Lung function Heart function Inflammation Oxidative stress
Conditions
Interventions
4 exposures to ambient air with ultrafine particles derived from road traffic and/or air traffic.
Exposure will take place in a mobile exposure laboratory for 5 hours/day during which the participant
Sponsors
Academic Medical Center Amsterdam in collaboration with the National Institute for Public Health and the Environment (RIVM)
Eligibility
Inclusion criteria
Inclusion criteria: • Healthy subjects between 18 and 35 years of age • No clinically significant findings during physical examination • Baseline FEV1 > than 80% of predicted value • Able to communicate well with the investigator and to comply with the requirements of the study • Written informed consent • No current smoking for at least 1 year and less than 5 pack years of smoking history.
Exclusion criteria
Exclusion criteria: • History of pulmonary or cardiovascular events/diseases • History of hay fever • Use of medications that affect pulmonary or cardiovascular parameters • History of enhanced bleeding tendency • A history of smoking within the last 12 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 • Respiratory tract infection in the last 6 weeks before or during the study • Use of alcohol, tobacco and caffeine-containing drinks in the 24 hours before measurement • History of serious drug-related reactions, including hypersensitivity • Residency or daily work/study activities within 100 meters of a busy road or 300 meters from a freeway. • Residency or daily work/study activities in the area of Schiphol Airport or within distance of 2 kilometers of the Schiphol area. (See Figure 2; map of areas for exclusion)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters are: - Lung function (Flow/Volume) - Oxygen saturation - Heart rate - ECG - SpiroNose measurement - Oxidative stress markers in urine collected shortly before and 24 hours after on site exposure - Molecular markers as measured in peripheral blood | — |
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are exhaled Nitric Oxide (FeNO) for inflammation and blood pressure for the cardiovascular effects | — |
Contacts
Public ContactMarije Lammers
Outcome results
None listed