A Double-blind, Placebo Controlled, Randomized, Cross-over, Phase IIa Study to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia in Healthy Subjects

Revotar Biopharmaceuticals AG1 site in 1 country18 target enrollmentAugust 20, 2009

ConditionsChronic Obstructive Pulmonary Disease (COPD)

InterventionsBimosiamose Placebo

DrugsBimosiamose Placebo

Overview

Phase: Phase 2
Intervention: Bimosiamose
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Revotar Biopharmaceuticals AG
Enrollment: 18
Locations: 1
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 20, 2009

End Date

TBD

Last Updated

16 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Revotar Biopharmaceuticals AG

Eligibility 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).