<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03839537</url>
  </required_header>
  <id_info>
    <org_study_id>K180303J</org_study_id>
    <secondary_id>2018-A00811-54</secondary_id>
    <nct_id>NCT03839537</nct_id>
  </id_info>
  <brief_title>Exposure of Taxi Drivers to Ultrafine Particles and Black Carbon Within Their Vehicles</brief_title>
  <acronym>PUF-TAXI</acronym>
  <official_title>Exposure of Taxi Drivers to Ultrafine Particles and Black Carbon Within Their Vehicles: Determinants of In-vehicle Exposure and Short Term Respiratory Impact.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Paris 5 - Rene Descartes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre national de la recherche scientifique - Lebanon (CNRS-L)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>French Environment and Energy Management Agency</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Brief Summary Short description of the protocol intended for the lay public. Include a brief&#xD;
      statement of the study hypothesis. (Limit: 5000 characters)&#xD;
&#xD;
      Example: The purpose of this study is to determine whether prednisone, methotrexate, and&#xD;
      cyclophosphamide are effective in the treatment of rapidly progressive hearing loss in both&#xD;
      ears due to autoimmune inner ear disease (AIED). This project is part of a research field on&#xD;
      the role, not yet fully understood, of atmospheric pollution, especially from road traffic,&#xD;
      on respiratory health and allergies, particularly on the development / onset of symptoms and&#xD;
      functional disturbances. The ultrafine fraction of particles (UFPs - particles smaller than&#xD;
      100 nm in diameter) is of recent interest because of their ability to induce inflammatory&#xD;
      effects, oxidative stress and may contribute to the exacerbation of asthma symptoms in&#xD;
      susceptible individuals. UFPs, with their high number concentration and surface area and&#xD;
      their small diameter are able not only to convey other contaminants, but also to contribute&#xD;
      to a high deposition efficiency, into the alveoli in the lungs. Recently it appeared relevant&#xD;
      to be interested in black carbon (BC), components of PM2.5 (particulate matter with a&#xD;
      diameter less than 2.5 micrometers), suspected of being responsible for their toxicity.&#xD;
      Current epidemiological knowledge of the effects of UFPs and BC are few as compared to those&#xD;
      on fine particles. Some professionals, such as police, drivers (taxis, truckers ...),&#xD;
      delivery men, postal workers, workers on roads and highways, etc. are heavily exposed, during&#xD;
      their working hours, to air pollution due to road traffic. These occupational groups appear&#xD;
      to be at greater risk for developing respiratory, cardiovascular and neurological diseases&#xD;
      than the general population. Occupational exposure to diesel exhaust has been associated with&#xD;
      an increased risk of lung cancer mortality and chronic obstructive pulmonary disease.&#xD;
      Occupational exposure to UFPs and BC has rarely been measured due to a lack of suitable&#xD;
      devices. Therefore, this project's originality consists in measuring UFPs and BC by using&#xD;
      portable devices developed in the recent years. The use of these devices, linking their&#xD;
      recordings with ventilatory measures and repeating them, offers the rare opportunity to study&#xD;
      the short-term respiratory health impact of this occupational exposure, which has never been&#xD;
      described in the literature. Our research aims to: 1/ quantify the occupational exposure of&#xD;
      taxi drivers to UFP, BC, oxides of carbon (CO, CO2) and to nitrogen dioxide (NO2), 2/&#xD;
      identify spatio-temporal variability and patterns of exposure related to occupational tasks,&#xD;
      3/ study the impact of this occupational exposure to UFP and BC on ventilation performances&#xD;
      and respiratory symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is based on a random sampling of 100 taxi drivers, working full-time day shift, in&#xD;
      Paris, members of three Trade Unions. It will be conducted over a period of two years in warm&#xD;
      and cold season. The research will begin with an inclusion clinical examination. It consists&#xD;
      on determining the overall health status of the participants by administering a standardized&#xD;
      questionnaire and performing spirometry test, prick test and FENO measurement. The exposure&#xD;
      assessment will be based on continuous measurement of UFP, BC, carbon monoxide (CO) and NO2,&#xD;
      by portable devices during a working day (± 11 hours). On the same day, two spirometry tests&#xD;
      and two measurements of exhaled carbon monoxide will be performed at the beginning and at the&#xD;
      end of the shift, using handheld devices. Multivariate analysis will provide spatio-temporal&#xD;
      distributions of individual exposures and their determinants. Generalized Estimating&#xD;
      Equations (GEE) multivariate models will be used to determine the relation between exposure&#xD;
      (UFP, BC) and respiratory symptoms, ventilation performances, adjusting for potential&#xD;
      confounding/modifying factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">June 11, 2020</completion_date>
  <primary_completion_date type="Actual">June 11, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean number of ultrafine fraction of particles (UFP)</measure>
    <time_frame>6 months</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean concentration of black carbon (BC)</measure>
    <time_frame>6 months</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference between the values of the forced vital capacity (FVC) measured before and after work shift</measure>
    <time_frame>36 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference between the values of the forced expiratory volume in one second (FEV1) measured before and after work shift</measure>
    <time_frame>36 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference between the values of the forced expiratory flow between 25 and 75 % of FVC (FEF25-75) measured before and after work shift</measure>
    <time_frame>36 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference between the rates of the peak expiratory flow (PEF) measured before and after work shift</measure>
    <time_frame>36 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute respiratory symptoms through self-administered questionnaire</measure>
    <time_frame>36 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characteristics of vehicles recorded by a self-administered questionnaire</measure>
    <time_frame>36 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of the trips recorded by a self-administered questionnaire</measure>
    <time_frame>36 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <enrollment type="Actual">56</enrollment>
  <condition>Pulmonary Ventilation</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exposure measurement</intervention_name>
    <description>2 measurements per subject (in warm season and in cold season)&#xD;
Devices placed inside taxi vehicles on the passenger seat in a sampling bag</description>
    <other_name>Exposure measurement of UFP, BC, NO2, CO, CO2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spirometry test</intervention_name>
    <description>2 measurements per subject - before and after the work shift - in warm and cold seasons&#xD;
Subject will inhale and exhale in the device</description>
    <other_name>Spirobank II</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Exhaled carbon monoxide test</intervention_name>
    <description>2 measurements per subject - before and after the work shift - in warm and cold seasons&#xD;
Subject will exhale in the device</description>
    <other_name>Smokerlyzer- Micro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Skin allergy test</intervention_name>
    <description>- Performed by a physician during the inclusion clinical examination</description>
    <other_name>Prick test</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Spirometry test</intervention_name>
    <description>- Performed by a physician during the inclusion clinical examination</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Fractional Exhaled Nitric Oxide Testing</intervention_name>
    <description>- Performed by a physician during the inclusion clinical examination</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Full time licensed taxi driver&#xD;
&#xD;
          -  Subjects with more than 6 months of job tenure (as a taxi driver)&#xD;
&#xD;
          -  Subjects affiliated to a social security scheme&#xD;
&#xD;
          -  Subjects must have signed an informed consent and are willing to participate in the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects having difficulty to understand the French language&#xD;
&#xD;
          -  Subjects with less than 6 months of job tenure (as a taxi driver)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lynda BENSEFA-COLAS, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Paris Descartes University</name>
      <address>
        <city>Paris</city>
        <zip>75006</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>July 31, 2021</last_update_submitted>
  <last_update_submitted_qc>July 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ultrafine particles</keyword>
  <keyword>black carbon</keyword>
  <keyword>taxi drivers</keyword>
  <keyword>respiratory function test</keyword>
  <keyword>occupational exposure</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nitric Oxide</mesh_term>
    <mesh_term>Carbon Monoxide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03839537
org study id: K180303J
secondary id: 2018-A00811-54
nct id: NCT03839537
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
The study is based on a random sampling of 100 taxi drivers, working full-time day shift, in
      Paris, members of three Trade Unions. It will be conducted over a period of two years in warm
      and cold season. The research will begin with an inclusion clinical examination. It consists
      on determining the overall health status of the participants by administering a standardized
      questionnaire and performing spirometry test, prick test and FENO measurement. The exposure
      assessment will be based on continuous measurement of UFP, BC, carbon monoxide (CO) and NO2,
      by portable devices during a working day (± 11 hours). On the same day, two spirometry tests
      and two measurements of exhaled carbon monoxide will be performed at the beginning and at the
      end of the shift, using handheld devices. Multivariate analysis will provide spatio-temporal
      distributions of individual exposures and their determinants. Generalized Estimating
      Equations (GEE) multivariate models will be used to determine the relation between exposure
      (UFP, BC) and respiratory symptoms, ventilation performances, adjusting for potential
      confounding/modifying factors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Mean number of ultrafine fraction of particles (UFP)
time frame: 6 months
description: 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)
measure: Mean concentration of black carbon (BC)
time frame: 6 months
description: 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)
measure: Difference between the values of the forced vital capacity (FVC) measured before and after work shift
time frame: 36 months
description: 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
measure: Difference between the values of the forced expiratory volume in one second (FEV1) measured before and after work shift
time frame: 36 months
description: 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
measure: 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
description: 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
measure: Difference between the rates of the peak expiratory flow (PEF) measured before and after work shift
time frame: 36 months
description: 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
measure: Acute respiratory symptoms through self-administered questionnaire
time frame: 36 months
description: 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
measure: Characteristics of vehicles recorded by a self-administered questionnaire
time frame: 36 months
description: 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
measure: Characteristics of the trips recorded by a self-administered questionnaire
time frame: 36 months
description: 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
intervention type: Other
intervention name: Exposure measurement
description: 2 measurements per subject (in warm season and in cold season)
Devices placed inside taxi vehicles on the passenger seat in a sampling bag
other name: Exposure measurement of UFP, BC, NO2, CO, CO2
intervention type: Other
intervention name: Spirometry test
description: 2 measurements per subject - before and after the work shift - in warm and cold seasons
Subject will inhale and exhale in the device
other name: Spirobank II
intervention type: Diagnostic Test
intervention name: Exhaled carbon monoxide test
description: 2 measurements per subject - before and after the work shift - in warm and cold seasons
Subject will exhale in the device
other name: Smokerlyzer- Micro
intervention type: Diagnostic Test
intervention name: Skin allergy test
description: - Performed by a physician during the inclusion clinical examination
other name: Prick test
intervention type: Diagnostic Test
intervention name: Spirometry test
description: - Performed by a physician during the inclusion clinical examination
intervention type: Diagnostic Test
intervention name: Fractional Exhaled Nitric Oxide Testing
description: - Performed by a physician during the inclusion clinical examination
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lynda BENSEFA-COLAS, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Nitric Oxide
mesh term: Carbon Monoxide
sharing ipd: Undecided