Home Air Purification for Eosinophilic COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2026-01-30

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.

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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.

Conditions

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COPD Eosinophilia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to receive real or sham HEPA filters in the bedroom and living room for a total of 12 months.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type SHAM_COMPARATOR

Sham air purifier

Intervention Type DEVICE

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.

True air purifier

Participants will receive a HEPA air purifier in the bedroom and living room.

Group Type EXPERIMENTAL

Air purifier

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No