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Pulmonary Effects of 100% Biodiesel Exhaust (BD100Broncho)

Primary Purpose

Inflammation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bronchoscopy
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation focused on measuring Air Pollution, Biodiesel exhaust, Bronchoscopy, Metabolomics

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Normal ECG

Normal Lung function

Normal Blood samples

Exclusion Criteria:

Smoking

Pre-existing metabolomic, respiratory and cardiovascular disease

Exposure to high levels of pollutants in occupation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Filtered air exposure

    Biodiesel exhaust exposure

    Arm Description

    One hour exposure to filtered air during intermittent exercise in controlled chamber, 6 hours after exposure bronchoscopy is performed.

    One hour exposure to biodiesel exhaust (generated at same running conditions as earlier studies with diesel exhaust at approximate particle matter concentration 300 mcg/m3) during intermittent exercise in controlled chamber. Six hours after exposure bronchoscopy is performed.

    Outcomes

    Primary Outcome Measures

    Cytokines in Bronchial wash (BW)
    Bronchial wash (BW) collected by bronchoscopy will be analyzed for cytokines (%).
    Cell counts in Bronchial Wash
    Bronchial wash (BW) collected by bronchoscopy will be analyzed for inflammatory cell counts (cells/ml).

    Secondary Outcome Measures

    Oxylipin Metabolomic profiling
    Metabolomic testing done with mass spectrometry on blood samples, BW and BAL.
    Inflammation in bronchoalveolar lavage (BAL)
    BAL collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/ml).
    Inflammation in endomucosal biopsies
    Biopsies collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/mm2).

    Full Information

    First Posted
    February 9, 2016
    Last Updated
    March 18, 2016
    Sponsor
    Umeå University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02690571
    Brief Title
    Pulmonary Effects of 100% Biodiesel Exhaust
    Acronym
    BD100Broncho
    Official Title
    Pulmonary Effects of 100% Biodiesel Exhaust
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    April 2014 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Umeå University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Air pollution is a global environmental and health concern, contributing to onset and deterioration of respiratory and cardiovascular diseases. As climate change and dependence on diminishing fossil fuel supplies have taken center stage in political and scientific debates, renewable carbon-neutral fuels like biodiesel receive increasing attention. The most common biodiesel within the European Union, rapeseed oil methyl ester (RME) is perceived to be a "green fuel", as it is sustainable and of biological origin, and therefore is often predicted to be less harmful to human health. Whilst replacing petrodiesel with biodiesel may have advantageous ecological impacts, consequences to respiratory health remained largely unexplored. The purpose of the current study is to evaluate whether inhalation of 100% RME biodiesel exhaust would result in an acute airway inflammatory response in healthy human subjects, as shown previously following exposure to petrodiesel exhaust.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammation
    Keywords
    Air Pollution, Biodiesel exhaust, Bronchoscopy, Metabolomics

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Filtered air exposure
    Arm Type
    Sham Comparator
    Arm Description
    One hour exposure to filtered air during intermittent exercise in controlled chamber, 6 hours after exposure bronchoscopy is performed.
    Arm Title
    Biodiesel exhaust exposure
    Arm Type
    Experimental
    Arm Description
    One hour exposure to biodiesel exhaust (generated at same running conditions as earlier studies with diesel exhaust at approximate particle matter concentration 300 mcg/m3) during intermittent exercise in controlled chamber. Six hours after exposure bronchoscopy is performed.
    Intervention Type
    Other
    Intervention Name(s)
    Bronchoscopy
    Intervention Description
    The bronchoscopy procedure was performed six hours after completion of the exposure session, with sampling of endobronchial mucosal biopsies, bronchial wash and bronchoalveolar lavage performed under topical anaesthesia.
    Primary Outcome Measure Information:
    Title
    Cytokines in Bronchial wash (BW)
    Description
    Bronchial wash (BW) collected by bronchoscopy will be analyzed for cytokines (%).
    Time Frame
    6 hours
    Title
    Cell counts in Bronchial Wash
    Description
    Bronchial wash (BW) collected by bronchoscopy will be analyzed for inflammatory cell counts (cells/ml).
    Time Frame
    6 hours
    Secondary Outcome Measure Information:
    Title
    Oxylipin Metabolomic profiling
    Description
    Metabolomic testing done with mass spectrometry on blood samples, BW and BAL.
    Time Frame
    Baseline, 2 hours, 6 hours, 24 hours
    Title
    Inflammation in bronchoalveolar lavage (BAL)
    Description
    BAL collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/ml).
    Time Frame
    6 hour
    Title
    Inflammation in endomucosal biopsies
    Description
    Biopsies collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/mm2).
    Time Frame
    6 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Normal ECG Normal Lung function Normal Blood samples Exclusion Criteria: Smoking Pre-existing metabolomic, respiratory and cardiovascular disease Exposure to high levels of pollutants in occupation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jenny A Bosson, MD, PhD
    Organizational Affiliation
    Umeå University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Pulmonary Effects of 100% Biodiesel Exhaust

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