Pulmonary Effects of 100% Biodiesel Exhaust (BD100Broncho)

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.

Study Overview

• Status: Completed
• Conditions: Inflammation
• Intervention / Treatment: Other: Bronchoscopy

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Filtered air exposure; One hour exposure to filtered air during intermittent exercise in controlled chamber, 6 hours after exposure bronchoscopy is performed.	Other: Bronchoscopy; 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.
Experimental: Biodiesel exhaust exposure; 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.	Other: Bronchoscopy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytokines in Bronchial wash (BW)	Bronchial wash (BW) collected by bronchoscopy will be analyzed for cytokines (%).	6 hours
Cell counts in Bronchial Wash	Bronchial wash (BW) collected by bronchoscopy will be analyzed for inflammatory cell counts (cells/ml).	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxylipin Metabolomic profiling	Metabolomic testing done with mass spectrometry on blood samples, BW and BAL.	Baseline, 2 hours, 6 hours, 24 hours
Inflammation in bronchoalveolar lavage (BAL)	BAL collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/ml).	6 hour
Inflammation in endomucosal biopsies	Biopsies collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/mm2).	6 hours

Collaborators and Investigators

• Sponsor: Umeå University

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Estimate): March 21, 2016
• Last Update Submitted That Met QC Criteria: March 18, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Air Pollution; Biodiesel exhaust; Bronchoscopy; Metabolomics
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 184-31M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No