacy of repeated inhalative doses of Bimosiamose on ozone induced sputum neutrophilia in healthy subjects.

Enrollment

18 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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).