Pulmonary and Systemic Effects of Exposure to Wood Smoke

NCT03302117 | Unknown

• 1 other identifier: WSIII
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is study is to assess pulmonary and systemic effects of exposure to wood smoke. Healthy volunteers will be expose under two different occasion to wood smoke and filtered air under two separated occasions with an interval of 3 weeks in-between. The aim of this study was to determine whether exposure to wood smoke from incomplete combustion would elicit airway inflammation in humans.

Conditions

Pulmonary Inflammation; Cytotoxicity

Keywords

Wood smoke; Bronchoscopy

Outcome Measures

Primary Outcomes (3)

• Pulmonary inflammation

  Flexible bronchoscopy will done to obtain bronchoalveolar lavage to assess the inflammatory responses by measurement of cell differential counts and cytokines level.

  Bronchoscopy will be done 6 hours after each exposure.

• Pulmonary cytotoxicity

  Bronchoalveolar lavage will be examined for signs of cytotoxicity by measurement of cell death and apoptosis markers.

  Bronchoscopy will be done 6 hours after each exposure.

• Inflammatory changes in endobronchial biopsies

  Endobronchial biopsies will be obtained by using flexible bronchoscopy. The biopsies will be stained by using immunohistochemistry method for assessing the inflammatory responses after each exposures

  Bronchoscopy will be done 6 hours after each exposure and the processing of the immunohistochemistry method will start immediately after each bronchoscopy

Secondary Outcomes (2)

• Systemic inflammatory responses

  Before and 6 hour after each exposure

• Lung function test

  At baseline, immediately after and 6 hours after each exposure

Interventions

Wood smoke exposure OTHER

Healthy volunteers will exposed to filtered air alternate with wood smoke generated from incomplete wood smoke combustion to assess the local and systemic effect of theses exposures

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Twenty healthy volunteers (age 20-40, all never smokers) will included. All subjects undergo a physical examination, baseline blood count and renal function assessment, spirometry (FEV1, VC and FEV1/VC) and 12 lead electrocardiogram prior to inclusion. All must be free of airway infection for at least 6 weeks prior to participation. The study was approved by the regional ethical review board and performed in accordance with the declaration of Helsinki. All subjects should give their written informed consent.

You may qualify if:

• Healthy volunteers
• Non-smoker
• Non-allergic

You may not qualify if:

• Diabetes Mellitus
• Renal failure
• Ischemic heart disease
• History of hematological disease
• Previous smoking.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Department for Public Health and Clinical Medicine

Umeå, 90187, Sweden

RECRUITING

Related Publications (6)

• Friedrich MJ. UNICEF Reports on the Impact of Air Pollution on Children. JAMA. 2017 Jan 17;317(3):246. doi: 10.1001/jama.2016.19034. No abstract available.

  PMID: 28114563 BACKGROUND

• Po JY, FitzGerald JM, Carlsten C. Respiratory disease associated with solid biomass fuel exposure in rural women and children: systematic review and meta-analysis. Thorax. 2011 Mar;66(3):232-9. doi: 10.1136/thx.2010.147884. Epub 2011 Jan 19.

  PMID: 21248322 BACKGROUND

• Hu G, Zhou Y, Tian J, Yao W, Li J, Li B, Ran P. Risk of COPD from exposure to biomass smoke: a metaanalysis. Chest. 2010 Jul;138(1):20-31. doi: 10.1378/chest.08-2114. Epub 2010 Feb 5.

  PMID: 20139228 BACKGROUND

• Kurmi OP, Semple S, Simkhada P, Smith WC, Ayres JG. COPD and chronic bronchitis risk of indoor air pollution from solid fuel: a systematic review and meta-analysis. Thorax. 2010 Mar;65(3):221-8. doi: 10.1136/thx.2009.124644.

  PMID: 20335290 BACKGROUND

• 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: 23742058 BACKGROUND

• Rudell B, Ledin MC, Hammarstrom U, Stjernberg N, Lundback B, Sandstrom T. Effects on symptoms and lung function in humans experimentally exposed to diesel exhaust. Occup Environ Med. 1996 Oct;53(10):658-62. doi: 10.1136/oem.53.10.658.

  PMID: 8943829 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bronchoalevolar lavage. Endobronchial biopsies. Peripheral blood sampling.

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ala Muala, MD, PhD

  Department for Public Health and Clinical Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ala Muala, MD, PhD

CONTACT

+46907851785; ala.muala@umu.se

Thomas Sandström, MD, PhD

CONTACT

+46907852516; thomas.sandstrom@umu.se

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: October 4, 2017
• Study Start: June 14, 2017
• Primary Completion: February 8, 2018
• Study Completion: February 8, 2018
• Last Updated: October 4, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)