Respiratory Tract DiseasesASPIREHealthNCT05944770
ASPIRE Health Tulare County
A study testing DIY portable air cleaner with a highly effective filter in people with Respiratory Tract Diseases and Cardiovascular Diseases, run by Environmental Protection Agency (EPA) at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Diseases, Cardiovascular Diseases
- What is being tested?
- DIY portable air cleaner with a highly effective filter
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2023to 31 Oct 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Central California Environmental Justice Network
Fresno, California, 93727
About this study
Official title: 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?
Read more
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.
Read the 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.
- Being tested
- DIY portable air cleaner with a highly effective filter, DIY portable air cleaner with sham filtration
- Keywords
- air pollution, wildfire smoke, wildland fire smoke, air filtration, indoor air quality
- Medical subject headings
- Respiratory Tract Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIY portable air cleaner with a highly effective filterOther
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.
DIY portable air cleaner with sham filtrationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | 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. Receives: Other: DIY portable air cleaner with a highly effective filter |
| Control arm | Sham comparator | 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. Receives: Other: DIY portable air cleaner with sham filtration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in change in concentrations of biomarkers of inflammation between treatment and control groups
Markers of inflammation include C-reactive protein obtained from fingerstick blood samples
Measured: Measured at baseline (pre-intervention) and at two timepoints, at least 3 days apart, during the portable air cleaner usage period (intervention)
Secondary outcomes (2)
Difference in change in concentrations of biomarkers of inflammation between treatment and control groups
Markers of inflammation obtained from nasal epithelial lining fluid analyses
Measured: Measured at Baseline and at two timepoints, at least 3 days apart, during the portable air cleaner usage period (intervention)
Symptom data
Symptom/clinical data obtained from questionnaires
Measured: At baseline and at one timepoint during portable air cleaner use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start29 Jul 2023
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract DiseasesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to the intervention or control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Environmental Protection Agency (EPA)
- Sponsor type
- US federal agency
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Ann Chelminski, Environmental Protection Agency (EPA)
- Investigators
- Ann N Chelminski, MD, MPH, Principal investigator, Environmental Protection Agency (EPA)Nayamin Martinez, MPH, Principal investigator, Central California Environmental Justice Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944770
- Sponsor's protocol ID
- 23-0965
- Acronym
- ASPIREHealth
- Status last verified
- Oct 2023
- First submitted
- 31 May 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 292728272. 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.
PubMed 331217634. 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.
PubMed 35580674Holder 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.
PubMed 36437679Batterman 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.
PubMed 22145709
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASPIRE (Advancing Science Partnerships for Indoor Reductions of Smoke Exposures)-Health Tulare County
- ClinicalTrials.gov ID
- NCT05944770
- Acronym / sponsor ID
- ASPIREHealth / 23-0965
- Keywords
- air pollution, wildfire smoke, wildland fire smoke, air filtration, indoor air quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Environmental Protection Agency (EPA)US federal agency
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 29 Jul 2023 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 13 Jul 2023 (actual)
- 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to the intervention or control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Other: DIY portable air cleaner with a highly effective filterSubjects 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. |
| Control arm | Sham comparator | Other: DIY portable air cleaner with sham filtrationSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| DIY portable air cleaner with a highly effective filterA 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. | Other | Intervention arm |
| DIY portable air cleaner with sham filtrationA 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. | Other | Control arm |
Primary outcome
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
2 secondary outcomes
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)
Symptom data
Time frame: At baseline and at one timepoint during portable air cleaner use
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Background: PubMed 29272827Cascio 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.
- Background2. 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.
- Background: PubMed 33121763Cheek 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.
- Background4. Program CTAQ. Box fan filter, a DIY users guide. 2022; https://www.cct-enr.com/box-fan-filter. Accessed September 16, 2022.
- Background5. Puget Sound Clean Air Agency. DIY Air Filter. https://pscleanair.gov/525/DIY-Air-Filter. Accessed September 16, 2022.
- Background: PubMed 35580674Srikrishna 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.
- Background: PubMed 36437679Holder 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.
- Background: PubMed 22145709Batterman 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.
- Create a clean room to protect indoor air quality during a wildfireLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ann N Chelminski, MD, MPH principal investigator
Environmental Protection Agency (EPA)
Nayamin Martinez, MPH principal investigator
Central California Environmental Justice Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIY portable air cleaner with a highly effective filter in people with Respiratory Tract Diseases and Cardiovascular Diseases, run by Environmental Protection Agency (EPA) at 1 site in United States.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Oct 2023. 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 United States. 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.
Are results available for this study?
Results are not available in the source record.
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 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)). 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 NCT05944770, which also lists 8 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 27 Oct 2023.