Status:
COMPLETED
Study to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia
Lead Sponsor:
Revotar Biopharmaceuticals AG
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00962481
Last Update
January 6 2010
Active Locations (1)
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1
Pneumologisches Forschungsinstitut GmbH am Krankenhaus Großhansdorf
Großhansdorf, Germany