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Woodsmoke Exposure and Cardiovascular Function

Primary Purpose

Respiratory Inflammation, Systemic Inflammation

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Bronchoscopy

About this trial

This is an interventional basic science trial for Respiratory Inflammation focused on measuring Wood smoke, inflammation, lung function, arterial stiffness, heart rate variability, Respiratory and systemic inflammation following exposure to woodsmoke in healthy volunteers

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Umeå University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Filtered air exposure

Wood smoke exposure

Wood pellet smoke emission

Arm Description

3 hour exposure to filtered air with intermittent exercise

3 hour exposure to dilute wood smoke generated from incomplete combustion in a wood burning stove at approximately 300 mcg/m3

3 hour exposure to dilute wood smoke generated from wood pellets during incomplete combustion during intermittent exercise at approximately 300 mcg/m3

Outcomes

Primary Outcome Measures

Respiratory inflammation

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

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

Continuous electrocardiograms will be recorded using a holter monitor to determine heart rate variability

Systemic inflammation

Blood samples will be taken at intervals following the exposure to woodsmoke to measure circulating inflammatory markers

Lung function

Lung function will be assessed using spirometry before and after each exposure

Full Information

NCT ID

NCT01488500

First Posted

December 6, 2011

Last Updated

August 3, 2012

Sponsor

University of Edinburgh

Collaborators

Umeå University

1. Study Identification

Unique Protocol Identification Number

NCT01488500

Brief Title

Woodsmoke Exposure and Cardiovascular Function

Official Title

Cardiovascular Effects of Experimental Exposure to Woodsmoke in Man

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Edinburgh

Collaborators

Umeå University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Inflammation, Systemic Inflammation

Keywords

Wood smoke, inflammation, lung function, arterial stiffness, heart rate variability, Respiratory and systemic inflammation following exposure to woodsmoke in healthy volunteers

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Filtered air exposure

Arm Type

Experimental

Arm Description

3 hour exposure to filtered air with intermittent exercise

Arm Title

Wood smoke exposure

Arm Type

Experimental

Arm Description

3 hour exposure to dilute wood smoke generated from incomplete combustion in a wood burning stove at approximately 300 mcg/m3

Arm Title

Wood pellet smoke emission

Arm Type

Experimental

Arm Description

3 hour exposure to dilute wood smoke generated from wood pellets during incomplete combustion during intermittent exercise at approximately 300 mcg/m3

Intervention Type

Other

Intervention Name(s)

Bronchoscopy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Respiratory inflammation

Description

Bronchoscopy will be performed, and samples collected by bronchoalveolar lavage and bronchial biopsy. Samples will be analysed for cell counts, histology and inflammatory markers.

Time Frame

24 hours after exposure to air or woodsmoke

Secondary Outcome Measure Information:

Title

Central arterial stiffness

Description

Central arterial stiffness will be measured at baseline and for the 1 hour following the exposure using the SphygmoCor and Vicorder devices

Time Frame

Baseline and for 1 hour after exposure

Title

Heart rate variability

Description

Continuous electrocardiograms will be recorded using a holter monitor to determine heart rate variability

Time Frame

24 hours after the exposure

Title

Systemic inflammation

Description

Blood samples will be taken at intervals following the exposure to woodsmoke to measure circulating inflammatory markers

Time Frame

24 hours after the exposure

Title

Lung function

Description

Lung function will be assessed using spirometry before and after each exposure

Time Frame

Baseline and 24hrs after exposure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Sandström, MD PhD

Organizational Affiliation

Umeå University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Umeå University

City

Umeå

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

26511835

Citation

Muala A, Rankin G, Sehlstedt M, Unosson J, Bosson JA, Behndig A, Pourazar J, Nystrom R, Pettersson E, Bergvall C, Westerholm R, Jalava PI, Happo MS, Uski O, Hirvonen MR, Kelly FJ, Mudway IS, Blomberg A, Boman C, Sandstrom T. Acute exposure to wood smoke from incomplete combustion--indications of cytotoxicity. Part Fibre Toxicol. 2015 Oct 29;12:33. doi: 10.1186/s12989-015-0111-7.

Results Reference

derived

PubMed Identifier

24667535

Citation

Langrish JP, Watts SJ, Hunter AJ, Shah AS, Bosson JA, Unosson J, Barath S, Lundback M, Cassee FR, Donaldson K, Sandstrom T, Blomberg A, Newby DE, Mills NL. Controlled exposures to air pollutants and risk of cardiac arrhythmia. Environ Health Perspect. 2014 Jul;122(7):747-53. doi: 10.1289/ehp.1307337. Epub 2014 Mar 25.

Results Reference

derived

PubMed Identifier

23742058

Citation

Unosson J, Blomberg A, Sandstrom T, Muala A, Boman C, Nystrom R, Westerholm R, Mills NL, Newby DE, Langrish JP, Bosson JA. Exposure to wood smoke increases arterial stiffness and decreases heart rate variability in humans. Part Fibre Toxicol. 2013 Jun 6;10:20. doi: 10.1186/1743-8977-10-20.

Results Reference

derived

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Woodsmoke Exposure and Cardiovascular Function

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