COPD, Eosinophilia
Conditions
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.
Interventions
DEVICEAir 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.
DEVICESham 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.
Sponsors
Beth Israel Deaconess Medical Center
National Institute of Environmental Health Sciences (NIEHS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in forced expiratory volume in 1 second (FEV1) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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] | The St. George's Respiratory Questionnaire is scored from 0 to 100. Higher scores indicate more health impairment. |
| Change in respiratory symptoms | 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 | The 6 minute walk test measures distance (in meters) walked in a time of 6 minutes | Baseline and 12 months post-intervention |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMary B Rice, MD MPH
Beth Israel Deaconess Medical Center
Outcome results
None listed