Home Air Purification for Eosinophilic COPD

Beth Israel Lahey Health

Status: Active, not recruiting

Conditions: COPD; Eosinophilia

Treatments: Device: Air purifier; Device: Sham air purifier

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04252235

2019P001129

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 178 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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178 participants in 2 patient groups

Sham air purifier

Sham Comparator group

Description:

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.

Treatment:

Device: Sham air purifier

True air purifier

Experimental group

Description:

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

Treatment:

Device: Air purifier