Clinical trial NCT04252235: Home Air Purification for Eosinophilic COPD
Official title: A Randomized Controlled Trial of Home Air Purification for Eosinophilic COPD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COPD
Eosinophilia
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2020-02-05
Enrollment: 178
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive real or sham HEPA filters in the bedroom and living room for a total of 12 months.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in forced expiratory volume in 1 second (FEV1)
timeFrame: Baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months]
Secondary outcomes:
measure: Change in health status (also called health-related quality of life) by St. George Respiratory Questionnaire
timeFrame: Baseline [3 months before intervention and day of intervention] and post-intervention [6 months and 12 months]
measure: Change in respiratory symptoms
timeFrame: Monthly for 3 months preintervention and 12 months post-intervention
measure: Change in functional capacity by 6 minute walk test
timeFrame: The 6 minute walk test measures distance (in meters) walked in a time of 6 minutes
Other outcomes:
measure: Change in nasal inflammatory mediators
timeFrame: Baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months]
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Mary B Rice, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: