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…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Cardiac arrhythmias
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Exhaled Nitric Oxide (FeNO)
- Blood pressure
Secondary outcome
- Lung function (Flow/Volume)
- Oxygen saturation
- Heart rate
- ECG
- SpiroNose measurement
- Low molecular metabolites in urine
Background summary
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.
Study 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.
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. In case
of low exposures during the first 4 visits, the RIVM can decide to schedule
another fifth or sixth exposure (after consent of the subject).
Study burden and risks
Burden:
1 screeningsvisit (1,5h): medical background, blood pressure, heart rate and
saturation measurement, ECG, long function and exhaled breath measurement.
4 study days (10h/day) with at least 2 weeks in between
Possibly 5 or 6 study days, in case of low exposures in the first 4 visits (as
judged by the RIVM) and after consent of the subject
Study day:
- pré exposure: urine sample, blood pressure, heart rate and saturation
measurement, ECG, long function and exhaled breath measurement.
- exposure: 5 hours in MAPCEL nearby Schiphol Airport. Subjects cycle 1x20
minutes/hour on a hometrainer
- post exposure: blood pressure, heart rate and saturation measurement, ECG,
long function and exhaled breath measurement.
- day after exposure: urine sample
No invasive measurements
Risks: No expected health risks
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
* Healthy subjects between 18 and 35 years of age
* 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
* History of pulmonary or cardiovascular events/diseases
* History of hay fever/pulmonary disease
* 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
* Current pregnancy
* 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 kilometres of the Schiphol area.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63438.018.17 |
| Other | NTR 28094 |
| OMON | NL-OMON27988 |