Woodsmoke Exposure and Cardiovascular Function

NCT ID: NCT01488500

Last Updated: 2012-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Inflammation Systemic Inflammation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Filtered air exposure

3 hour exposure to filtered air with intermittent exercise

Group Type EXPERIMENTAL

Bronchoscopy

Intervention Type OTHER

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.

Wood smoke exposure

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

Group Type EXPERIMENTAL

Bronchoscopy

Intervention Type OTHER

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.

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

Group Type EXPERIMENTAL

Bronchoscopy

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Umeå University

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jeremy Langrish

Clinical Lecturer and Specialty Registrar in Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Sandström, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Umeå University

Umeå, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26511835 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24667535 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23742058 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WOODSMOKE II

Identifier Type: -

Identifier Source: org_study_id