Woodsmoke Exposure and Cardiovascular Function

August 3, 2012 updated by: Jeremy Langrish, University of Edinburgh

Cardiovascular Effects of Experimental Exposure to Woodsmoke in Man

Air pollution is linked to respiratory and cardiovascular disease. Wood smoke is a common air in many parts of the world and previous studies indicate that wood smoke induce oxidative stress in the respiratory tract. It is not determined how different types of biomass combustion affect human health. In this study the investigators plan to investigate how inhalation of wood smoke and pellets smoke affect respiratory and cardiovascular health.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Umeå, Sweden
        • Umea University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Use of regular medication except the oral contraceptive pill
  • Current smokers
  • Significant occupation exposure to air pollution
  • Intercurrent illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Filtered air exposure
3 hour exposure to filtered air with intermittent exercise
24 hours after exposure, a bronchoscopy will be performed to allow analysis of cells and inflammatory markers in bronchial wash, bronchioalveolar lavage and lung biopsies.
EXPERIMENTAL: Wood smoke exposure
3 hour exposure to dilute wood smoke generated from incomplete combustion in a wood burning stove at approximately 300 mcg/m3
24 hours after exposure, a bronchoscopy will be performed to allow analysis of cells and inflammatory markers in bronchial wash, bronchioalveolar lavage and lung biopsies.
EXPERIMENTAL: Wood pellet smoke emission
3 hour exposure to dilute wood smoke generated from wood pellets during incomplete combustion during intermittent exercise at approximately 300 mcg/m3
24 hours after exposure, a bronchoscopy will be performed to allow analysis of cells and inflammatory markers in bronchial wash, bronchioalveolar lavage and lung biopsies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory inflammation
Time Frame: 24 hours after exposure to air or woodsmoke
Bronchoscopy will be performed, and samples collected by bronchoalveolar lavage and bronchial biopsy. Samples will be analysed for cell counts, histology and inflammatory markers.
24 hours after exposure to air or woodsmoke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central arterial stiffness
Time Frame: Baseline and for 1 hour after exposure
Central arterial stiffness will be measured at baseline and for the 1 hour following the exposure using the SphygmoCor and Vicorder devices
Baseline and for 1 hour after exposure
Heart rate variability
Time Frame: 24 hours after the exposure
Continuous electrocardiograms will be recorded using a holter monitor to determine heart rate variability
24 hours after the exposure
Systemic inflammation
Time Frame: 24 hours after the exposure
Blood samples will be taken at intervals following the exposure to woodsmoke to measure circulating inflammatory markers
24 hours after the exposure
Lung function
Time Frame: Baseline and 24hrs after exposure
Lung function will be assessed using spirometry before and after each exposure
Baseline and 24hrs after exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

December 6, 2011

First Submitted That Met QC Criteria

December 7, 2011

First Posted (ESTIMATE)

December 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 6, 2012

Last Update Submitted That Met QC Criteria

August 3, 2012

Last Verified

August 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Inflammation

Clinical Trials on Bronchoscopy

3
Subscribe