NCT02690571

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

February 9, 2016

Last Update Submit

March 18, 2016

Conditions

Inflammation

Keywords

Air PollutionBiodiesel exhaustBronchoscopyMetabolomics

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Oxylipin Metabolomic profiling

    Baseline, 2 hours, 6 hours, 24 hours

  • Inflammation in bronchoalveolar lavage (BAL)

    6 hour

  • Inflammation in endomucosal biopsies

    6 hours

Study Arms (2)

Filtered air exposure

SHAM COMPARATOR

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

Other: Bronchoscopy

Biodiesel exhaust exposure

EXPERIMENTAL

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

Interventions

BronchoscopyOTHER

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.

Biodiesel exhaust exposureFiltered air exposure

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal ECG
  • Normal Lung function
  • Normal Blood samples

You may not qualify if:

  • Smoking
  • Pre-existing metabolomic, respiratory and cardiovascular disease
  • Exposure to high levels of pollutants in occupation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammation

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Jenny A Bosson, MD, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 24, 2016

Study Start

October 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 21, 2016

Record last verified: 2016-03