Pulmonary InflammationNCT03302117
Pulmonary and Systemic Effects of Exposure to Wood Smoke
An observational study of Pulmonary Inflammation and Cytotoxicity, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Inflammation, Cytotoxicity
- What is being tested?
- Wood smoke exposure
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 14 Jun 2017to 8 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Healthy volunteers
- Non-smoker
- Non-allergic
Who cannot join
- Diabetes Mellitus
- Renal failure
- Ischemic heart disease
- History of hematological disease
- Previous smoking.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department for Public Health and Clinical Medicine
Umeå, 90187
Ala Muala, MD, PhD, +467851784, ala.muala@umu.se
Thomas Sandström, MD, PhD, +46907852516, thomas.sandstrom@umu.se
About this study
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.
Read the detailed description
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 to filtered air for two hours 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.
Detailed description Air pollution is associate with increased pulmonary and cardiovascular mobility and mortality. UNICEF recently published a report highlighting the health effects of air pollution from a global perspective, with particular focus on pediatrics population. Overall, air pollution is estimated to cause about 7 million deaths each year in the world, of which about 600,000 of these apply to children under 5 years (1). Indoor and outdoor air pollutants are the 3rd and 9th most common cause of death. Nearly 3 billion people are dependent on biomass for daily needs, Exposure to wood smoke has been linked to elevated asthma prevalence, increased asthma symptoms in children and adults, as well as higher hospital admissions due to asthma attacks. The association between long-term indoor wood smoke exposure and the development and worsening of chronic obstructive pulmonary disease has been shown to be strong in many epidemiological studies (2,3), and the risk for chronic obstructive pulmonary disease development has been estimated to be more than doubled for solid fuel smoke compared with smoke from other types of fuels (4). Exposure to smoke from combustion of wood and other biomass fuels has also been shown to increase the risk for acute and chronic lower respiratory tract infections, including pneumonias and tuberculosis. The aim of the current study was to further characterize the respiratory and systemic effects of exposure to wood smoke emitted from incomplete soot-rich combustion in a wood stove.
The study will be performed in a randomized, double blind, crossover fashion. Twenty healthy subjects will be exposed on two occasions, under well-controlled situations, to filtered air and wood smoke in an exposure chamber at Thermochemical Energy Conversion Laboratory at Umeå University. The chamber is made of stainless steel, has a volume of a 15.3 m3 and an air exchange rate of around three times per hour and has been previously described (5). The mean particle mass concentration of wood smoke will be 450 μg/m3. The exposures will last for two hours, during which the subject will perform intermittent exercise on a bicycle ergometer, alternate with rest at 15-minute intervals, to achieve an average minute ventilation of 20 L/min/m2 body surface. During the exposures, symptoms well be recorded according to the modified Borg scale, as described previously (6). Spirometry and impulse oscillometry system (IOS) will be used to assess the lung function at baseline and immediately after each exposure. Bronchoscopy will be performed 6 hours after each exposure. Differential cell counts and soluble components will be analyzed in peripheral blood sampling at baseline and 6 hours after each exposure.
- Conditions
- Pulmonary Inflammation, Cytotoxicity
- Being tested
- Wood smoke exposure
- Keywords
- Wood smoke, Bronchoscopy
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wood smoke exposureOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary inflammation
Flexible bronchoscopy will done to obtain bronchoalveolar lavage to assess the inflammatory responses by measurement of cell differential counts and cytokines level.
Measured: 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.
Measured: 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
Measured: 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
Peripheral blood samples will be centrifuged at 3,000xg for 30 min at 4 Celsius and then plasma will be removed and frozen at -80 Celsius for further analysis. Plasma samples will be analysed for markers of acute inflammation: Interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α), soluble Intercellular Adhesion Molecule-1 (sICAM-1) and club cell secretory protein 16 (CC16, formerly called clara cell protein 16) using ELISA kits.
Measured: Before and 6 hour after each exposure
Lung function test
Assessment of lung function by using using a spirometer (Jaeger spirometer, Germany). The tests were performed according to the guidelines of the American Thoracic Society. An new method will used here also by using impulse oscillometry system (IOS).
Measured: At baseline, immediately after and 6 hours after each exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start14 Jun 2017
- Primary completion8 Feb 2018 (estimated)
- Study completion8 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary InflammationStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ala Muala, MD, PhD, Principal investigator, Department for Public Health and Clinical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302117
- Sponsor's protocol ID
- WSIII
- Status last verified
- Sep 2017
- First submitted
- 21 Sep 2017
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28114563Po 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.
PubMed 21248322Hu 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.
PubMed 20139228Kurmi 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.
PubMed 20335290Unosson 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.
PubMed 23742058Rudell 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.
PubMed 8943829Sehlin M, Ohberg F, Boman C, Muala A. Acute Controlled Wood Smoke Exposure Induces Sensory Airway Irritation Without Detectable Changes in Small Airway Mechanics in Healthy Adults: A Randomized Crossover Study. Environ Res. 2026 Sep 7:125629. doi: 10.1016/j.envres.2026.125629. Online ahead of print.
PubMed 42705439
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary and Systemic Effects of Exposure to Wood Smoke
- ClinicalTrials.gov ID
- NCT03302117
- Acronym / sponsor ID
- WSIII
- Conditions
- Pulmonary Inflammation, Cytotoxicity
- Keywords
- Wood smoke, Bronchoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 8 Feb 2018 (estimated)
- Study completion
- 8 Feb 2018 (estimated)
- First posted
- 4 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 to filtered air for two hours 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.
Detailed description Air pollution is associate with increased pulmonary and cardiovascular mobility and mortality. UNICEF recently published a report highlighting the health effects of air pollution from a global perspective, with particular focus on pediatrics population. Overall, air pollution is estimated to cause about 7 million deaths each year in the world, of which about 600,000 of these apply to children under 5 years (1). Indoor and outdoor air pollutants are the 3rd and 9th most common cause of death. Nearly 3 billion people are dependent on biomass for daily needs, Exposure to wood smoke has been linked to elevated asthma prevalence, increased asthma symptoms in children and adults, as well as higher hospital admissions due to asthma attacks. The association between long-term indoor wood smoke exposure and the development and worsening of chronic obstructive pulmonary disease has been shown to be strong in many epidemiological studies (2,3), and the risk for chronic obstructive pulmonary disease development has been estimated to be more than doubled for solid fuel smoke compared with smoke from other types of fuels (4). Exposure to smoke from combustion of wood and other biomass fuels has also been shown to increase the risk for acute and chronic lower respiratory tract infections, including pneumonias and tuberculosis. The aim of the current study was to further characterize the respiratory and systemic effects of exposure to wood smoke emitted from incomplete soot-rich combustion in a wood stove.
The study will be performed in a randomized, double blind, crossover fashion. Twenty healthy subjects will be exposed on two occasions, under well-controlled situations, to filtered air and wood smoke in an exposure chamber at Thermochemical Energy Conversion Laboratory at Umeå University. The chamber is made of stainless steel, has a volume of a 15.3 m3 and an air exchange rate of around three times per hour and has been previously described (5). The mean particle mass concentration of wood smoke will be 450 μg/m3. The exposures will last for two hours, during which the subject will perform intermittent exercise on a bicycle ergometer, alternate with rest at 15-minute intervals, to achieve an average minute ventilation of 20 L/min/m2 body surface. During the exposures, symptoms well be recorded according to the modified Borg scale, as described previously (6). Spirometry and impulse oscillometry system (IOS) will be used to assess the lung function at baseline and immediately after each exposure. Bronchoscopy will be performed 6 hours after each exposure. Differential cell counts and soluble components will be analyzed in peripheral blood sampling at baseline and 6 hours after each exposure.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Healthy volunteers
- Non-smoker
- Non-allergic
Key exclusion criteria (5 listed)
- Diabetes Mellitus
- Renal failure
- Ischemic heart disease
- History of hematological disease
- Previous smoking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wood smoke exposureHealthy 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 | Other | – |
Primary outcome
Pulmonary inflammation
Time frame: Bronchoscopy will be done 6 hours after each exposure.
Flexible bronchoscopy will done to obtain bronchoalveolar lavage to assess the inflammatory responses by measurement of cell differential counts and cytokines level.
Pulmonary cytotoxicity
Time frame: Bronchoscopy will be done 6 hours after each exposure.
Bronchoalveolar lavage will be examined for signs of cytotoxicity by measurement of cell death and apoptosis markers.
Inflammatory changes in endobronchial biopsies
Time frame: Bronchoscopy will be done 6 hours after each exposure and the processing of the immunohistochemistry method will start immediately after each bronchoscopy
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
2 secondary outcomes
Systemic inflammatory responses
Time frame: Before and 6 hour after each exposure
Lung function test
Time frame: At baseline, immediately after and 6 hours after each exposure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Background: PubMed 28114563Friedrich 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.
- Background: PubMed 21248322Po 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.
- Background: PubMed 20139228Hu 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.
- Background: PubMed 20335290Kurmi 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.
- Background: PubMed 23742058Unosson 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.
- Background: PubMed 8943829Rudell 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.
- Derived from this study: PubMed 42705439Sehlin M, Ohberg F, Boman C, Muala A. Acute Controlled Wood Smoke Exposure Induces Sensory Airway Irritation Without Detectable Changes in Small Airway Mechanics in Healthy Adults: A Randomized Crossover Study. Environ Res. 2026 Sep 7:125629. doi: 10.1016/j.envres.2026.125629. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ala Muala, MD, PhD principal investigator
Department for Public Health and Clinical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Inflammation and Cytotoxicity, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ala Muala, MD, PhD (+46907851785, ala.muala@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary inflammation (time frame: Bronchoscopy will be done 6 hours after each exposure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03302117, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2017.