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OpenTrials
Completed

NCT Number: NCT02690571

Pulmonary Effects of 100% Biodiesel Exhaust

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bronchoscopy

Other

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 outcomes

  1. Cytokines in Bronchial wash (BW)

    Time frame: 6 hours

    Bronchial wash (BW) collected by bronchoscopy will be analyzed for cytokines (%).

  2. Cell counts in Bronchial Wash

    Time frame: 6 hours

    Bronchial wash (BW) collected by bronchoscopy will be analyzed for inflammatory cell counts (cells/ml).

Secondary outcomes

  1. Oxylipin Metabolomic profiling

    Time frame: Baseline, 2 hours, 6 hours, 24 hours

    Metabolomic testing done with mass spectrometry on blood samples, BW and BAL.

  2. Inflammation in bronchoalveolar lavage (BAL)

    Time frame: 6 hour

    BAL collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/ml).

  3. Inflammation in endomucosal biopsies

    Time frame: 6 hours

    Biopsies collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/mm2).

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Acronym: BD100Broncho

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 24, 2016
Registry last updated
Mar 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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