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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):
Anthony J. Ward, National Institute of Environmental Health Sciences (NIEHS)

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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Detailed Description:

SPECIFIC AIMS Although particulate matter (PM) exposures have been linked with poor respiratory health outcomes, most of these studies have focused on populated airsheds with urban and industrial sources of PM2.5. In less-urban areas, residential woodstoves are not only major sources of ambient PM2.5, but can result in significant woodsmoke exposures in the indoor environment. This study will focus on indoor air quality and associated health effects among asthmatic children 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. This study will allow us to characterize the woodsmoke effects on asthmatic conditions and evaluate clinically meaningful health outcomes among asthmatics. This will be the first randomized controlled trial in the US to utilize a woodsmoke-targeted intervention and 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 or cooking.

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. One intervention that will be tested in this trial will be the replacement of old woodstoves with cleaner burning EPA-certified woodstoves (Tx2). The other intervention that will be tested will be the installation of HEPA filtration devices within the home (Tx3). Our preliminary data have demonstrated significant reductions in indoor PM using these interventions.

The Primary Aim of this study is to assess the impact on quality of life among asthmatic children following interventions that reduce in-home woodsmoke PM exposures. We will address the following primary hypotheses:

1a. Asthmatic children in homes receiving new woodstoves in Tx2 will have improved asthma-specific quality of life measures compared to asthmatic children in placebo households, Tx1.

  1. b. Asthmatic children in homes receiving HEPA filtration units in Tx3 will have improved asthma-specific quality of life measures compared to asthmatic children in placebo households, Tx1.

    The Secondary Aims of this study are to assess the impact of these interventions on residential PM2.5 exposures and other health outcomes. We will address the following secondary hypotheses:

  2. a. Changes in winter period PM2.5 exposure in homes receiving interventions (Tx2 and Tx3) will be greater than changes in winter period PM2.5 exposure in placebo households (Tx1). Each treatment group will be evaluated independently against the placebo group. Secondary residential exposure outcomes measured repeatedly during pre- and post-intervention winter periods will include:

    1. PM2.5 mass
    2. chemical woodsmoke markers on PM2.5 filters (i.e., levoglucosan and abietic acids)
    3. biomarkers of woodsmoke exposure in urine and exhaled breath condensate (i.e., levoglucosan and abietic acids)

2b. Changes in winter period health outcomes among asthmatic children living in homes receiving interventions (Tx2 and Tx3) will be more improved than changes in winter period health outcomes in placebo households (Tx1). Each treatment group will be evaluated independently against the placebo group. Secondary exposure outcomes will include:

  1. peak expiratory flow (PEF) and forced expiratory volume in first second (FEV1)
  2. biomarkers in exhaled breath condensate (i.e., pH and nitric oxide)
  3. frequency of asthma symptoms
  4. frequency of rescue medication usage
  5. healthcare utilization

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
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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




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


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:


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

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