pulmonary inflammation and coagulation
Conditions
Interventions
Local intrabronchial administration of rhAPC after challenge with
intrabronchial LPS.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effect of rhAPC on the following LPS-induced responses (by using measurements on cells harvested from BAL-fluid and in BAL-fluid supernatant): 1. Neutrophil responses 2. Response of alveolar macrophages 3. Activation of the cytokine network 4. Activation of the chemokine network 5. Activation of coagulation and fibrinolysis | — |
Secondary
| Measure | Time frame |
|---|---|
| See primary study parameters. | — |
Countries
Netherlands
Outcome results
None listed