Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
NCT Number: NCT04252235
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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Notify Me40 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: The 6 minute walk test measures distance (in meters) walked in a time of 6 minutes
Baseline and 12 months post-intervention
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
Beth Israel Deaconess Medical Center
Other
A Randomized Controlled Trial of Home Air Purification for Eosinophilic COPD
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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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