Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

HIPWOODS - Health Effects Related to Exposure to Particle Pollution From Woodburning Stoves

This study has been completed.
Sponsor:
Collaborators:
University of Copenhagen
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00673907
First received: May 5, 2008
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Airway Inflammation
Systemic Inflammation
Other: Wood smoke particles

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Health Effects Related to Exposure to Particle Pollution From Woodburning

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Different Inflammation Biomarkers [ Time Frame: Baseline and follow up measurement after exposure 0 hours post, a 6 hours post and 20 hours post. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: January 2007
Study Completion Date: November 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 1
Clean air
Other: Wood smoke particles
Subjects are exposed at rest to the exposures for 3 h in our climate chamber
Experimental: 2
Wood smoke particle concentration of 200 ug/m3
Other: Wood smoke particles
Subjects are exposed at rest to the exposures for 3 h in our climate chamber
Experimental: 3
Wood smoke particle concentration of 400 ug/m3
Other: Wood smoke particles
Subjects are exposed at rest to the exposures for 3 h in our climate chamber

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673907

Locations
Denmark
Institute of Environmental and Occupational Medicine , Institute of Public Health , The Faculty of Health Sciences
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
University of Copenhagen
Aarhus University Hospital
Investigators
Principal Investigator: Torben Sigsgaard, Professor Department of Environmental and Occupational Medicine , Institute of Public Health , The Faculty of Health Sciences
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00673907     History of Changes
Other Study ID Numbers: 2104-05-0003, Projekt nr: 0502-
Study First Received: May 5, 2008
Last Updated: February 1, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Wood smoke
Health effects
Human
Airway inflammation
Cardiovascular effects

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014