Text Size

Woodsmoke Exposure and Cardiovascular Function

This study has been completed.
Sponsor:
Collaborator:
Umeå University
Information provided by (Responsible Party):
Jeremy Langrish, University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01488500
First received: December 6, 2011
Last updated: August 3, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Respiratory Inflammation
Systemic Inflammation
 Other: Bronchoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cardiovascular Effects of Experimental Exposure to Woodsmoke in Man

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Respiratory inflammation [ Time Frame: 24 hours after exposure to air or woodsmoke ] [ Designated as safety issue: No ]
    Bronchoscopy will be performed, and samples collected by bronchoalveolar lavage and bronchial biopsy. Samples will be analysed for cell counts, histology and inflammatory markers.


Secondary Outcome Measures:
  • Central arterial stiffness [ Time Frame: Baseline and for 1 hour after exposure ] [ Designated as safety issue: No ]
    Central arterial stiffness will be measured at baseline and for the 1 hour following the exposure using the SphygmoCor and Vicorder devices

  • Heart rate variability [ Time Frame: 24 hours after the exposure ] [ Designated as safety issue: No ]
    Continuous electrocardiograms will be recorded using a holter monitor to determine heart rate variability

  • Systemic inflammation [ Time Frame: 24 hours after the exposure ] [ Designated as safety issue: No ]
    Blood samples will be taken at intervals following the exposure to woodsmoke to measure circulating inflammatory markers

  • Lung function [ Time Frame: Baseline and 24hrs after exposure ] [ Designated as safety issue: No ]
    Lung function will be assessed using spirometry before and after each exposure


Estimated Enrollment: 20
Study Start Date: November 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Filtered air exposure
3 hour exposure to filtered air with intermittent exercise
 Other: Bronchoscopy
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
 Other: Bronchoscopy
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
 Other: Bronchoscopy
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488500

Locations
Sweden
Umeå University
Umeå, Sweden
Sponsors and Collaborators
University of Edinburgh
Umeå University
Investigators
Principal Investigator: Thomas Sandström, MD PhD Umeå University
  More Information

No publications provided

Responsible Party: Jeremy Langrish, Clinical Lecturer and Specialty Registrar in Cardiology, University of Edinburgh
ClinicalTrials.gov Identifier: NCT01488500     History of Changes
Other Study ID Numbers: WOODSMOKE II
Study First Received: December 6, 2011
Last Updated: August 3, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University of Edinburgh:
Wood smoke
inflammation
lung function
 arterial stiffness
heart rate variability
Respiratory and systemic inflammation following exposure to woodsmoke in healthy volunteers

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013