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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Revotar Biopharmaceuticals AG

Criteria

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).