Pulmonary Effects of 100% Biodiesel Exhaust

Inflammation Clinical Trial

— BD100Broncho  

Official title:

Pulmonary Effects of 100% Biodiesel Exhaust

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690571
• Other study ID #: 184-31M
• Status: Completed
• Phase: N/A
• First received: February 9, 2016
• Last updated: February 23, 2016
• Start date: October 2013
• Est. completion date: April 2014

Study information

• Verified date: February 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokines in Bronchial wash (BW)	Bronchial wash (BW) collected by bronchoscopy will be analyzed for cytokines (%).	6 hours	No
Primary	Cell counts in Bronchial Wash	Bronchial wash (BW) collected by bronchoscopy will be analyzed for inflammatory cell counts (cells/ml).	6 hours	No
Secondary	Metabolomic profiling	Metabolomic testing done with mass spectrometry on blood samples, BW and BAL.	Baseline, 2 hours, 6 hours, 24 hours	No
Secondary	Inflammation in bronchoalveolar lavage (BAL)	BAL collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/ml).	6 hour	No
Secondary	Inflammation in endomucosal biopsies	Biopsies collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/mm2).	6 hours	No