Pulmonary VentilationPUF-TAXINCT03839537
Exposure of Taxi Drivers to Ultrafine Particles and Black Carbon Within Their Vehicles
A study testing Exposure measurement, Spirometry test and Exhaled carbon monoxide test in people with Pulmonary Ventilation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Ventilation
- What is being tested?
- Exposure measurement, Spirometry test and Exhaled carbon monoxide test
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2019to 11 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects having difficulty to understand the French language
- Subjects with less than 6 months of job tenure (as a taxi driver)
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed description
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.
- Conditions
- Pulmonary Ventilation
- Being tested
- Exposure measurement, Spirometry test, Exhaled carbon monoxide test, Skin allergy test, Fractional Exhaled Nitric Oxide Testing
- Keywords
- Ultrafine particles, black carbon, taxi drivers, respiratory function test, occupational exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure measurementOther
Also called Exposure measurement of UFP, BC, NO2, CO, CO2
- 2 measurements per subject (in warm season and in cold season)
- Devices placed inside taxi vehicles on the passenger seat in a sampling bag
Spirometry testOther
Also called Spirobank II
- 2 measurements per subject - before and after the work shift - in warm and cold seasons
- Subject will inhale and exhale in the device
Exhaled carbon monoxide testDiagnostic test
Also called Smokerlyzer- Micro
- 2 measurements per subject - before and after the work shift - in warm and cold seasons
- Subject will exhale in the device
Skin allergy testDiagnostic test
Also called Prick test
- Performed by a physician during the inclusion clinical examination
Spirometry testDiagnostic test
- Performed by a physician during the inclusion clinical examination
Fractional Exhaled Nitric Oxide TestingDiagnostic test
- Performed by a physician during the inclusion clinical examination
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 36 months
Secondary outcomes (2)
Characteristics of vehicles recorded by a self-administered questionnaire
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
Measured: 36 months
Characteristics of the trips recorded by a self-administered questionnaire
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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Feb 2019
- Primary completion11 Jun 2020
- Study completion11 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary VentilationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- University of Paris 5 - Rene Descartes, Centre national de la recherche scientifique - Lebanon (CNRS-L), French Environment and Energy Management Agency, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Lynda BENSEFA-COLAS, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839537
- Sponsor's protocol ID
- K180303J
- Other IDs
- 2018-A00811-54
- Acronym
- PUF-TAXI
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2019
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33388565Hachem 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.
PubMed 33350528
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03839537
- Acronym / sponsor ID
- PUF-TAXI / K180303J
- Conditions
- Pulmonary Ventilation
- Keywords
- Ultrafine particles, black carbon, taxi drivers, respiratory function test, occupational exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- University of Paris 5 - Rene Descartes, Centre national de la recherche scientifique - Lebanon (CNRS-L), French Environment and Energy Management Agency, URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 11 Jun 2020 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects having difficulty to understand the French language
- Subjects with less than 6 months of job tenure (as a taxi driver)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure measurementAlso: Exposure measurement of UFP, BC, NO2, CO, CO2* 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 | – |
| Spirometry testAlso: Spirobank II* 2 measurements per subject - before and after the work shift - in warm and cold seasons * Subject will inhale and exhale in the device | Other | – |
| Exhaled carbon monoxide testAlso: Smokerlyzer- Micro* 2 measurements per subject - before and after the work shift - in warm and cold seasons * Subject will exhale in the device | Diagnostic test | – |
| Skin allergy testAlso: Prick test- Performed by a physician during the inclusion clinical examination | Diagnostic test | – |
| Spirometry test- Performed by a physician during the inclusion clinical examination | Diagnostic test | – |
| Fractional Exhaled Nitric Oxide Testing- Performed by a physician during the inclusion clinical examination | Diagnostic test | – |
Primary outcome
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)
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)
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
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
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
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
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
2 secondary outcomes
Characteristics of vehicles recorded by a self-administered questionnaire
Time frame: 36 months
Characteristics of the trips recorded by a self-administered questionnaire
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Results publication: PubMed 33388565Hachem 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.
- Results publication: PubMed 33350528Hachem 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.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Ventilation
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynda BENSEFA-COLAS, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure measurement, Spirometry test and Exhaled carbon monoxide test in people with Pulmonary Ventilation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of ultrafine fraction of particles (UFP) (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03839537, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.