Home Air Purification for Eosinophilic COPD

COPD Clinical Trial

Official title:

A Randomized Controlled Trial of Home Air Purification for Eosinophilic COPD

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04252235
• Other study ID #: 2019P001129
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Eosinophilia

Intervention

Device:
• Air 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.
• Sham 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in nasal inflammatory mediators	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-?, IL-1a, IL-1ß, 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-1a, MIP-1ß, TARC, TNF-a, TNF-ß, VEGF-A	Baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months]
Primary	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	Change in health status (also called health-related quality of life) by St. George Respiratory Questionnaire	The St. George's Respiratory Questionnaire is scored from 0 to 100. Higher scores indicate more health impairment.	Baseline [3 months before intervention and day of intervention] and post-intervention [6 months and 12 months]
Secondary	Change in respiratory symptoms	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.	Monthly for 3 months preintervention and 12 months post-intervention
Secondary	Change in functional capacity by 6 minute walk test	Baseline and 12 months post-intervention	The 6 minute walk test measures distance (in meters) walked in a time of 6 minutes