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Completed

NCT Number: NCT03750292

Residential Cleaning of Indoor Air to Protect COPD Patients

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HEPAirX air filter

Device

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.

control air filter

Device

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.

Primary outcomes

  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 Steps

    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 outcomes

  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 Visits 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

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Acronym: CARE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2018
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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