- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01488500
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
Conditions
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.
Sponsor
Collaborators
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.
General Publications
- 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.
- 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.
- 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.
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WOODSMOKE II
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.
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