carbon nanoparticles - air pollution - lung inflammation - coagulation koolstof nanopartikels - luchtvervuiling - luchtwegontsteking - stolling
Conditions
Interventions
Volunteers will receive a bronchial instillation of a carbon nanoparticle suspension.
Controls will receive a bronchial instillation with saline.
Sponsors
Academic Medical Center (AMC) Amsterdam. Department of Pulmonology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy, male subjects between 18 and 45 years of age; 2. No clinically significant findings during physical examination and haematological and biochemical screening; 3. Baseline FEV1 > than 80% of predicted value; 4. Able to communicate well with the investigator and to comply with the requirements of the study; 5. Written informed consent; 6. No current smoking for at least 1 year and less than 5 pack years of smoking history.
Exclusion criteria
Exclusion criteria: 1. History of pulmonary or any other relevant disease; 2. History of enhanced bleeding tendency; 3. A history of smoking within the last 12 months, or regular consumption of greater than three units of alcohol per day; 4. Administration of any investigational drug within 30 days of study initiation; 5. Donation of blood within 60 days, or loss of greater than 400 ml of blood within 12 weeks of study initiation; 6. History of serious drug-related reactions, including hypersensitivity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Total leukocyte count and differentials in bronchoalveolar lavage fluid; 2. Activation of coagulation and fibrinolysis in bronchoalveolar lavage fluid. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Amino acid pattern in exhaled breath condensate; 2. Metabolomic fingerprint as obtained by Liquid chromatography-mass spectrometry (LC-MS); 3. Safety outcome parameters (Physical complaints of the volunteer, Blood pressure, Heart rate, Temperature, Lungfunction, Oxygen saturation, (Serious) Adverse Events. | — |
Contacts
Public ContactM. Berger
Outcome results
None listed