- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03839537
Exposure of Taxi Drivers to Ultrafine Particles and Black Carbon Within Their Vehicles (PUF-TAXI)
Exposure of Taxi Drivers to Ultrafine Particles and Black Carbon Within Their Vehicles: Determinants of In-vehicle Exposure and Short Term Respiratory Impact.
Brief Summary Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis. (Limit: 5000 characters)
Example: The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive hearing loss in both ears due to autoimmune inner ear disease (AIED). This project is part of a research field on the role, not yet fully understood, of atmospheric pollution, especially from road traffic, on respiratory health and allergies, particularly on the development / onset of symptoms and functional disturbances. The ultrafine fraction of particles (UFPs - particles smaller than 100 nm in diameter) is of recent interest because of their ability to induce inflammatory effects, oxidative stress and may contribute to the exacerbation of asthma symptoms in susceptible individuals. UFPs, with their high number concentration and surface area and their small diameter are able not only to convey other contaminants, but also to contribute to a high deposition efficiency, into the alveoli in the lungs. Recently it appeared relevant to be interested in black carbon (BC), components of PM2.5 (particulate matter with a diameter less than 2.5 micrometers), suspected of being responsible for their toxicity. Current epidemiological knowledge of the effects of UFPs and BC are few as compared to those on fine particles. Some professionals, such as police, drivers (taxis, truckers ...), delivery men, postal workers, workers on roads and highways, etc. are heavily exposed, during their working hours, to air pollution due to road traffic. These occupational groups appear to be at greater risk for developing respiratory, cardiovascular and neurological diseases than the general population. Occupational exposure to diesel exhaust has been associated with an increased risk of lung cancer mortality and chronic obstructive pulmonary disease. Occupational exposure to UFPs and BC has rarely been measured due to a lack of suitable devices. Therefore, this project's originality consists in measuring UFPs and BC by using portable devices developed in the recent years. The use of these devices, linking their recordings with ventilatory measures and repeating them, offers the rare opportunity to study the short-term respiratory health impact of this occupational exposure, which has never been described in the literature. Our research aims to: 1/ quantify the occupational exposure of taxi drivers to UFP, BC, oxides of carbon (CO, CO2) and to nitrogen dioxide (NO2), 2/ identify spatio-temporal variability and patterns of exposure related to occupational tasks, 3/ study the impact of this occupational exposure to UFP and BC on ventilation performances and respiratory symptoms.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Paris
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Paris, Paris, France, 75006
- Paris Descartes University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age > 18 years
- Full time licensed taxi driver
- Subjects with more than 6 months of job tenure (as a taxi driver)
- Subjects affiliated to a social security scheme
- Subjects must have signed an informed consent and are willing to participate in the study
Exclusion Criteria:
- Subjects having difficulty to understand the French language
- Subjects with less than 6 months of job tenure (as a taxi driver)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean number of ultrafine fraction of particles (UFP)
Time Frame: 6 months
|
per cm3 of air [from 1000 to 1000000 particles (pt)/cm3] - 8-11 h recording on 1 working day for each subject - repeated measurement in cold and warm seasons (6 months apart)
|
6 months
|
|
Mean concentration of black carbon (BC)
Time Frame: 6 months
|
measurement of BC exposure concentrations per cubic meter (ng/m3) by the microAeth AE51 - 8-11 h recording on 1 working day for each subject - repeated measurement in cold and warm seasons (6 months apart)
|
6 months
|
|
Difference between the values of the forced vital capacity (FVC) measured before and after work shift
Time Frame: 36 months
|
measurement of FVC in liters by a portable spirometer before and after the work shift according to procedures described by The European Respiratory Society and the American Thoracic Society (2005) - 2 measurements per subject - before and after the work shift - 1 working day Repeated measurement in cold and warm seasons (6 months apart) Overall period: 2 working days (one in each season) - 36 months
|
36 months
|
|
Difference between the values of the forced expiratory volume in one second (FEV1) measured before and after work shift
Time Frame: 36 months
|
measurement of FEV1 in liters by a portable spirometer before and after the work shift according to procedures described by The European Respiratory Society and the American Thoracic Society (2005) -2 measurements per subject - before and after the work shift - 1 working day Repeated measurement in cold and warm seasons (6 months apart) Overall period: 2 working days (one in each season) - 36 months
|
36 months
|
|
Difference between the values of the forced expiratory flow between 25 and 75 % of FVC (FEF25-75) measured before and after work shift
Time Frame: 36 months
|
measurement of FEF25-75 in liters by a portable spirometer before and after the work shift according to procedures described by The European Respiratory Society and the American Thoracic Society (2005).
-2 measurements per subject - before and after the work shift - 1 working day Repeated measurement in cold and warm seasons (6 months apart) Overall period: 2 working days (one in each season) - 36 months
|
36 months
|
|
Difference between the rates of the peak expiratory flow (PEF) measured before and after work shift
Time Frame: 36 months
|
measurement of PEF in liter per second (L.s-1) by a portable spirometer before and after the work shift according to procedures described by The European Respiratory Society and the American Thoracic Society (2005)-2 measurements per subject - before and after the work shift - 1 working day Repeated measurement in cold and warm seasons (6 months apart) Overall period: 2 working days (one in each season) - 36 months
|
36 months
|
|
Acute respiratory symptoms through self-administered questionnaire
Time Frame: 36 months
|
by means of a self-completion questionnaire, participants report their acute respiratory symptoms felt during the measurement day - Reported before and after the work shift per subject - In cold and warm seasons (6 months apart)- Overall period: reported during 2 working days (one in each season) - 36 months
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Characteristics of vehicles recorded by a self-administered questionnaire
Time Frame: 36 months
|
fuel, age and type of the vehicle, air conditioning, air cabin filter reported by a self-administered questionnaire - after the work shift per subject - In cold and warm seasons (6 months apart) Overall period: reported during 2 working days (one in each season) - 36 months
|
36 months
|
|
Characteristics of the trips recorded by a self-administered questionnaire
Time Frame: 36 months
|
speed, opened/closed windows, smoking, breaks, etc. reported by a self-administered questionnaire - after the work shift per subject - In cold and warm seasons (6 months apart) Overall period: reported during 2 working days (one in each season) - 36 months
|
36 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lynda BENSEFA-COLAS, MD, PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
General Publications
- Hachem M, Saleh N, Bensefa-Colas L, Momas I. Determinants of ultrafine particles, black carbon, nitrogen dioxide, and carbon monoxide concentrations inside vehicles in the Paris area: PUF-TAXI study. Indoor Air. 2021 May;31(3):848-859. doi: 10.1111/ina.12779. Epub 2020 Dec 22.
- Hachem M, Loizeau M, Saleh N, Momas I, Bensefa-Colas L. Short-term association of in-vehicle ultrafine particles and black carbon concentrations with respiratory health in Parisian taxi drivers. Environ Int. 2021 Feb;147:106346. doi: 10.1016/j.envint.2020.106346. Epub 2020 Dec 31.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K180303J
- 2018-A00811-54 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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