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Home Air Purification for Eosinophilic COPD

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ClinicalTrials.gov Identifier: NCT04252235
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : July 29, 2020
Sponsor:
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Mary Rice, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE January 30, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date July 29, 2020
Estimated Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
Change in forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months] ]
FEV1 is the volume of air exhaled in the first second of a forced exhalation maneuver. Lower volumes indicate worse lung function.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • Change in health status (also called health-related quality of life) by St. George Respiratory Questionnaire [ Time Frame: Baseline [3 months before intervention and day of intervention] and post-intervention [6 months and 12 months] ]
    The St. George's Respiratory Questionnaire is scored from 0 to 100. Higher scores indicate more health impairment.
  • Change in respiratory symptoms [ Time Frame: Monthly for 3 months preintervention and 12 months post-intervention ]
    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.
  • Change in functional capacity by 6 minute walk test [ Time Frame: The 6 minute walk test measures distance (in meters) walked in a time of 6 minutes ]
    Baseline and 12 months post-intervention
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 31, 2020)
Change in nasal inflammatory mediators [ Time Frame: Baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months] ]
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-γ, IL-1α, IL-1β, 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-1α, MIP-1β, TARC, TNF-α, TNF-β, VEGF-A
Original Other Pre-specified Outcome Measures
 (submitted: January 30, 2020)
Change in nasal inflammatory mediators [ Time Frame: Baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months] ]
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.
 
Descriptive Information
Brief Title  ICMJE Home Air Purification for Eosinophilic COPD
Official Title  ICMJE A Randomized Controlled Trial of Home Air Purification for Eosinophilic COPD
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomized to receive real or sham HEPA filters in the bedroom and living room for a total of 12 months.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Sham air purifiers will be indistinguishable from real air purifiers. Only the research assistant installing the purifiers and the data coordinating center will have knowledge of assignment to real or sham purifiers.
Primary Purpose: Treatment
Condition  ICMJE
  • COPD
  • Eosinophilia
Intervention  ICMJE
  • 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.
  • Device: 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.
Study Arms  ICMJE
  • Sham Comparator: Sham air purifier
    Participants will receive a sham air purifier that will be installed in the bedroom and living room. These purifiers will make a noise, but will not filter the air.
    Intervention: Device: Sham air purifier
  • Experimental: True air purifier
    Participants will receive a HEPA air purifier in the bedroom and living room.
    Intervention: Device: Air purifier
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2025
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 on screening or >300 cells per μL in the past 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
  • Living in a home with a central air filtration system
  • Living with someone who smokes in the household
  • End stage chronic disease with life expectancy <2 years as determined by PI judgment (e.g. COPD on continuous oxygen even at rest, under evaluation or listed for lung transplantation, malignancy, severe cirrhosis, severe heart failure)
  • Chronic systemic steroids (≥ 3 months continuous use in past 12 months)
  • Living in location other than home (e.g. long term care facility)
  • Planning to change residence within the study period
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mary B Rice, MD MPH 617-667-5864 mrice1@bidmc.harvard.edu
Contact: Lina Nurhussien, MPH 617-667-3307 lnurhuss@bidmc.harvard.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04252235
Other Study ID Numbers  ICMJE 2019P001129
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: After study completion, data requests for post-hoc analyses may be submitted to the PI who will discuss each request with members of the research team and External Advisory Committee. If approved, we will facilitate secure access to data with appropriate coding files that will allow interpretation of the dataset. We will utilize data-sharing agreements to restrict the transfer of data, requiring that data be used only for research purposes. If excessive data preparation is needed, we will request funds from the requester to cover the additional personnel and resource costs.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
Time Frame: After study completion, requests for data sharing will be addressed within 3 months.
Access Criteria: Data requests must be accompanied by a data analysis plan, which includes the scientific background and rationale for the proposed analysis, variables needed, analytical approach, and qualifications of the research team. Investigators must be able to demonstrate they have the skills and resources to analyze the data and protect the data in a secure environment.
Responsible Party Mary Rice, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE National Institute of Environmental Health Sciences (NIEHS)
Investigators  ICMJE Not Provided
PRS Account Beth Israel Deaconess Medical Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP