Home Air Purification for Eosinophilic COPD

Not Applicable

Active, not recruiting

• Conditions: COPD; Eosinophilia
• Interventions: Device: Sham air purifier; Device: Air purifier

• Registration Number: NCT04252235
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-02-05
• Study Start: 2021-03-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-01-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 178

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham air purifier	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.
True air purifier	Air purifier	Participants will receive a HEPA air purifier in the bedroom and living room.

Primary Outcome Measures

Name	Time	Method
Change in forced expiratory volume in 1 second (FEV1)	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.

Secondary Outcome Measures

Name	Time	Method
Change in functional capacity by 6 minute walk test	The 6 minute walk test measures distance (in meters) walked in a time of 6 minutes	Baseline and 12 months post-intervention
Change in respiratory symptoms	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 health status (also called health-related quality of life) by St. George Respiratory Questionnaire	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.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States