Home Air Purification for Eosinophilic COPD
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|ClinicalTrials.gov Identifier: NCT04252235|
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : July 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|COPD Eosinophilia||Device: Air purifier Device: Sham air purifier||Not Applicable|
Chronic obstructive pulmonary disease (COPD) is the third most common cause of death in the United States, and is exacerbated by exposure to air pollution. Knowledge about whether air purification affects the health of those with eosinophilic COPD (approximately 40% of all COPD patients seeking care), who generally have more active airway inflammation. If found to be beneficial, home air purification may offer a non-pharmacologic intervention for a large proportion of people with this common and serious disease.
This study will evaluate whether home air purification affects lung function, respiratory symptoms, nasal biomarkers (inflammatory proteins and metals) among people with eosinophilic COPD. Participants will be randomized to receive real or sham air purifier in the bedroom and living room for 12 months. The intervention group will receive two high efficiency particulate air (HEPA) air purifiers, while the control group will receive two sham air purifiers that look and sound the same as real HEPA air purifiers.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomized to receive real or sham HEPA filters in the bedroom and living room for a total of 12 months.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Sham air purifiers will be indistinguishable from real air purifiers. Only the research assistant installing the purifiers and the data coordinating center will have knowledge of assignment to real or sham purifiers.|
|Official Title:||A Randomized Controlled Trial of Home Air Purification for Eosinophilic COPD|
|Estimated Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||June 2025|
Sham Comparator: Sham air purifier
Participants will receive a sham air purifier that will be installed in the bedroom and living room. These purifiers will make a noise, but will not filter the air.
Device: Sham air purifier
The intervention is the placement of sham HEPA air purifiers in the bedroom and living room. These purifiers look identical to real HEPA air purifiers, but do not filter the air.
Experimental: True air purifier
Participants will receive a HEPA air purifier in the bedroom and living room.
Device: Air purifier
The intervention is the placement of active HEPA air purifiers in the bedroom and living room of the true air purifier arm. These air purifiers have been shown to reduce levels of particles in the home.
- Change in forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months] ]FEV1 is the volume of air exhaled in the first second of a forced exhalation maneuver. Lower volumes indicate worse lung function.
- Change in health status (also called health-related quality of life) by St. George Respiratory Questionnaire [ Time Frame: Baseline [3 months before intervention and day of intervention] and post-intervention [6 months and 12 months] ]The St. George's Respiratory Questionnaire is scored from 0 to 100. Higher scores indicate more health impairment.
- Change in respiratory symptoms [ Time Frame: Monthly for 3 months preintervention and 12 months post-intervention ]The Breathlessness, Cough and Sputum Scale measures the severity of respiratory symptoms in COPD. The total score ranges from 0 to 12, with higher scores indicating greater symptom severity.
- Change in functional capacity by 6 minute walk test [ Time Frame: The 6 minute walk test measures distance (in meters) walked in a time of 6 minutes ]Baseline and 12 months post-intervention
- Change in nasal inflammatory mediators [ Time Frame: Baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months] ]Concentrations of inflammatory mediators relevant to allergic and non-allergic airway pathophysiology will be measured repeatedly at baseline and post-randomization in the nasal lining fluid by nasosorption. Mediators will include including Eotaxin, Eotaxin-3, GM-CSF, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, TARC, TNF-α, TNF-β, VEGF-A
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252235
|Contact: Mary B Rice, MD MPHemail@example.com|
|Contact: Lina Nurhussien, MPHfirstname.lastname@example.org|