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

• ClinicalTrials.gov Identifier: NCT03750292
• Recruitment Status: Completed
• First Posted: November 23, 2018
• Last Update Posted: February 10, 2022
• Sponsor: University of Rochester
• Information provided by (Responsible Party): Dan Croft, University of Rochester

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease	Device: HEPAirX air filter; Device: control air filter	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Residential Cleaning of Indoor Air to Reduce Acute Exacerbations of COPD (CARE): A Pilot Randomized Crossover Trial
• Actual Study Start Date: March 18, 2019
• Actual Primary Completion Date: March 26, 2021
• Actual Study Completion Date: March 26, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Mean change in St. George Respiratory Questionnaire [ Time Frame: baseline to 8 weeks ]
   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.
2. Mean change in St. George Respiratory Questionnaire [ Time Frame: 11 weeks to 19 weeks ]
   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.
3. Mean change in St. George Respiratory Questionnaire [ Time Frame: week 19 to week 31 ]
   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.
4. Mean change in daily step [ Time Frame: week 0 to week 8 ]
   Steps will be measured using a Fitbit step counter.
5. Mean change in daily step [ Time Frame: 11 weeks to 19 weeks ]
   Steps will be measured using a Fitbit step counter.

Secondary Outcome Measures :

1. mean plasma C-reactive protein level [ Time Frame: week 0 to week 19 ]
   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.
2. mean number of outpatient and inpatient visit for chronic obstructive pulmonary disorder exacerbations [ Time Frame: baseline to week 31 ]
   The number of exacerbations will be measured using retrospective review of Patient charts.
3. mean number of outpatient and inpatient visit for chronic obstructive pulmonary disorder exacerbations [ Time Frame: baseline to week 31 ]
   The number of exacerbations will be measured using patient report

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

United States, New York

University of Rochester Medical Center

Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

More Information

• Responsible Party: Dan Croft, Assistant Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT03750292
• Other Study ID Numbers: 72609
• First Posted: November 23, 2018
• Last Update Posted: February 10, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Tract Diseases