BronchiolitisBREATHENCT05615870
Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters
A study testing Winix 5500-2 HEPA filtration units in people with Bronchiolitis, run by IDeA States Pediatric Clinical Trials Network at 17 sites in United States.
Trial summary
This is a multi-center, parallel, double-blind, randomized controlled clinical trial. Children <12 months of age hospitalized with bronchiolitis are randomized 1:1 to receive a 24-week home intervention with filtration units containing HEPA and carbon filters (in the child's sleep space and a common room) to improve… Read more about this study
- Who is it for?
- Ages 1 week to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Winix 5500-2 HEPA filtration units
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 17 sitesUnited States
- Study dates
- 7 Nov 2022to 19 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 week to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age <12 months at hospital admission
- First-time hospitalization for bronchiolitis
- One primary residence (>5 days per week)
- Parent, legal guardian or other legally authorized representative consents to allow their child to participate and agrees to participate in all study activities
- Electricity in the home (required to power the study equipment)
- Wireless internet access or cellular service access in the home*
- English or Spanish-speaking parent or guardian
Who cannot join
- Chronic airway or respiratory conditions requiring home oxygen, mechanical ventilation, or tracheostomy dependence; known immunodeficiency, hemodynamically significant cardiac conditions including those requiring medication or oxygen; cystic fibrosis; neuromuscular disease; eligible for palivizumab (per AAP guidelines87)
- Use of stand-alone home HEPA filtration other than study-related HEPA units in the home
- Household member who smokes (any type), vapes, or uses e-cigarettes
- Intention to move in the next 6 months
- Enrolled or plans to enroll in an interventional clinical trial for treatment of acute bronchiolitis or sequelae of bronchiolitis, unless permission given by the PI
- Another child in the household is enrolled in this study (one child per household can enroll)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
Alaska Native Tribal Health Consortium
Anchorage, Alaska, 99508
University of Vermont Medical Center
Burlington, Vermont, 05401
Prisma Health-Midlands
Columbia, South Carolina, 29203
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, 96826
University of Miss. Medical Center
Jackson, Mississippi, 39216
Kansas University Medical Center
Kansas City, Kansas, 66160
Dartmouth Hospital
Lebanon, New Hampshire, 03756
Arkansas Children's Hospital - Little Rock (ACHRI)
Little Rock, Arkansas, 72202
University of Louisville
Louisville, Kentucky, 40292
University of Montana
Missoula, Montana, 59812
West Virginia University
Morgantown, West Virginia, 26506
Tulane University, Department of Pediatrics
New Orleans, Louisiana, 70112
Children's Hospital OU Medical Center
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Rhode Island Hospital
Providence, Rhode Island, 02903
Avera Research Institute
Sioux Falls, South Dakota, 57108
About this study
This is a multi-center, parallel, double-blind, randomized controlled clinical trial. Children <12 months of age hospitalized with bronchiolitis are randomized 1:1 to receive a 24-week home intervention with filtration units containing HEPA and carbon filters (in the child's sleep space and a common room) to improve indoor air quality (IAQ) or to a control group with filtration units without HEPA and carbon filters. The HEPA intervention units and control units will be used for 24 weeks after pre-intervention IAQ measurements. Children are followed for respiratory outcomes over the pre-intervention and intervention periods.
Read the detailed description
This is a multi-center, parallel, double-blind, randomized controlled clinical trial. Two hundred twenty-eight children <12 months old with their first hospitalization for bronchiolitis will be randomized 1:1 (stratified by site) to receive 24 weeks of home intervention with active HEPA filtration units to improve IAQ or to a control group without a HEPA or carbon filter inside identical-appearing units. Children will be followed for respiratory symptoms during a pre-intervention period of up to two weeks following randomization and during an intervention period of 24 weeks.
This study is designed to reduce barriers to participation for rural participants in that there will be no required study visits to a distant study site, and all study activities and data collection will be conducted remotely. Participants will be identified in hospitals in ISPCTN states, maximizing the chances that rural and medically underserved populations are represented. It is common for rural children with bronchiolitis to be transferred to tertiary care centers in urban/suburban locales, so inclusion of urban hospitals will allow for recruitment of this population.1 It is important for rural children to be represented in a bronchiolitis study in order to increase generalizability. Rural and underserved children have a higher risk of decreased access to medical care for symptoms and illness episodes, and a higher burden of asthma.83,84 These families may have air pollutant exposure profiles distinct from those residing in urban areas. For example, they might experience less exposure to traffic-related pollutants but may have more wood stove use or exposure to agricultural pollutants or wildfires. With its diversity of sites, the ECHO ISPCTN is well-positioned to enroll rural children that might otherwise be excluded.
- Conditions
- Bronchiolitis
- Being tested
- Winix 5500-2 HEPA filtration units
- Keywords
- Children<12 months of age hospitalized with bronchiolitis
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Winix 5500-2 HEPA filtration unitsOther
To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Active Filter) | Active comparator | The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child's sleep space and one will be placed in another common room with both units running continuously on the "high" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production. Receives: Other: Winix 5500-2 HEPA filtration units |
| Control Group (No Filter) | Sham comparator | The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters. Receives: Other: Winix 5500-2 HEPA filtration units |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Caregiver-reported Symptom-free Days (SFDs)
An SFD is defined as a 24-hour period without coughing, wheezing, or trouble breathing
Measured: 24 Weeks
Secondary outcomes (3)
Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints
Caregiver reported number of hospitalizations, emergency department or urgent care visits, other unscheduled medical visits, and the sum of total counts of all metrics for respiratory complaints
Measured: 24 weeks
Total Quality of Life (QOL) Score
QOL score is measured by the Pediatric Quality of Life Inventory TM (PedsQLTM) Infants Scales questionnaire. The scores are reverse-scored and linearly transformed to a 0-100 scale. Higher scores mean a better outcome.
Measured: 24 weeks
Average Particulate Matter (PM2.5) Levels
PM2.5 levels (Particulate Matter ≤ 2.5 micrometers in diameter) are measured by in-home monitors and scaled to unit of micrograms per cubic meter per week. Higher levels mean a worse outcome.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start7 Nov 2022
- Primary completion5 Jul 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies 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
- This is a multi-center, parallel, double-blind, randomized controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- IDeA States Pediatric Clinical Trials Network
- Sponsor type
- Research network
- Collaborators
- University of Vermont Medical Center, University of Montana, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Kelly Cowan, MD, Study chair, University of Vermont Medical CenterErin Semmens, PhD, MPH, Study chair, University of Montana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615870
- Sponsor's protocol ID
- 274137
- Other IDs
- U24OD024957
- Acronym
- BREATHE
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2022
- Last updated
- 2 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will place participant's de-identified data and other limited information, such as race and ethnic group, into one or more centralized database(s). The study team will share this data in compliance with the ISPCTN and NIH data sharing policies
Publications
Cowan K, Semmens EO, Lee JY, Walker ES, Smith PG, Fu L, Singleton R, Cox SM, Faiella J, Chassereau L, Lawrence L, Ying J, Baldner J, Garza M, Annett R, Chervinskiy SK, Snowden J. Bronchiolitis recovery and the use of High Efficiency Particulate Air (HEPA) Filters (The BREATHE Study): study protocol for a multi-center, parallel, double-blind, randomized controlled clinical trial. Trials. 2024 Mar 20;25(1):197. doi: 10.1186/s13063-024-08012-0.
PubMed 38504367
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters
- ClinicalTrials.gov ID
- NCT05615870
- Acronym / sponsor ID
- BREATHE / 274137
- Conditions
- Bronchiolitis
- Keywords
- Children<12 months of age hospitalized with bronchiolitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- IDeA States Pediatric Clinical Trials NetworkResearch network
- Collaborators
- University of Vermont Medical Center, University of Montana, National Institutes of Health (NIH)
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Posted 2 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, parallel, double-blind, randomized controlled clinical trial. Children <12 months of age hospitalized with bronchiolitis are randomized 1:1 to receive a 24-week home intervention with filtration units containing HEPA and carbon filters (in the child's sleep space and a common room) to improve indoor air quality (IAQ) or to a control group with filtration units without HEPA and carbon filters. The HEPA intervention units and control units will be used for 24 weeks after pre-intervention IAQ measurements. Children are followed for respiratory outcomes over the pre-intervention and intervention periods.
Detailed description
This is a multi-center, parallel, double-blind, randomized controlled clinical trial. Two hundred twenty-eight children <12 months old with their first hospitalization for bronchiolitis will be randomized 1:1 (stratified by site) to receive 24 weeks of home intervention with active HEPA filtration units to improve IAQ or to a control group without a HEPA or carbon filter inside identical-appearing units. Children will be followed for respiratory symptoms during a pre-intervention period of up to two weeks following randomization and during an intervention period of 24 weeks.
This study is designed to reduce barriers to participation for rural participants in that there will be no required study visits to a distant study site, and all study activities and data collection will be conducted remotely. Participants will be identified in hospitals in ISPCTN states, maximizing the chances that rural and medically underserved populations are represented. It is common for rural children with bronchiolitis to be transferred to tertiary care centers in urban/suburban locales, so inclusion of urban hospitals will allow for recruitment of this population.1 It is important for rural children to be represented in a bronchiolitis study in order to increase generalizability. Rural and underserved children have a higher risk of decreased access to medical care for symptoms and illness episodes, and a higher burden of asthma.83,84 These families may have air pollutant exposure profiles distinct from those residing in urban areas. For example, they might experience less exposure to traffic-related pollutants but may have more wood stove use or exposure to agricultural pollutants or wildfires. With its diversity of sites, the ECHO ISPCTN is well-positioned to enroll rural children that might otherwise be excluded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a multi-center, parallel, double-blind, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Active Filter) | Active comparator | Other: Winix 5500-2 HEPA filtration unitsThe intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child's sleep space and one will be placed in another common room with both units running continuously on the "high" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production. |
| Control Group (No Filter) | Sham comparator | Other: Winix 5500-2 HEPA filtration unitsThe control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters. |
Who may qualify
- Ages
- 1 week to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age <12 months at hospital admission
- First-time hospitalization for bronchiolitis
- One primary residence (>5 days per week)
- Parent, legal guardian or other legally authorized representative consents to allow their child to participate and agrees to participate in all study activities
- Electricity in the home (required to power the study equipment)
Key exclusion criteria (6 listed)
- Chronic airway or respiratory conditions requiring home oxygen, mechanical ventilation, or tracheostomy dependence; known immunodeficiency, hemodynamically significant cardiac conditions including those requiring medication or oxygen; cystic fibrosis; neuromuscular disease; eligible for palivizumab (per AAP guidelines87)
- Use of stand-alone home HEPA filtration other than study-related HEPA units in the home
- Household member who smokes (any type), vapes, or uses e-cigarettes
- Intention to move in the next 6 months
- Enrolled or plans to enroll in an interventional clinical trial for treatment of acute bronchiolitis or sequelae of bronchiolitis, unless permission given by the PI
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 |
|---|---|---|
| Winix 5500-2 HEPA filtration unitsTo determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit. | Other | Control Group (No Filter), Intervention Group (Active Filter) |
Primary outcome
Number of Caregiver-reported Symptom-free Days (SFDs)
Time frame: 24 Weeks
An SFD is defined as a 24-hour period without coughing, wheezing, or trouble breathing
3 secondary outcomes
Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints
Time frame: 24 weeks
Total Quality of Life (QOL) Score
Time frame: 24 weeks
Average Particulate Matter (PM2.5) Levels
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38504367Cowan K, Semmens EO, Lee JY, Walker ES, Smith PG, Fu L, Singleton R, Cox SM, Faiella J, Chassereau L, Lawrence L, Ying J, Baldner J, Garza M, Annett R, Chervinskiy SK, Snowden J. Bronchiolitis recovery and the use of High Efficiency Particulate Air (HEPA) Filters (The BREATHE Study): study protocol for a multi-center, parallel, double-blind, randomized controlled clinical trial. Trials. 2024 Mar 20;25(1):197. doi: 10.1186/s13063-024-08012-0.
- Individual participant dataSharing planned: Yes. The study team will place participant's de-identified data and other limited information, such as race and ethnic group, into one or more centralized database(s). The study team will share this data in compliance with the ISPCTN and NIH data sharing policies
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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.
Kelly Cowan, MD study chair
University of Vermont Medical Center
Erin Semmens, PhD, MPH study chair
University of Montana
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Winix 5500-2 HEPA filtration units in people with Bronchiolitis, run by IDeA States Pediatric Clinical Trials Network at 17 sites 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 7 inclusion and 6 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 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
Yes. Results are posted in the registry (first posted 2 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Caregiver-reported Symptom-free Days (SFDs) (time frame: 24 Weeks). 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 NCT05615870, which also lists 1 linked publication.
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 2 Oct 2025.