Indoor Woodsmoke PM and Asthma

NCT00807183 | Completed Phase 3

• 1 other identifier: 16336-CP-001
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  1 month

Study Arms (3)

Tx1

PLACEBO COMPARATOR

Inactive air filter

Other: inactive air filter

Tx2

EXPERIMENTAL

New EPA-certified woodstove

Other: woodstove

Tx3

EXPERIMENTAL

Active air filter

Other: Active air filter

Interventions

woodstove OTHER

installation of new EPA-certified woodstove

Tx2

inactive air filter OTHER

air filter units without filter in place

Tx1

Active air filter OTHER

air filter units correctly operating

Tx3

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

University of Montana

Missoula, Montana, 59812, United States

Location

Related Publications (3)

• Noonan CW, Semmens EO, Smith P, Harrar SW, Montrose L, Weiler E, McNamara M, Ward TJ. Randomized Trial of Interventions to Improve Childhood Asthma in Homes with Wood-burning Stoves. Environ Health Perspect. 2017 Sep 13;125(9):097010. doi: 10.1289/EHP849.

  PMID: 28935614 DERIVED

• Montrose L, Ward TJ, Semmens EO, Cho YH, Brown B, Noonan CW. Dietary intake is associated with respiratory health outcomes and DNA methylation in children with asthma. Allergy Asthma Clin Immunol. 2017 Feb 27;13:12. doi: 10.1186/s13223-017-0187-8. eCollection 2017.

  PMID: 28261276 DERIVED

• Noonan CW, Ward TJ. Asthma randomized trial of indoor wood smoke (ARTIS): rationale and methods. Contemp Clin Trials. 2012 Sep;33(5):1080-7. doi: 10.1016/j.cct.2012.06.006. Epub 2012 Jun 23.

  PMID: 22735495 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Curtis W Noonan, Ph.D.

  University of Montana

  PRINCIPAL INVESTIGATOR

• Tony Ward, Ph.D.

  University of Montana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: December 1, 2008
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

US (1)