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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01256957
Other study ID # 869329
Secondary ID
Status Completed
Phase N/A
First received December 8, 2010
Last updated December 1, 2016
Start date November 2008
Est. completion date April 2009

Study information

Verified date December 2010
Source Simon Fraser University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

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 woodsmoke air pollution indoors and to improve subclinical indicators of microvascular function, systemic inflammation, and oxidative stress among healthy adult participants.


Description:

The investigators will use portable HEPA filters in a single-blind randomized crossover design. Each participant's home will be monitored for two consecutive seven-day periods, during which time two HEPA units (one in the bedroom and one in the main living room) will be operated indoors. During one 7-day period the HEPA filters will be operated normally, and during the other period the HEPA unit will be operated without the internal filter in place (i.e., "placebo filtration"), thus blinding participants to the filters' status. The order of filtration or non-filtration will be random. At the end of each 7-day period microvascular function will be assessed, blood will be collected for assessment of systemic inflammatory markers, and urine will be collected for assessment of oxidative stress markers.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

- 19 years or older

- Non-smoking household

- Lives in study region (Smithers or Telkwa British Columbia)

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Intervention

Device:
HEPA filter


Locations

Country Name City State
Canada Simon Fraser University Burnaby British Columbia

Sponsors (4)

Lead Sponsor Collaborator
Simon Fraser University Health Canada, Ministry of Environment, British Columbia, University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reactive hyperemia index After 1 week of air filtration No
Secondary C-reactive protein After 1 week of filtration No
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