Home Air Purification for Eosinophilic COPD

Study Overview
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Brief Summary
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This study evaluates the influence of home air purification on the lung health of adults with eosinophilic COPD. Half of the participants will receive real air purifiers (HEPA filters) and half will receive sham air purifiers.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of Home Air Purification for Eosinophilic COPD

Conditions
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COPD, Eosinophilia

Intervention / Treatment
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* Device: Air purifier
* Device: Sham air purifier


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 40 years or more Physician diagnosis of COPD [Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC) ≤70% and FEV1 (% predicted) <80%] Blood eosinophil count of >=150 cells per μL at screening or in the previous year Former smoker with tobacco exposure of >=10 pack-years Exclusion Criteria: Inability to complete monthly questionnaires Inability to perform lung function testing Regularly using a portable HEPA air purifier in the home at time of enrollment End stage chronic disease with life expectancy <2 years as determined by PI judgment Living in location other than home (e.g. long term care facility) Planning to change residence within the study period

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham air purifier<br>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<br>* 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.<br>|
| Experimental: True air purifier<br>Participants will receive a HEPA air purifier in the bedroom and living room. | Device: Air purifier<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in forced expiratory volume in 1 second (FEV1) | FEV1 is the volume of air exhaled in the first second of a forced exhalation maneuver. Lower volumes indicate worse lung function. | Baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health status (also called health-related quality of life) by St. George Respiratory Questionnaire | The St. George's Respiratory Questionnaire is scored from 0 to 100. Higher scores indicate more health impairment. | Baseline [3 months before intervention and day of intervention] and post-intervention [6 months and 12 months] | 
| Change in respiratory symptoms | 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. | Monthly for 3 months preintervention and 12 months post-intervention | 
| Change in functional capacity by 6 minute walk test | Baseline and 12 months post-intervention | The 6 minute walk test measures distance (in meters) walked in a time of 6 minutes |