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Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters
NA trial testing Winix 5500-2 HEPA filtration units in Bronchiolitis in 230 participants. Completed in 19 July 2024.
| Lead sponsor | IDeA States Pediatric Clinical Trials Network |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 230 |
| Start date | 7 November 2022 |
| Primary completion | 5 July 2024 |
| Estimated completion | 19 July 2024 |
| Sites | 17 locations across United States |
IDeA States Pediatric Clinical Trials Network
Adults 1 Week to 12 Months, any sex, with Bronchiolitis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
An SFD is defined as a 24-hour period without coughing, wheezing, or trouble breathing
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group (Active Filter) | 118.01 | ± 42.66 |
| Control Group (No Filter) | 112.60 | ± 46.33 |
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
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group (Active Filter) | 0.28 | ± 0.91 |
| Control Group (No Filter) | 0.16 | ± 0.60 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group (Active Filter) | 0.68 | ± 1.25 |
| Control Group (No Filter) | 0.68 | ± 1.32 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group (Active Filter) | 1.11 | ± 1.65 |
| Control Group (No Filter) | 1.48 | ± 1.99 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group (Active Filter) | 2.06 | ± 2.83 |
| Control Group (No Filter) | 2.31 | ± 2.84 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group (Active Filter) | 81.34 | ± 9.99 |
| Control Group (No Filter) | 82.13 | ± 10.68 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group (Active Filter) | 10.70 | ± 15.91 |
| Control Group (No Filter) | 15.27 | ± 16.86 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group (Active Filter) | 11.08 | ± 18.77 |
| Control Group (No Filter) | 21.45 | ± 33.14 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group (Active Filter) | 10.66 | ± 15.53 |
| Control Group (No Filter) | 17.96 | ± 21.35 |
Time frame: From November 24, 2022, to May 22, 2024 (1 year, 5.9 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Intervention Group (Active… | Control Group (No Filter) |
|---|---|---|---|
| Other - Bronchiolitis | Infections and infestations | — | — |
| Other - bronchiolitis, hospitalization for hypoxia & increased work of breathing, and respiratory di | Respiratory, thoracic and mediastinal disorders | — | — |
| Other - Respiratory Distress, Reactive airway disease with wheezing, Hypoxemia and nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Medical or emergency department/urgent care visit for respiratory complaint | Respiratory, thoracic and mediastinal disorders | — | — |
| Trouble breathing | Respiratory, thoracic and mediastinal disorders | — | — |
| Wheeze | Respiratory, thoracic and mediastinal disorders | — | — |
| Other - seizure like activity | Nervous system disorders | — | — |
| VSD repair surgery | Surgical and medical procedures | — | — |
| Other - Patient had bilateral ear tubes placed | Injury, poisoning and procedural complications | — | — |
| Other - Hospitalization due to failure to thrive | Metabolism and nutrition disorders | — | — |
| Reaction | System | Intervention Group (Active… | Control Group (No Filter) |
|---|---|---|---|
| Other - Rhinitis, Coughing, Wheezing | Respiratory, thoracic and mediastinal disorders | — | — |
| Other - Subglottic stenosis requiring micro laryngoscopy and bronchoscopy / Reactive Airway Disease | Respiratory, thoracic and mediastinal disorders | — | — |
| Medical or emergency department/urgent care visit for respiratory complaint | Respiratory, thoracic and mediastinal disorders | — | — |
| Other- Viral induced asthma | Immune system disorders | — | — |
| Other - Seizure | Nervous system disorders | — | — |
| Other - Cough | Infections and infestations | — | — |
| Other - Constipation issues that required emergency room visit | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Other - Bronchiolitis, Other - bronchiolitis, hospitalization for hypoxia & increased work of breathing, and respiratory di, Other - Respiratory Distress, Reactive airway disease with wheezing, Hypoxemia and nasal congestion, Medical or emergency department/urgent care visit for respiratory complaint, Trouble breathing, Wheeze, Other - seizure like activity, VSD repair surgery.
Data from ClinicalTrials.gov NCT05615870 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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