Invloed van ultrafijn stof op de gezondheid van gezonde vrijwilligers:
"Klinische studie ultrafijn stof rondom Schiphol"

Rationale: Air pollution in general is known to cause pulmonary and cardiovascular health effects. Ultrafine particles (UFP) (< 0.1 µm) comprise a large part of particulate material from air pollution. The concentration of ultrafine particles near airports is increased. Concern is rising for the health effects of people living in the vicinity of Schiphol Airport.

Objective:

We hypothesize that the toxic potency of UFP from air traffic is comparable to road traffic after inhalation by healthy humans. Therefore, we aim to:

• Identify acute effects of short-term inhalation of ultrafine particles right next to Amsterdam Schiphol Airport (dominated by aviation exhaust but also with contributions from road traffic exhaust) by assessing pulmonary, cardiovascular, and oxidative stress parameters

• To relate the effects with total UFP (inhaled as well as estimated dose) as well as to UFP apportioned to aviation and road traffic.


Study design: This will be a single center, randomized, double blind, cross-over study in healthy volunteers.


Study population: 20 healthy human volunteers, 18 – 35 years’ old


Intervention: Volunteers will be exposed for four separate days to ultrafine particles present in local air drawn into a mobile exposure laboratory (MAPCEL) of the RIVM. Exposure will take place in the proximity of air traffic activity, with, depending on the wind direction also an impact of near road traffic. The volunteers will be blinded for the type of exposure and they will do intermittent exercise on a bicycle ergometer during the exposure period, which will be 5 hours per exposure day. There will be a minimum of 2 weeks between exposure days and each volunteer will be exposed for at least 4 times.


Main study parameters/endpoints: The primary endpoints are changes in exhaled Nitric Oxide (FeNO) for inflammation and Blood Pressure for the cardiovascular effects. Secondary endpoints comprise additional lung function tests, heart rate, ECG, inflammation and oxidative stress parameters in peripheral blood, and oxidative stress parameters in urine.


Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden associated with this study includes a screening visit, during which an intake interview, a physical examination, and lung function will be done. At an exposure day, participants will come to the AMC for baseline measurements of lung function, cardiovascular parameters, urine sample and blood draw (15 mL). Then they will be transported to the exposure location, be exposed for 5 hours in which they perform intermittent, moderate exercise. After the exposure period, they will be transported back to the AMC for repeated measurements. The morning after the study day, a second urine sample will be collected by the participant and sent to the AMC. Each volunteer will receive 4 exposure days with at least 2 weeks in between. We believe the burden of this study is mainly an investment of time.


Relevance: This study will report on the health effects of inhalation of total and air traffic derived ultrafine particles in comparison with road traffic derived particles, and filtered air. Thereby, answering several questions considering the risks of air traffic exhaust in relation to road traffic exhaust. As such, we consider the balance between risks and discomfort for the study subjects (low) and the possible benefit for society in the future acceptable.

We hypothesize that the toxic potency of UFP from air traffic is comparable to road traffic after inhalation by healthy humans. Therefore, we aim to:

• Identify acute effects of short-term inhalation of ultrafine particles right next to Amsterdam Schiphol Airport (dominated by aviation exhaust but also with contributions from road traffic exhaust) by assessing pulmonary, cardiovascular, and oxidative stress parameters

• To relate the effects with total UFP (inhaled as well as estimated dose) as well as to UFP apportioned to aviation and road traffic.

Screening visit

Study days:

- Baseline measurements T = 0h

- Exposure for 5 hours

- Post-exposure measurements T = 8h

- Post exposure urine sample T = 2h4

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 participants will perform moderate exercise.