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Completed

NCT Number: NCT04252235

Home Air Purification for Eosinophilic COPD

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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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

air purifier

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.

Sham air purifier

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Other outcomes

  1. Change in nasal inflammatory mediators

    Time frame: Baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months]

    Concentrations of inflammatory mediators relevant to allergic and non-allergic airway pathophysiology will be measured repeatedly at baseline and post-randomization in the nasal lining fluid by nasosorption. Mediators will include including Eotaxin, Eotaxin-3, GM-CSF, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, TARC, TNF-α, TNF-β, VEGF-A

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

Registry information

Official study title

A Randomized Controlled Trial of Home Air Purification for Eosinophilic COPD

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2020
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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