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 Title of Study: “A Randomized Controlled Trial of Home Air Purification for Eosinophilic COPD”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: June 30, 2025
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.
- 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.
- 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.
Arms, Groups and Cohorts
- 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.
- Experimental: True air purifier
- Participants will receive a HEPA air purifier in the bedroom and living room.
Clinical Trial Outcome Measures
- 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
Participating in This Clinical Trial
- 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 on screening or >300 cells per μL in the past 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 – End stage chronic disease with life expectancy <2 years as determined by PI judgment (e.g. COPD on continuous oxygen even at rest, under evaluation or listed for lung transplantation, malignancy, severe cirrhosis, severe heart failure) – Chronic systemic steroids (≥ 3 months continuous use in past 12 months) – Living in location other than home (e.g. long term care facility) – Planning to change residence within the study period
Gender Eligibility: All
Minimum Age: 40 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- National Institute of Environmental Health Sciences (NIEHS)
- Provider of Information About this Clinical Study
- Principal Investigator: Mary Rice, Assistant Professor of Medicine – Beth Israel Deaconess Medical Center
- Overall Official(s)
- Mary B Rice, MD MPH, Principal Investigator, Beth Israel Deaconess Medical Center
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