NCT01570062

Brief Summary

This study is focused on the effects of HEPA filtration to reduce exposures to combustion-derived air pollution (CDAP). Specifically, the study will evaluate the health benefits of HEPA filters and compare the cardiovascular toxicity of two major sources of CDAP, specifically traffic and residential wood combustion. Specifically, the purpose of this study is to evaluate the ability of portable high efficiency particle air (HEPA) filters to reduce exposures to PM2.5 and air pollution indoors and to improve subclinical indicators of microvascular function and systemic inflammation among healthy adult participants. The investigators hypothesize that HEPA filter use will help decrease indoor concentrations of CDAP thereby helping to mitigate the associated cardiovascular risks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

9 months

First QC Date

March 15, 2012

Last Update Submit

April 10, 2014

Conditions

Endothelial DysfunctionSystemic Inflammation

Keywords

InflammationPathologic Processes

Outcome Measures

Primary Outcomes (1)

  • Difference in reactive hyperemia measurement after HEPA filtration

    Participants endothelial function are tested after 1 week of HEPA filtration and after 1 week of non-HEPA filtration (placebo filtration).

    after 1 week of filtration

Secondary Outcomes (1)

  • Difference in C-Reactive Protein after HEPA Filtration

    after 1 week of filtration

Study Arms (2)

Indoor Air HEPA Filtration

ACTIVE COMPARATOR

HEPA filters will be placed in participant's main living area and bedroom. Actual filtration will occur during only one of the two 7-day sampling periods.

Device: HEPA Filter

HEPA Filtration Placebo

PLACEBO COMPARATOR

For one of two 7-day sampling sessions, HEPA filters placed in participants' homes will be run without an actual filter in the housing unit.

Device: HEPA Filtration Placebo

Interventions

HEPA FilterDEVICE

Two HEPA filters will be placed in participant's homes (one in the bedroom and one in the main living area); each HEPA will run for 2 consecutive 7-day sampling sessions. During one of the 7-day sampling sessions, the HEPA filter will run without the internal filter in place (i.e., "placebo" filtration).

Also known as: Living area HEPA: Honeywell, Model 50250, Bedroom HEPA: Honeywell, Model 18155
Indoor Air HEPA Filtration
HEPA Filtration PlaceboDEVICE

for one of the two 7-day sampling sessions, both HEPA filters placed in participants' homes will be run without the actual filter in the housing unit.

Also known as: Living area HEPA: Honeywell, Model 50250, Bedroom HEPA: Honeywell, Model 18155
HEPA Filtration Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • non-smoking household
  • lives within study boundaries and in areas of interest

You may not qualify if:

  • COPD
  • asthma
  • diabetes
  • heart disease
  • hypertension
  • arthritis
  • gum disease
  • occupationally exposed to traffic exposures \&/or woodsmoke
  • if female, pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simon Fraser University

Burnaby, British Columbia, V5A 1S6, Canada

Location

Related Publications (2)

  • Allen RW, Carlsten C, Karlen B, Leckie S, van Eeden S, Vedal S, Wong I, Brauer M. An air filter intervention study of endothelial function among healthy adults in a woodsmoke-impacted community. Am J Respir Crit Care Med. 2011 May 1;183(9):1222-30. doi: 10.1164/rccm.201010-1572OC. Epub 2011 Jan 21.

    PMID: 21257787BACKGROUND

  • Kajbafzadeh M, Brauer M, Karlen B, Carlsten C, van Eeden S, Allen RW. The impacts of traffic-related and woodsmoke particulate matter on measures of cardiovascular health: a HEPA filter intervention study. Occup Environ Med. 2015 Jun;72(6):394-400. doi: 10.1136/oemed-2014-102696. Epub 2015 Apr 20.

    PMID: 25896330DERIVED

MeSH Terms

Conditions

InflammationPathologic Processes

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

  • Ryan Allen, PhD

    Simon Fraser University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 15, 2012

First Posted

April 4, 2012

Study Start

November 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations

CA(1)