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Trial record 49 of 4738 for:    British | Canada

Human Study to Develop a Signature of Occupational Diesel Exhaust Exposure (DICE)

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ClinicalTrials.gov Identifier: NCT03234790
Recruitment Status : Recruiting
First Posted : July 31, 2017
Last Update Posted : July 24, 2018
Sponsor:
Collaborators:
Government of Alberta
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
Christopher Carlsten, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Experimental Other: Filtered Air Exposure Other: Diesel Exhaust Exposure Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: A Controlled Dose-Response Human Study to Develop a Signature of Occupational Diesel Exhaust Exposure
Actual Study Start Date : September 27, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : April 30, 2020

Arm Intervention/treatment
Active Comparator: Filtered Air Exposure
Exposure for 4 hours to filtered air
Other: Filtered Air Exposure
Exposure to Filtered air

Experimental: Diesel Exhaust Exposure
Volunteers exposed to different concentrations of diesel exhaust
Other: Diesel Exhaust Exposure
Diesel exposure to different concentrations at different times: 20, 50 and 150ug/m3




Primary Outcome Measures :
  1. Serum proteome in response to DE exposure [ Time Frame: 4 hours & 24 hours ]
    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


Secondary Outcome Measures :
  1. Urine proteins in response to DE exposure [ Time Frame: 4 hours & 24 hours ]
    Urine from each experimental condition will be analyzed by liquid mass chromatography to observe any changes between the baseline and listed time points.

  2. Polycyclic Aromatic Hydrocarbons (PAH) metabolites in response to DE exposure [ Time Frame: 4 hours & 24 hours ]
    PAH metabolites in urine samples will be analyzed by HPLC to observe any changes between the baseline and listed time points.

  3. Sleep quality [ Time Frame: baseline versus 24 hours post-exposure ]
    Sleep quality will be assessed by level 3 overnight monitor and questionnaires



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Ages Eligible for Study:   19 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 19-49 years
  2. Non-smokers
  3. No physician diagnosed asthma

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234790


Contacts
Contact: Christopher Carlsten, MD, MPH 604-875-4122 carlsten@mail.ubc.ca
Contact: Agnes Yuen, BSc 604-875-4111 ext 66455 agnes.yuen@ubc.ca

Locations
Canada, British Columbia
University of British Columbia - VGH site Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Research Coordinator    604-875-5132    de.study@ubc.ca   
Sponsors and Collaborators
University of British Columbia
Government of Alberta
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Christopher Carlsten, MD, MPH University of British Columbia

Publications:
Responsible Party: Christopher Carlsten, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03234790     History of Changes
Other Study ID Numbers: H16-03053
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christopher Carlsten, University of British Columbia:
Diesel Exhaust
Air Pollution
Airway Responsiveness
Proteomics
Urine PAH Metabolites