Home Air Purification for Eosinophilic COPD
A Randomized Controlled Trial of Home Air Purification for Eosinophilic COPD
1 other identifier
interventional
178
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
March 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedMarch 4, 2026
March 1, 2026
4.9 years
January 30, 2020
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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]
Change in respiratory symptoms
Monthly for 3 months preintervention and 12 months post-intervention
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
Other Outcomes (1)
Change in nasal inflammatory mediators
Baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months]
Study Arms (2)
Sham air purifier
SHAM COMPARATORParticipants 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
EXPERIMENTALParticipants will receive a HEPA air purifier in the bedroom and living room.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
Saeed MS, Denoncourt CM, Chao IA, Schortmann S, Nassikas NJ, Synn AJ, Koutrakis P, Coull BA, Kang CM, Wolfson JM, Ferguson ST, Rebuli ME, Jaspers I, Liu JP, Greco KF, Phipatanakul W, Rice MB. Protocol for the air purification for eosinophilic COPD study (APECS): a randomised controlled trial of home air filtration by HEPA. BMJ Open. 2024 Jan 18;14(1):e074655. doi: 10.1136/bmjopen-2023-074655.
PMID: 38238060DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary B Rice, MD MPH
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
January 30, 2020
First Posted
February 5, 2020
Study Start
March 15, 2021
Primary Completion
January 20, 2026
Study Completion
February 28, 2026
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- After study completion, requests for data sharing will be addressed within 3 months.
- Access Criteria
- Data requests must be accompanied by a data analysis plan, which includes the scientific background and rationale for the proposed analysis, variables needed, analytical approach, and qualifications of the research team. Investigators must be able to demonstrate they have the skills and resources to analyze the data and protect the data in a secure environment.
After study completion, data requests for post-hoc analyses may be submitted to the PI who will discuss each request with members of the research team and External Advisory Committee. If approved, we will facilitate secure access to data with appropriate coding files that will allow interpretation of the dataset. We will utilize data-sharing agreements to restrict the transfer of data, requiring that data be used only for research purposes. If excessive data preparation is needed, we will request funds from the requester to cover the additional personnel and resource costs.