Endothelial DysfunctionPhase 2CLEARNCT01570062
Cardiovascular Effects of Aerosols in Residences Study
A Phase 2 study testing HEPA Filter in people with Endothelial Dysfunction and Systemic Inflammation, run by Simon Fraser University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction, Systemic Inflammation
- What is being tested?
- HEPA Filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Aug 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19 years or older
- non-smoking household
- lives within study boundaries and in areas of interest
Who cannot join
- COPD
- asthma
- diabetes
- heart disease
- hypertension
- arthritis
Show all 9Show fewer
- gum disease
- occupationally exposed to traffic exposures \&/or woodsmoke
- if female, pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subclinical Cardiovascular Health Benefits of Interventions to Reduce Exposure to Combustion-Derived Particulate Air Pollution
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.
Read the detailed description
To address knowledge gaps about health risks of specific pollution sources and to provide new evidence on the health benefits of air pollution interventions, the objectives of this study are: 1) quantify the relationship between low-level exposures to combustion-derived PM air pollution and subclinical indicators of cardiovascular disease risk; and 2) compare the relative impact of HEPA filtration for two major PM sources (traffic and residential wood combustion) on these indicators.
The use of HEPA filters may help to mitigate cardiovascular risks factors caused by combustion-derived air pollution (CDAP), (specifically woodstove and traffic emissions). We hypothesize that HEPA filter use and improved woodstove technology will help decrease indoor occurrences of CDAP. This project will help address knowledge gaps in CDAP-related health risks and benefits of interventions. Specific objectives include establishing a relationship between exposure to CDAP and biomarkers of cardiovascular risk and evaluating the impact of HEPA filter use towards improved indoor air quality and health indicators.
- Conditions
- Endothelial Dysfunction, Systemic Inflammation
- Being tested
- HEPA Filter, HEPA Filtration Placebo
- Keywords
- Inflammation, Pathologic Processes
- Medical subject headings
- Inflammation, Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEPA FilterDevice
Also called Living area HEPA: Honeywell, Model 50250, Bedroom HEPA: Honeywell, Model 18155
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).
HEPA Filtration PlaceboDevice
Also called Living area HEPA: Honeywell, Model 50250, Bedroom HEPA: Honeywell, Model 18155
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: HEPA Filtration Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: after 1 week of filtration
Secondary outcomes (1)
Difference in C-Reactive Protein after HEPA Filtration
Participants CRP is measured after 1 week of HEPA filtration and after 1 week of non-HEPA filtration (placebo filtration).
Measured: after 1 week of filtration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon Fraser University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Allen, Simon Fraser University
- Investigators
- Ryan Allen, PhD, Principal investigator, Simon Fraser University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570062
- Sponsor's protocol ID
- Allen,R-MOP111042
- Acronym
- CLEAR
- Status last verified
- Apr 2014
- First submitted
- 15 Mar 2012
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21257787Kajbafzadeh 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.
PubMed 25896330
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclinical Cardiovascular Health Benefits of Interventions to Reduce Exposure to Combustion-Derived Particulate Air Pollution
- ClinicalTrials.gov ID
- NCT01570062
- Acronym / sponsor ID
- CLEAR / Allen,R-MOP111042
- Conditions
- Endothelial Dysfunction, Systemic Inflammation
- Keywords
- Inflammation, Pathologic Processes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Simon Fraser UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To address knowledge gaps about health risks of specific pollution sources and to provide new evidence on the health benefits of air pollution interventions, the objectives of this study are: 1) quantify the relationship between low-level exposures to combustion-derived PM air pollution and subclinical indicators of cardiovascular disease risk; and 2) compare the relative impact of HEPA filtration for two major PM sources (traffic and residential wood combustion) on these indicators.
The use of HEPA filters may help to mitigate cardiovascular risks factors caused by combustion-derived air pollution (CDAP), (specifically woodstove and traffic emissions). We hypothesize that HEPA filter use and improved woodstove technology will help decrease indoor occurrences of CDAP. This project will help address knowledge gaps in CDAP-related health risks and benefits of interventions. Specific objectives include establishing a relationship between exposure to CDAP and biomarkers of cardiovascular risk and evaluating the impact of HEPA filter use towards improved indoor air quality and health indicators.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indoor Air HEPA Filtration | Active comparator | Device: HEPA FilterHEPA 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. |
| HEPA Filtration Placebo | Placebo comparator | Device: HEPA Filtration PlaceboFor one of two 7-day sampling sessions, HEPA filters placed in participants' homes will be run without an actual filter in the housing unit. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 years or older
- non-smoking household
- lives within study boundaries and in areas of interest
Key exclusion criteria (9 listed)
- COPD
- asthma
- diabetes
- heart disease
- hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEPA FilterAlso: Living area HEPA: Honeywell, Model 50250, Bedroom HEPA: Honeywell, Model 18155Two 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). | Device | Indoor Air HEPA Filtration |
| HEPA Filtration PlaceboAlso: Living area HEPA: Honeywell, Model 50250, Bedroom HEPA: Honeywell, Model 18155for 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. | Device | HEPA Filtration Placebo |
Primary outcome
Difference in reactive hyperemia measurement after HEPA filtration
Time frame: after 1 week of filtration
Participants endothelial function are tested after 1 week of HEPA filtration and after 1 week of non-HEPA filtration (placebo filtration).
1 secondary outcome
Difference in C-Reactive Protein after HEPA Filtration
Time frame: after 1 week of filtration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
- Background: PubMed 21257787Allen 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.
- Derived from this study: PubMed 25896330Kajbafzadeh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Allen, PhD principal investigator
Simon Fraser University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HEPA Filter in people with Endothelial Dysfunction and Systemic Inflammation, run by Simon Fraser University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in reactive hyperemia measurement after HEPA filtration (time frame: after 1 week of filtration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01570062, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.