NCT03234790

Brief Summary

Strong scientific understanding of how emissions from diesel engines impact the lungs could improve policies and regulations protecting workers exposed to diesel exhaust. Accordingly, we are recruiting healthy volunteers who are non-smokers to participate in our study. Volunteers sit in a room for four hours and breathe either clean filtered air or air that contains pollution at various concentrations similar to occupational settings such as bus and ferry terminals where diesel engines are used. A respirologist assesses the volunteer's lung health and clinical samples are taken. We are equipped with advanced molecular biology tools to measure different molecules and compare samples from our volunteer subjects following exposure to clean air or diesel exhaust. Our research aim is to find a simple, clinically relevant strategy that can be used to measure the impact of diesel exhaust on workers' lung health. This knowledge will empower regulators, companies, and ultimately workers to better manage their health risks. Our research aims to provide specific data to help regulators to make informed decisions about the risks of diesel exhaust exposure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

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

July 25, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 27, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2021

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

3.8 years

First QC Date

July 25, 2017

Last Update Submit

October 29, 2021

Conditions

Experimental

Keywords

Diesel ExhaustAir PollutionAirway ResponsivenessProteomicsUrine PAH Metabolites

Outcome Measures

Primary Outcomes (1)

  • Serum proteome in response to DE exposure

    Serum from each experimental condition will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS) to observe any changes between the baseline and listed time points

    4 hours & 24 hours

Secondary Outcomes (3)

  • Urine proteins in response to DE exposure

    4 hours & 24 hours

  • Polycyclic Aromatic Hydrocarbons (PAH) metabolites in response to DE exposure

    4 hours & 24 hours

  • Sleep quality

    baseline versus 24 hours post-exposure

Study Arms (2)

Filtered Air Exposure

ACTIVE COMPARATOR

Exposure for 4 hours to filtered air

Other: Filtered Air Exposure

Diesel Exhaust Exposure

EXPERIMENTAL

Volunteers exposed to different concentrations of diesel exhaust

Other: Diesel Exhaust Exposure

Interventions

Filtered Air ExposureOTHER

Exposure to Filtered air

Filtered Air Exposure
Diesel Exhaust ExposureOTHER

Diesel exposure to different concentrations at different times: 20, 50 and 150ug/m3

Diesel Exhaust Exposure

Eligibility Criteria

Age19 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • Non-smokers
  • No physician diagnosed asthma

You may not qualify if:

  • Pregnant/breastfeeding
  • Using inhaled corticosteroids
  • Co-existing medical conditions (as assessed by the primary investigator)
  • Taking part in another study that involves taking medications.
  • Abnormal lung function based on screening spirometry
  • Cardiac diagnosis or arrhythmia is discovered during the screening process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia - VGH site

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (4)

  • Guest PC, Gottschalk MG, Bahn S. Proteomics: improving biomarker translation to modern medicine? Genome Med. 2013 Feb 27;5(2):17. doi: 10.1186/gm421. eCollection 2013. No abstract available.

    PMID: 23445684BACKGROUND

  • Huang W, Smith TJ, Ngo L, Wang T, Chen H, Wu F, Herrick RF, Christiani DC, Ding H. Characterizing and biological monitoring of polycyclic aromatic hydrocarbons in exposures to diesel exhaust. Environ Sci Technol. 2007 Apr 15;41(8):2711-6. doi: 10.1021/es062863j.

    PMID: 17533828BACKGROUND

  • Morgott DA. Factors and Trends Affecting the Identification of a Reliable Biomarker for Diesel Exhaust Exposure. Crit Rev Environ Sci Technol. 2014 Aug;44(16):1795-1864. doi: 10.1080/10643389.2013.790748.

    PMID: 25170242BACKGROUND

  • Orach J, Rider CF, Yuen ACY, Schwartz C, Mookherjee N, Carlsten C. Controlled Diesel Exhaust Exposure Induces a Concentration-dependent Increase in Airway Inflammation: A Clinical Trial. Ann Am Thorac Soc. 2023 Jun;20(6):834-842. doi: 10.1513/AnnalsATS.202209-762OC.

    PMID: 36930796DERIVED

Study Officials

  • Christopher Carlsten, MD, MPH

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 25, 2017

First Posted

July 31, 2017

Study Start

September 27, 2017

Primary Completion

July 16, 2021

Study Completion

July 16, 2021

Last Updated

November 2, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)