Effect of intrapulmonary administration of recombinant human activated protein C on local coagulation and inflammation after bronchial instillation of lipopolysaccharide in humans
- Conditions
- pulmonary inflammation and coagulation1000401810024970
- Registration Number
- NL-OMON31950
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 52
Male subjects between 18 and 35 years of age
No clinically significant findings during physical examination and hematological and biochemical screening
Normal spirometry
Able to communicate well with the investigator and to comply with the requirements of the study
No medication
Written informed consent
No smoking
Known diseases
A history of smoking within the last six months, or regular consumption of greater than three units of alcohol per day
Administration of any investigational drug within 30 days of study initiation
Donation of blood within 60 days, or loss of greater than 400 ml of blood within 12 weeks of study initiation
History of enhanced bleeding tendency
History of heparin-induced thrombocytopenia
History of serious drug-related reactions, including hypersensitivity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the effect of rhAPC on the following LPS-induced responses (by<br /><br>using measurements on cells harvested from BAL-fluid and in BAL-fluid<br /><br>supernatant):<br /><br><br /><br>1. Neutrophil responses<br /><br>2. Response of alveolar macrophages<br /><br>3. Activation of the cytokine network<br /><br>4. Activation of the chemokine network<br /><br>5. Activation of coagulation and fibrinolysis</p><br>
- Secondary Outcome Measures
Name Time Method <p>See primary study parameters.</p><br>