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Indoor Woodsmoke PM and Asthma (ARTIS)

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ClinicalTrials.gov Identifier: NCT00807183
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : April 15, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Although particulate matter (PM) exposures have been linked with poor respiratory health outcomes, most of these studies have focused on airsheds with urban and industrial sources of PM2.5. Woodsmoke-derived PM also contributes to ambient PM in these urban areas, and is the major source of PM in many US rural or peri-urban areas, as well as in many communities within developing countries. This study will focus on indoor air quality and clinically relevant changes in health effects among asthmatics living in homes whose primary heating sources are non EPA-certified woodstoves. The Primary Aim of this study is to assess the efficacy of residential interventions to reduce indoor PM exposure from woodstoves and the corresponding improvements in quality of life and health outcomes for asthmatic children. The study area for this project will be three rural communities in western Montana and Idaho, including one Indian Reservation. This study will use a three arm (Tx1, Tx2, and Tx3) randomized placebo-controlled intervention trial. The interventions will be at the household level, and exposure and outcomes will be assessed for one asthmatic child in each household. Households in Tx1 will receive inactive high efficiency particulate air (HEPA) devices and will serve as the placebo group. Households in Tx2 will receive a new EPA-certified woodstove, while households in Tx3 will receive active HEPA devices. The Secondary Aims of this study are to assess the impact of these interventions on residential PM2.5 exposures and other health outcomes. Secondary exposure outcomes measured prior to and following the intervention will include PM2.5 mass, chemical woodsmoke markers on PM2.5 filters (including levoglucosan and abietic acids), and biomarkers of woodsmoke exposure. Secondary asthma-related health outcomes measured prior to and following the intervention will include peak expiratory flow (PEF) and forced expiratory volume in first second (FEV1), biomarkers in exhaled breath condensate, and frequency of asthma symptoms, medication usage, and healthcare utilization. To our knowledge, this will be the first randomized trial in the US to utilize a woodsmoke intervention to assess the impact of the consequent reductions in indoor PM on health outcomes in a susceptible population. The results from this project will be translatable to other regions in the US and the world where biomass burning is commonly used for heating and cooking.

Condition or disease Intervention/treatment Phase
Asthma Other: woodstove Other: inactive air filter Other: Active air filter Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Indoor Woodsmoke PM and Asthma: a Randomized Trial
Study Start Date : December 2008
Primary Completion Date : January 2015
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Tx1
Inactive air filter
Other: inactive air filter
air filter units without filter in place
Experimental: Tx2
New EPA-certified woodstove
Other: woodstove
installation of new EPA-certified woodstove
Experimental: Tx3
Active air filter
Other: Active air filter
air filter units correctly operating


Outcome Measures

Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 1 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with moderate to severe asthma living in homes with non EPA-certified woodstove used for heating.

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807183


Locations
United States, Montana
University of Montana
Missoula, Montana, United States, 59812
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Investigators
Principal Investigator: Curtis W Noonan, Ph.D. University of Montana
Principal Investigator: Tony Ward, Ph.D. University of Montana
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anthony J. Ward, Associate Professor, National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT00807183     History of Changes
Other Study ID Numbers: 16336-CP-001
First Posted: December 11, 2008    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases