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

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ClinicalTrials.gov Identifier: NCT03750292
Recruitment Status : Not yet recruiting
First Posted : November 22, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Dan Croft, University of Rochester

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

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.




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



Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750292


Contacts
Contact: Daniel Croft, MD 585-275-4862 daniel_croft@urmc.rochester.edu

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester

Responsible Party: Dan Croft, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03750292     History of Changes
Other Study ID Numbers: 72609
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases