- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05944770
ASPIRE Health Tulare County (ASPIREHealth)
ASPIRE (Advancing Science Partnerships for Indoor Reductions of Smoke Exposures)-Health Tulare County
The goal of this clinical trial is to compare indoor air quality and health in people exposed to air pollution, including possible exposure to wildfire smoke. The study will test the effect of using a do-it-yourself (DIY) air cleaner when air pollution is present to answer the following questions:
- Do health outcomes differ between participants who use a DIY PAC and those who use a sham air cleaner?
- How effective is the DIY air cleaner in reducing indoor concentrations of fine particles (PM2.5), and volatile organic compounds found in wildfire smoke? OR How effective is the DIY air cleaner in reducing indoor concentrations of fine and coarse particles (i.e., PM 10)?
- What are barriers to use of a DIY air cleaner and what factors facilitate its use?
Participants will be asked to do the following:
- Participate in 5 home visits from study staff between July - October 2023
- Have an air quality sensor placed in the participant's bedroom for the whole study period
- Have a small sensor attached to the main door of the participant's house to record when the door is open or closed (important for air quality inside)
- Allow researchers to take air and dust samples in the participant's bedroom
- Run a DIY air cleaner in the participant's bedroom for at least 6 nights while the participant sleeps
- Complete 2 interviews
- Allow study staff to collect 3 fingerstick blood samples
- Allow study staff to collect 3 samples of fluid from inside the nose
- Use the study air cleaner in the participant's bedroom during the study period
The investigators will measure air quality in participating homes and measure health outcomes for participants. The investigators will compare outcomes of participants who use a DIY air cleaner with filters that work well to those of participants who use a DIY air cleaner with a placebo filter (one that does not work well to remove the air pollutants of concern). The goal of the study is to see if using the effective air cleaner leads to better health outcomes and indoor air quality.
Study Overview
Status
Detailed Description
Background and rationale: The motivation for this research is that wildfires have been increasing in frequency and severity in recent years. Wildfire smoke is associated with numerous adverse health outcomes. Public health guidance during wildfire events has included recommendations to stay indoors, close doors and windows, and use portable air cleaners (PACs) to clean the smoke that infiltrates the indoor environment. Studies support the effectiveness of PACs in reducing indoor fine particulate matter, (PM2.5=fine particles 2.5 micrometers in diameter or smaller), one of the main components of concern in wildfire smoke.
Evidence of whether PAC use is associated with health benefits is mixed. In addition, commercially-available PACs can be expensive and hard to access. An affordable alternative that gained attention during the COVID-19 pandemic is a Do-It-Yourself (DIY) PAC, made from a box fan and high efficiency filter(s). Laboratory studies have shown DIY PACs to have excellent clean air delivery rates (CADR, a measure of effectiveness) with respect to fine particulate matter. However, their evidence in real-world settings is limited. Researchers have acknowledged that behaviors, such as turning on/off the fans, could have major impacts on efficacy.
The current study aims to examine the effect of PACs on indoor air quality and health during wildfire smoke exposure. The investigators will conduct this research in an agricultural community in central California that has experienced wildfire smoke exposure and routinely experiences dust. According to local partners, most residents of this county do not already own PACs. One risk of planning a Randomized Control Trial (RCT) of wildfire smoke exposure is that wildfire smoke will not occur. For this reason, the investigators selected a community with historically elevated levels of particle pollution (PM2.5, PM10, dust) in the fall and winter months as the study site. If wildfire smoke exposure does not occur during the study period, the efficacy of the DIY PACs on indoor air quality and health will be tested during periods of dust/high particle pollution exposure (anticipated October 2023).
Up to 120 recruited and consented study participants will be randomly divided into 2 groups. One group will use an effective DIY air cleaner (intervention); the other group will use a sham DIY air cleaner (control). All groups will have the same basic exposure to ambient air pollution.
Qualified participants will agree to have air quality sensors and door monitors placed in their home (bedroom and main exterior door). Air quality will be measured continuously during the study period. Other study activities will occur intermittently, during 5 visits by study staff to the participant's home. These activities will include completing 2 symptom and demographic questionnaires, collecting air and dust samples from inside the homes and collecting biological samples at 3 visits (capillary blood (by fingerstick) and nasal epithelial lining fluid). Blood and nasal fluid collected will be assessed for markers of inflammation and immune system activation. The investigators hypothesize that subjects in the intervention group will have reduced concentrations of measured air pollutants in their indoor air samples and lower levels of markers of inflammation compared to those in the control group. The investigators further hypothesize that symptoms, particularly related to respiratory inflammation, will differ between intervention (air filtration) and control (sham filtration) groups. Baseline measurements and post-intervention period measurements will be compared for intra-individual change and differences between study groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ann N Chelminski, MD, MPH
- Phone Number: 919-966-0662
- Email: chelminski.ann@epa.gov
Study Contact Backup
- Name: Mallory W Turner, PhD
- Phone Number: 919-966-7550
- Email: turner.mallory@epa.gov
Study Locations
-
-
California
-
Fresno, California, United States, 93727
- Central California Environmental Justice Network
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years or older
- Has access to telephone and/or the internet for study communication
- Is a resident of Tulare County, California
- Is proficient in English or Spanish for study communication
Exclusion Criteria:
- Anyone in the household smokes (tobacco, vape, or other) inside the home
- Plans to move before November 2023
- Regularly travels or sleeps away from home (e.g., once a week or more)
- Already owns and uses a portable air cleaner
- Lives in a multi-unit home with a shared central HVAC system
- Has a bleeding disorder, such as hemophilia (taking a blood thinning medication does not exclude)
- Takes any of the following anti-inflammatory medications regularly: abatacept (Orencia), adalimumab(Humira), anakinra (Kineret), anifrolumab (Saphnelo), apremilast (Otezla), azathioprine (Imuran),certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi Aria), hydroxychloroquine(Plaquenil), infliximab (Remicade), ixekizumab (Taltz), leflunomide (Arava), methotrexate(Rheumatrex, Trexall), prednisone (Deltasone), sulfasalazine (Azulfidine), rituximab (Rituxan,MabThera), sarilumab (Kevzara), tocilizumab (Actemra)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention arm
Subjects in the treatment arm will use a DIY portable air cleaner made by attaching a highly effective furnace filter (MERV 13) and carbon absorbent to a box fan.
|
A portable air filtration device that can be homemade ("DIY"), constructed by attaching a highly effective air filter (MERV13 rating or higher) to a 20 inch box fan to filter air pollutants including particulate matter of size 2.5 micrometers diameter or greater.
|
Sham Comparator: Control arm
Subjects in the control arm will use a DIY portable air cleaner with a sham filter.
All subjects will receive education on air quality, wildfire smoke, and health.
|
A portable air filtration device that can be homemade ("DIY") by attaching an air filter to a 20 inch box fan.
The portable air cleaner with sham filtration with have a filter that is not effective for filtration of fine particulate matter, including that in wildfire smoke.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in change in concentrations of biomarkers of inflammation between treatment and control groups
Time Frame: Measured at baseline (pre-intervention) and at two timepoints, at least 3 days apart, during the portable air cleaner usage period (intervention)
|
Markers of inflammation include C-reactive protein obtained from fingerstick blood samples
|
Measured at baseline (pre-intervention) and at two timepoints, at least 3 days apart, during the portable air cleaner usage period (intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in change in concentrations of biomarkers of inflammation between treatment and control groups
Time Frame: Measured at Baseline and at two timepoints, at least 3 days apart, during the portable air cleaner usage period (intervention)
|
Markers of inflammation obtained from nasal epithelial lining fluid analyses
|
Measured at Baseline and at two timepoints, at least 3 days apart, during the portable air cleaner usage period (intervention)
|
Symptom data
Time Frame: At baseline and at one timepoint during portable air cleaner use
|
Symptom/clinical data obtained from questionnaires
|
At baseline and at one timepoint during portable air cleaner use
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
air quality measurements
Time Frame: Continuous measurement lasting up to 15 weeks
|
Concentrations of PM2.5, PM10 and volatile organic compounds in air inside participants' homes
|
Continuous measurement lasting up to 15 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ann N Chelminski, MD, MPH, Environmental Protection Agency (EPA)
- Principal Investigator: Nayamin Martinez, MPH, Central California Environmental Justice Network
Publications and helpful links
General Publications
- Cascio WE. Wildland fire smoke and human health. Sci Total Environ. 2018 May 15;624:586-595. doi: 10.1016/j.scitotenv.2017.12.086. Epub 2017 Dec 27.
- 2. U.S. Environmental Protection Agency. Create a Clean Room to Protect Indoor Air Quality During a Wildfire. 2022; https://www.epa.gov/indoor-air-quality-iaq/create-clean-room-protect-indoor-air-quality-during-wildfire. Accessed September 30, 2022.
- Cheek E, Guercio V, Shrubsole C, Dimitroulopoulou S. Portable air purification: Review of impacts on indoor air quality and health. Sci Total Environ. 2021 Apr 20;766:142585. doi: 10.1016/j.scitotenv.2020.142585. Epub 2020 Sep 30.
- 4. Program CTAQ. Box fan filter, a DIY users guide. 2022; https://www.cct-enr.com/box-fan-filter. Accessed September 16, 2022.
- 5. Puget Sound Clean Air Agency. DIY Air Filter. https://pscleanair.gov/525/DIY-Air-Filter. Accessed September 16, 2022.
- Srikrishna D. Can 10x cheaper, lower-efficiency particulate air filters and box fans complement High-Efficiency Particulate Air (HEPA) purifiers to help control the COVID-19 pandemic? Sci Total Environ. 2022 Sep 10;838(Pt 1):155884. doi: 10.1016/j.scitotenv.2022.155884. Epub 2022 May 14.
- Holder AL, Halliday HS, Virtaranta L. Impact of do-it-yourself air cleaner design on the reduction of simulated wildfire smoke in a controlled chamber environment. Indoor Air. 2022 Nov;32(11):e13163. doi: 10.1111/ina.13163.
- Batterman S, Du L, Mentz G, Mukherjee B, Parker E, Godwin C, Chin JY, O'Toole A, Robins T, Rowe Z, Lewis T. Particulate matter concentrations in residences: an intervention study evaluating stand-alone filters and air conditioners. Indoor Air. 2012 Jun;22(3):235-52. doi: 10.1111/j.1600-0668.2011.00761.x. Epub 2012 Feb 4.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-0965
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Diseases
-
Medical College of WisconsinRecruitingCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
VA Office of Research and DevelopmentNot yet recruitingCardiovascular DiseaseUnited States
-
Baptist Health South FloridaUniversity of California, Los Angeles; Quest Diagnostics-Nichols InsituteActive, not recruitingCardiovascular DiseaseUnited States
-
Laval UniversityActive, not recruitingCardiovascular DiseaseCanada
-
Penn State UniversityCalifornia Healthcare InstituteCompleted
Clinical Trials on DIY portable air cleaner with a highly effective filter
-
Wayne State UniversityNot yet recruitingMild Hypertension | Air Pollution Exposure
-
Henry Ford Health SystemWayne State UniversityRecruiting
-
Barcelona Institute for Global HealthRecercaixa; Centre de Recerca per a l'Educació Científica i Matemàtica (CRECIM) and other collaboratorsCompletedRisk Behavior | Attention Impaired | Risk-Taking | Social Preferences | Decision Making | AttentionSpain
-
I.M. Sechenov First Moscow State Medical UniversityEnrolling by invitationCOVID-19 | Quality of Life | Oxygen Consumption | Diastolic Dysfunction | Endothelial Function | Exercise ToleranceRussian Federation