NCT03187704

Brief Summary

The study is a blinded cross over test of in-home air filtration. Participants will have a window unit air filter (HEPA) installed that will filter for 3 weeks and do sham filtration for another 3 weeks. During the time that the filter is installed in the home a machine that measures particulate air pollution of the type that the filter is designed to remove will be installed. A survey will be administered, blood samples taken and blood pressure measured immediately prior to starting the filter, at 3 weeks when the filtration is changed from sham to real filtration or visa versa and at the end of the second three week period. All participants will be recruited from the Boston Puerto Rican Health Study cohort.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

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

May 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

2.7 years

First QC Date

June 13, 2017

Last Update Submit

June 19, 2017

Conditions

Keywords

air filtration, HEPA, In-home,

Outcome Measures

Primary Outcomes (1)

  • Blood biomarkers

    hsCRP, IL-6, TNFRII

    6 weeks

Study Arms (2)

filtration

ACTIVE COMPARATOR

Air filtration in homes

Other: HEPA air filtration

no filtration

SHAM COMPARATOR

Sham air filtration

Other: HEPA air filtration

Interventions

Air filters were placed in participant homes

filtrationno filtration

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant in the larger parent cohort of the BPRHS

You may not qualify if:

  • None since already enrolled in the cohort

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts University School of Medicine

Boston, Massachusetts, 02111, United States

Location

Related Publications (5)

  • Padro-Martinez LT, Owusu E, Reisner E, Zamore W, Simon MC, Mwamburi M, Brown CA, Chung M, Brugge D, Durant JL. A Randomized Cross-over Air Filtration Intervention Trial for Reducing Cardiovascular Health Risks in Residents of Public Housing near a Highway. Int J Environ Res Public Health. 2015 Jul 10;12(7):7814-38. doi: 10.3390/ijerph120707814.

    PMID: 26184257BACKGROUND
  • Bhangar S, Mullen NA, Hering SV, Kreisberg NM, Nazaroff WW. Ultrafine particle concentrations and exposures in seven residences in northern California. Indoor Air. 2011 Apr;21(2):132-44. doi: 10.1111/j.1600-0668.2010.00689.x. Epub 2010 Oct 28.

    PMID: 21029183BACKGROUND
  • Rim D, Wallace L, Persily A. Infiltration of outdoor ultrafine particles into a test house. Environ Sci Technol. 2010 Aug 1;44(15):5908-13. doi: 10.1021/es101202a.

    PMID: 20666560BACKGROUND
  • Wallace L, Kindzierski W, Kearney J, MacNeill M, Heroux ME, Wheeler AJ. Fine and ultrafine particle decay rates in multiple homes. Environ Sci Technol. 2013 Nov 19;47(22):12929-37. doi: 10.1021/es402580t. Epub 2013 Nov 6.

    PMID: 24143863BACKGROUND
  • Beko G, Weschler CJ, Wierzbicka A, Karottki DG, Toftum J, Loft S, Clausen G. Ultrafine particles: exposure and source apportionment in 56 Danish homes. Environ Sci Technol. 2013 Sep 17;47(18):10240-8. doi: 10.1021/es402429h. Epub 2013 Sep 4.

    PMID: 23957328BACKGROUND

Study Officials

  • Doug Brugge, PhD

    Tufts University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants were blinded as to filtration and no filtration. The lab was blinded as to which samples were from filtration or no filtration periods.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Randomized cross-over
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 15, 2017

Study Start

May 1, 2012

Primary Completion

December 31, 2014

Study Completion

December 31, 2014

Last Updated

June 20, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

We do not plan to share individual participant data

Locations