NCT01488500

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

August 6, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

December 6, 2011

Last Update Submit

August 3, 2012

Conditions

Respiratory InflammationSystemic Inflammation

Keywords

Wood smokeinflammationlung functionarterial stiffnessheart rate variabilityRespiratory and systemic inflammation following exposure to woodsmoke in healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours after exposure to air or woodsmoke

Secondary Outcomes (4)

  • Central arterial stiffness

    Baseline and for 1 hour after exposure

  • Heart rate variability

    24 hours after the exposure

  • Systemic inflammation

    24 hours after the exposure

  • Lung function

    Baseline and 24hrs after exposure

Study Arms (3)

Filtered air exposure

EXPERIMENTAL

3 hour exposure to filtered air with intermittent exercise

Other: Bronchoscopy

Wood smoke exposure

EXPERIMENTAL

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

Other: Bronchoscopy

Wood pellet smoke emission

EXPERIMENTAL

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

Other: Bronchoscopy

Interventions

BronchoscopyOTHER

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.

Filtered air exposureWood pellet smoke emissionWood smoke exposure

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå University

Umeå, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 26511835DERIVED

  • 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.

    PMID: 24667535DERIVED

  • 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.

    PMID: 23742058DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Thomas Sandström, MD PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Lecturer and Specialty Registrar in Cardiology

Study Record Dates

First Submitted

December 6, 2011

First Posted

December 8, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

August 6, 2012

Record last verified: 2012-08

Locations

SE(1)