Health effects due to inhalation of ultrafine particles in healthy volunteers. Multiple short-term exposures to UFP near Schiphol Airport. A cross-over study

Completed

• Conditions: airway narrowing; Bronchial obstruction; heart function; 10064477; 10007521; 10006436

• Registration Number: NL-OMON46447
• Lead Sponsor: RIVM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Exhaled Nitric Oxide (FeNO)<br /><br>- Blood pressure</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Lung function (Flow/Volume)<br /><br>- Oxygen saturation<br /><br>- Heart rate<br /><br>- ECG<br /><br>- SpiroNose measurement<br /><br>- Low molecular metabolites in urine</p><br>