Residential Cleaning of Indoor Air to Protect COPD Patients (CARE)

Residential Cleaning of Indoor Air to Reduce Acute Exacerbations of COPD (CARE): A Pilot Randomized Crossover Trial

This study looks at whether air cleaning devices put in the bedroom and living room of your home could reduce the irritation of your lungs and body that is caused by indoor air pollution. While participating in this study there will be two, 2 month long study segments (Study Period 1 and Study Period 2) where the air filter units, placed in your living room and bedroom windows, will be turned on at your home.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: HEPAirX air filter; Device: control air filter

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• severe COPD (FEV1 < 50%)
• live in Monroe County
• referred for pulmonary rehabilitation
• suffered from an AECOPD in the past year
• have standard sized windows in their bedroom and living room amenable to installation of the HEPAirX® device
• expect to sleep each night of the 4 months (2 months of Period 1, and 2 months of period 2) in either their bedroom or living room for at least 6 hours/night, and not use other air filtering devices during the study

Exclusion Criteria:

• under age 18
• smoking at the time of their prior COPD exacerbation
• current smokers
• those who live with an active smoker
• those with an occupation that has a high pollutant exposure (e.g. professional drivers)
• those who already have a home air filtration device (other than basic furnace filter)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEPAirX air filter	Device: HEPAirX air filter; It is a trademarked, patented (U.S. Patent # 7,802,443), U.S. FDA approved Class II medical re-circulating air cleaner, built by Air Innovations, Inc. (North Syracuse, NY) to provide improved indoor air quality in the bedrooms of asthmatic children. Units to be used in the proposed study have a 99.97% efficient filter for particles 0.3 µm in size. The device provides a clean air delivery rate (CADR) of 9 per hour with 1.8 of them being outdoor air.
Placebo Comparator: Control air filter	Device: control air filter; A placebo mode was added to the HEPAirX to provide only recirculation (without filtration or ventilation using outdoor air) and temperature control of the room air. The placebo filter is made of metal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in St. George Respiratory Questionnaire	The St. Georges Respiratory Questionnaire (SGRQ) is an established, clinically relevant measure of respiratory symptoms, activity level, and impacts on daily life, and is a measure of functional status regularly used and validated in COPD patient populations. The questionnaire is a fixed format 50 item survey completed by the study subject asking questions in three parts: 1) levels of symptomatology including frequency of wheezing, cough, sputum production, and breathlessness, including the duration of episodes of wheeze and breathlessness, 2) physical activities that may be caused or are limited by breathlessness, and 3) impacts of these symptoms. It is a self-assessment of respiratory symptoms and functional status, and provides a quantification of the impacts of airflow limitation on health and well-being. The scores range from 0 to 100 with higher number indicating worse outcomes.	baseline to 8 weeks
Mean Change in St. George Respiratory Questionnaire	The St. Georges Respiratory Questionnaire (SGRQ) is an established, clinically relevant measure of respiratory symptoms, activity level, and impacts on daily life, and is a measure of functional status regularly used and validated in COPD patient populations. The questionnaire is a fixed format 50 item survey completed by the study subject asking questions in three parts: 1) levels of symptomatology including frequency of wheezing, cough, sputum production, and breathlessness, including the duration of episodes of wheeze and breathlessness, 2) physical activities that may be caused or are limited by breathlessness, and 3) impacts of these symptoms. It is a self-assessment of respiratory symptoms and functional status, and provides a quantification of the impacts of airflow limitation on health and well-being. The scores range from 0 to 100 with higher number indicating worse outcomes.	11 weeks to 19 weeks
Mean Change in St. George Respiratory Questionnaire	The St. Georges Respiratory Questionnaire (SGRQ) is an established, clinically relevant measure of respiratory symptoms, activity level, and impacts on daily life, and is a measure of functional status regularly used and validated in COPD patient populations. The questionnaire is a fixed format 50 item survey completed by the study subject asking questions in three parts: 1) levels of symptomatology including frequency of wheezing, cough, sputum production, and breathlessness, including the duration of episodes of wheeze and breathlessness, 2) physical activities that may be caused or are limited by breathlessness, and 3) impacts of these symptoms. It is a self-assessment of respiratory symptoms and functional status, and provides a quantification of the impacts of airflow limitation on health and well-being. The scores range from 0 to 100 with higher number indicating worse outcomes.	week 19 to week 31
Mean Change in Daily Steps	Steps will be measured using a Fitbit step counter.	week 0 to week 8
Mean Change in Daily Step	Steps will be measured using a Fitbit step counter.	11 weeks to 19 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Plasma C-reactive Protein Level	Plasma C-reactive protein (CRP) is a measure of systemic inflammation, and is an acute phase protein known to increase in the hours and days following an inflammatory stimulus. C-reactive protein will be measured in plasma obtained from whole blood using standard procedures.	week 0 to week 19
Mean Number of Outpatient and Inpatient Visits for Chronic Obstructive Pulmonary Disorder Exacerbations	The number of exacerbations will be measured using retrospective review of Patient charts.	baseline to week 31
Mean Number of Outpatient and Inpatient Visit for Chronic Obstructive Pulmonary Disorder Exacerbations	The number of exacerbations will be measured using patient report	baseline to week 31

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2019
• Primary Completion (Actual): March 26, 2021
• Study Completion (Actual): March 26, 2021

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 72609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No