NCT03839537

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2020

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

January 7, 2019

Last Update Submit

March 6, 2026

Conditions

Keywords

Ultrafine particlesblack carbontaxi driversrespiratory function testoccupational exposure

Outcome Measures

Primary Outcomes (7)

  • Mean number of ultrafine fraction of particles (UFP)

    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)

    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

    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

    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

    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

    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

    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 Outcomes (2)

  • Characteristics of vehicles recorded by a self-administered questionnaire

    36 months

  • Characteristics of the trips recorded by a self-administered questionnaire

    36 months

Interventions

* 2 measurements per subject - before and after the work shift - in warm and cold seasons * Subject will inhale and exhale in the device

Also known as: Spirobank II

\- Performed by a physician during the inclusion clinical examination

* 2 measurements per subject (in warm season and in cold season) * Devices placed inside taxi vehicles on the passenger seat in a sampling bag

Also known as: Exposure measurement of UFP, BC, NO2, CO, CO2

* 2 measurements per subject - before and after the work shift - in warm and cold seasons * Subject will exhale in the device

Also known as: Smokerlyzer- Micro
Skin allergy testDIAGNOSTIC_TEST

\- Performed by a physician during the inclusion clinical examination

Also known as: Prick test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects having difficulty to understand the French language
  • Subjects with less than 6 months of job tenure (as a taxi driver)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paris Descartes University

Paris, Paris, 75006, France

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Interventions

Skin TestsPatch TestsSpirometryFractional Exhaled Nitric Oxide Testing

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesRespiratory Function TestsDiagnostic Techniques, Respiratory SystemBreath Tests

Study Officials

  • Lynda BENSEFA-COLAS, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2019

First Posted

February 15, 2019

Study Start

February 1, 2019

Primary Completion

June 11, 2020

Study Completion

June 11, 2020

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations