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NCT00807183 · ClinicalTrials.gov registry record · Phase 3
Indoor Woodsmoke PM and Asthma
A Phase 3 study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- Phase 3
- Development phase
- 122
- Enrollment target
NCT00807183: Completed Phase 3 study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT00807183 is a Phase 3 study that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 122 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00807183, a Phase 3 study, has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 122 participants
- Enrollment target
Study 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
Interventions
- OTHER woodstove
- OTHER inactive air filter
- OTHER Active air filter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2008-12 |
| Est. Completion | 2015-01 |
| Phase | Phase 3 |
What the finished NCT00807183 record still lists
NCT00807183 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 3 interventions - of which woodstove is the first listed.
NCT00807183 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00807183 about?
NCT00807183 is a clinical study titled "Indoor Woodsmoke PM and Asthma". 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 man...
What is the current status of trial NCT00807183?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 122 participants. The study started on 2008-12. Estimated completion is 2015-01.
What interventions are being tested in trial NCT00807183?
The interventions under investigation include: woodstove (OTHER), inactive air filter (OTHER), Active air filter (OTHER).
Who is sponsoring clinical trial NCT00807183?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00807183's enrollment target sits among peer trials
122 1617th of 2000 higher than 382 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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