Study to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia
Phase 2
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: Placebo
- Registration Number
- NCT00962481
- Lead Sponsor
- Revotar Biopharmaceuticals AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Bimosiamose Bimosiamose - Placebo Placebo -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pneumologisches Forschungsinstitut GmbH am Krankenhaus Großhansdorf
🇩🇪Großhansdorf, Germany