Airway InflammationHIPWOODSNCT00673907
HIPWOODS - Health Effects Related to Exposure to Particle Pollution From Woodburning Stoves
A study testing Wood smoke particles in people with Airway Inflammation and Systemic Inflammation, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study intends to focus on health effects and symptoms related to particle exposure from wood burning stoves The objective is to determine whether moderate exposure to particles from wood smoke in a real life situation causes an systemic inflammatory response in peripheral blood or in lower airways. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Inflammation, Systemic Inflammation
- What is being tested?
- Wood smoke particles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2007to Nov 2009
- Phase
- Interventional
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Twenty-four, non-smoking atopic volunteers with normal lung function and bronchial reactivity are recruited for the study. Atopy is determined by skin-prick testing to common aeroallergens.
Who cannot join
- Smokers, pregnant women and other subjects with current or previous diseases, which could involve a risk for the subject or possibly influence the outcome measurements, will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Environmental and Occupational Medicine , Institute of Public Health , The Faculty of Health Sciences
Aarhus C, 8000
About this study
Official title: Health Effects Related to Exposure to Particle Pollution From Woodburning
The study intends to focus on health effects and symptoms related to particle exposure from wood burning stoves
The objective is to determine whether moderate exposure to particles from wood smoke in a real life situation causes an systemic inflammatory response in peripheral blood or in lower airways. 24 healthy subjects (normal healthy subjects and mild asthmatics to study the asthmatic response) is selected for the study. A randomized double blind crossover procedure will be followed with a PM exposure concentration of 200ug/m3, 400ug/m3 or clean air as the control exposure. Exposure will take place in a climate chamber using wood burning in an appropriate wood stove.
Read the detailed description
Public health is concerned with the physical, mental and environmental health of communities and populations at risk for disease and injury. Generally, the determination of health effects associated with indoor and outdoor exposures is difficult since documented cause-and-effect relationships are rare and the exposure and dosage data is sparse. Information about actual human exposure to different types of pollution has several important uses, including informing risk assessments, helping predict the potential consequences of exposures, and developing exposure criteria for regulations and other public policy guidance.
Wood-burning stoves have been a popular heating source for decades. Unfortunately, wood-burning stoves can emit substantial quantities of pollutants to outdoor and indoor air. Among the pollutants are: chlorinated dioxin, carbon monoxide, methane, volatile organic compounds (VOC), nitrogen oxides, polycyclic aromatic hydrocarbons (PAH), and fine particulate matter (PM10, PM2.5, fine and ultra fine particles). Recent studies indicate that the use of wood-burning stoves for heating of dwellings is one of the important outdoor particle sources [Glasius et al. 2004] in residential district in Denmark. This has resulted in an increase in public exposure to indoor and outdoor wood smoke related pollutants, which has prompted widespread concern about the adverse human health consequences that may be associated with wood smoke exposure.
Air pollution is a major aggravation of respiratory symptoms and disease. Effects are decreases in pulmonary function and evidence of inflammation as well as suggestions of increases in chronic respiratory disease. Orozco-Levi et al. (2006) showed strong association between wood smoke exposure and obstructive pulmonary disease. Several studies have shown that especially the small particles, has an effect on airways, and that asthmatic subjects may be the group at greatest risk from air pollutants. The awareness of the impact of airborne particles, particularly fine and ultra fine particles, on health is growing. In recent years, exposure to fine and ultra fine airborne particles has been identified as an important factor affecting human health [Seaton et al., 1995; Schwartz et al., 1996; Oberdörster et al., 1994; Alvin et al., 2000]. Several researchers hypothesize that an increased mortality is associated with the particle levels prevailing in urban air [Jamriska et al., 1999; Dockery et al., 1993]. Mølhave et al (2000; 2005) have suggested that reactive short-lived compounds resulting from reactions between ozone and particulate matter cause indoor air quality complaints and objective health effects such as impaired lung functions.
Particulate air pollution is also known to increase cardiovascular morbidity and mortality. Still the existing scientific knowledge and foundation for evaluating the underlying mechanisms and influence of particle exposure on human immune system are limited. Wood smoke particles, at levels that can be found in smoky indoor environments, seem to affect inflammation. Barregard et al observed a significant increase in S-Amyloid and Faktor VIII/vWf after 0, 3 and 20 hours of exposure to wood smoke. After 20 hours also and increase in Faktor VIII was registred. Surpise-lingly, an IL.-6 decrease was observed after 3 hours. [Barregard et al, 2006]. The particles may also act by increasing blood coagulation factors [Seaton et al 1995]. Both effects may be involved in the mechanisms whereby particulate air pollution affects cardiovascular morbidity and mortality.
- Conditions
- Airway Inflammation, Systemic Inflammation
- Being tested
- Wood smoke particles
- Keywords
- Wood smoke, Health effects, Human, Airway inflammation, Cardiovascular effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wood smoke particlesOther
Subjects are exposed at rest to the exposures for 3 h in our climate chamber
| Study group | Role | What they receive |
|---|---|---|
| 1 | Sham comparator | Clean air Receives: Other: Wood smoke particles |
| 2 | Experimental | Wood smoke particle concentration of 200 ug/m3 Receives: Other: Wood smoke particles |
| 3 | Experimental | Wood smoke particle concentration of 400 ug/m3 Receives: Other: Wood smoke particles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Different Inflammation Biomarkers
Measured: Baseline and follow up measurement after exposure 0 hours post, a 6 hours post and 20 hours post.
Secondary outcomes (1)
Baseline and follow up measurements are: spirometry, exhaled breath condensate, nasal lavage, nasal patency, blood sampling and symptoms.
Measured: Baseline and follow up measurement after exposure 0 hours post, a 6 hours post and 20 hours post.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startJan 2007
- Primary completionJun 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway InflammationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Torben Sigsgaard, Professor, Principal investigator, Department of Environmental and Occupational Medicine , Institute of Public Health , The Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673907
- Sponsor's protocol ID
- 2104-05-0003
- Other IDs
- Projekt nr: 0502-
- Acronym
- HIPWOODS
- Status last verified
- Feb 2012
- First submitted
- 5 May 2008
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects Related to Exposure to Particle Pollution From Woodburning
- ClinicalTrials.gov ID
- NCT00673907
- Acronym / sponsor ID
- HIPWOODS / 2104-05-0003
- Conditions
- Airway Inflammation, Systemic Inflammation
- Keywords
- Wood smoke, Health effects, Human, Airway inflammation, Cardiovascular effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Copenhagen, Aarhus University Hospital
- Study start
- Jan 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 7 May 2008 (estimated)
- 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.
The study intends to focus on health effects and symptoms related to particle exposure from wood burning stoves
The objective is to determine whether moderate exposure to particles from wood smoke in a real life situation causes an systemic inflammatory response in peripheral blood or in lower airways. 24 healthy subjects (normal healthy subjects and mild asthmatics to study the asthmatic response) is selected for the study. A randomized double blind crossover procedure will be followed with a PM exposure concentration of 200ug/m3, 400ug/m3 or clean air as the control exposure. Exposure will take place in a climate chamber using wood burning in an appropriate wood stove.
Detailed description
Public health is concerned with the physical, mental and environmental health of communities and populations at risk for disease and injury. Generally, the determination of health effects associated with indoor and outdoor exposures is difficult since documented cause-and-effect relationships are rare and the exposure and dosage data is sparse. Information about actual human exposure to different types of pollution has several important uses, including informing risk assessments, helping predict the potential consequences of exposures, and developing exposure criteria for regulations and other public policy guidance.
Wood-burning stoves have been a popular heating source for decades. Unfortunately, wood-burning stoves can emit substantial quantities of pollutants to outdoor and indoor air. Among the pollutants are: chlorinated dioxin, carbon monoxide, methane, volatile organic compounds (VOC), nitrogen oxides, polycyclic aromatic hydrocarbons (PAH), and fine particulate matter (PM10, PM2.5, fine and ultra fine particles). Recent studies indicate that the use of wood-burning stoves for heating of dwellings is one of the important outdoor particle sources [Glasius et al. 2004] in residential district in Denmark. This has resulted in an increase in public exposure to indoor and outdoor wood smoke related pollutants, which has prompted widespread concern about the adverse human health consequences that may be associated with wood smoke exposure.
Air pollution is a major aggravation of respiratory symptoms and disease. Effects are decreases in pulmonary function and evidence of inflammation as well as suggestions of increases in chronic respiratory disease. Orozco-Levi et al. (2006) showed strong association between wood smoke exposure and obstructive pulmonary disease. Several studies have shown that especially the small particles, has an effect on airways, and that asthmatic subjects may be the group at greatest risk from air pollutants. The awareness of the impact of airborne particles, particularly fine and ultra fine particles, on health is growing. In recent years, exposure to fine and ultra fine airborne particles has been identified as an important factor affecting human health [Seaton et al., 1995; Schwartz et al., 1996; Oberdörster et al., 1994; Alvin et al., 2000]. Several researchers hypothesize that an increased mortality is associated with the particle levels prevailing in urban air [Jamriska et al., 1999; Dockery et al., 1993]. Mølhave et al (2000; 2005) have suggested that reactive short-lived compounds resulting from reactions between ozone and particulate matter cause indoor air quality complaints and objective health effects such as impaired lung functions.
Particulate air pollution is also known to increase cardiovascular morbidity and mortality. Still the existing scientific knowledge and foundation for evaluating the underlying mechanisms and influence of particle exposure on human immune system are limited. Wood smoke particles, at levels that can be found in smoky indoor environments, seem to affect inflammation. Barregard et al observed a significant increase in S-Amyloid and Faktor VIII/vWf after 0, 3 and 20 hours of exposure to wood smoke. After 20 hours also and increase in Faktor VIII was registred. Surpise-lingly, an IL.-6 decrease was observed after 3 hours. [Barregard et al, 2006]. The particles may also act by increasing blood coagulation factors [Seaton et al 1995]. Both effects may be involved in the mechanisms whereby particulate air pollution affects cardiovascular morbidity and mortality.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Sham comparator | Other: Wood smoke particlesClean air |
| 2 | Experimental | Other: Wood smoke particlesWood smoke particle concentration of 200 ug/m3 |
| 3 | Experimental | Other: Wood smoke particlesWood smoke particle concentration of 400 ug/m3 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Twenty-four, non-smoking atopic volunteers with normal lung function and bronchial reactivity are recruited for the study. Atopy is determined by skin-prick testing to common aeroallergens.
Key exclusion criteria (1 listed)
- Smokers, pregnant women and other subjects with current or previous diseases, which could involve a risk for the subject or possibly influence the outcome measurements, will be excluded from the study.
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 particlesSubjects are exposed at rest to the exposures for 3 h in our climate chamber | Other | 1, 2, 3 |
Primary outcome
Different Inflammation Biomarkers
Time frame: Baseline and follow up measurement after exposure 0 hours post, a 6 hours post and 20 hours post.
1 secondary outcome
Baseline and follow up measurements are: spirometry, exhaled breath condensate, nasal lavage, nasal patency, blood sampling and symptoms.
Time frame: Baseline and follow up measurement after exposure 0 hours post, a 6 hours post and 20 hours post.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
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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.
Torben Sigsgaard, Professor principal investigator
Department of Environmental and Occupational Medicine , Institute of Public Health , The Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wood smoke particles in people with Airway Inflammation and Systemic Inflammation, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Feb 2012. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Different Inflammation Biomarkers (time frame: Baseline and follow up measurement after exposure 0 hours post, a 6 hours post and 20 hours post.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2012.