<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02236858</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00085617</org_study_id>
    <secondary_id>1R01ES022607</secondary_id>
    <nct_id>NCT02236858</nct_id>
  </id_info>
  <brief_title>Clinical Trial of Air Cleaners to Improve Indoor Air Quality and COPD Health</brief_title>
  <official_title>Clinical Trial of Air Cleaners to Improve Indoor Air Quality and COPD Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Environmental Health Sciences (NIEHS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives (include all primary and secondary objectives)&#xD;
&#xD;
      Specific Aim #1: To determine whether an air cleaner intervention to improve home air quality&#xD;
      will improve respiratory symptoms, quality of life, lung function and reduce risk of&#xD;
      exacerbations in former smokers with COPD.&#xD;
&#xD;
      Hypothesis: An intervention using high-efficiency particulate air (HEPA) and carbon filter&#xD;
      air cleaners in homes of former smokers with COPD will improve respiratory symptoms, quality&#xD;
      of life, and lung function and reduce risk of COPD exacerbations compared with placebo (sham&#xD;
      air cleaners).&#xD;
&#xD;
      Specific Aim #2: To determine whether an air cleaner intervention to improve home air quality&#xD;
      will be associated with intermediate outcome measures known to be linked with long term&#xD;
      outcomes in COPD, including airway and systemic markers of inflammation and oxidative stress,&#xD;
      in former smokers with COPD.&#xD;
&#xD;
      Hypothesis 2: An intervention using HEPA and carbon filter air cleaners in homes of formers&#xD;
      smokers with COPD will be associated with lower levels of markers of inflammation and&#xD;
      oxidative stress known to be associated with adverse outcomes in patients with COPD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research is being done to learn whether an air cleaner intervention to improve home air&#xD;
      quality (particulate matter (PM) and nitrogen dioxide (NO2) reduction) will improve&#xD;
      respiratory symptoms, quality of life, lung function, and reduce risk of exacerbations in&#xD;
      former smokers with COPD.&#xD;
&#xD;
      The investigators will place air pollution monitors in the home to measure the air quality&#xD;
      over five 1-week periods (at 3 month and 1 week pre-intervention, and 1 week, 3 months and 6&#xD;
      months post-intervention). During each week of monitoring, the investigators will ask that a&#xD;
      diary be kept of breathing and how the participants are feeling every day.&#xD;
&#xD;
      Participant will have 5 home visits and 5 clinic visits and monthly telephone calls during&#xD;
      this time to see how the participant is feeling. One week after each home visit, the&#xD;
      monitoring equipment will be picked up. After the 2nd monitoring period, active or sham air&#xD;
      cleaners will be placed in home.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2014</start_date>
  <completion_date type="Actual">September 10, 2021</completion_date>
  <primary_completion_date type="Actual">February 21, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>Change from baseline and at 6 months post randomization</time_frame>
    <description>St. George's Respiratory Questionnaire (SGRQ). The total score is from 0 to 100. Higher scores indicate more limitations</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health care utilization</measure>
    <time_frame>Baseline through end of study (approximately 6 months post-randomization)</time_frame>
    <description>Aggregate Exacerbations including (need for oral corticosteroids or antibiotics for worsening respiratory symptoms, emergency department (ED) visit or hospitalization).&#xD;
During this 6 months exacerbations will be collected at monthly telephone calls and at 3 and 6 month clinic visits. Whether an exacerbation occurred over this 6 month period will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dyspnea (mMRC)</measure>
    <time_frame>Change from baseline and 3 months post-randomization</time_frame>
    <description>Dyspnea will be assessed using the modified medical research Council questionnaire (mMRC). The total score is from 0 (no dyspnea) to 2 (severe dyspnea).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dyspnea (mMRC)</measure>
    <time_frame>Change from baseline and 6 months post-randomization</time_frame>
    <description>Dyspnea will be assessed using the modified medical research Council questionnaire (mMRC). The total score is from 0 (no dyspnea) to 2 (severe dyspnea).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in COPD health status</measure>
    <time_frame>Change from baseline and 3 months post randomization</time_frame>
    <description>Functional status will be assessed with the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in COPD health status</measure>
    <time_frame>Change from baseline and 6 months post randomization</time_frame>
    <description>Functional status will be assessed with the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional status</measure>
    <time_frame>Change from baseline and 3 months post randomization</time_frame>
    <description>Functional status will be assessed with the 6 minute walk test. We will assess the distance (in meters) covered a time of 6 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional status</measure>
    <time_frame>Change from baseline and 6 months post randomization</time_frame>
    <description>Functional status will be assessed with the 6 minute walk test. We will assess the distance (in meters) covered a time of 6 minutes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">142</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease (COPD)</condition>
  <arm_group>
    <arm_group_label>Sham HEPA Air Cleaner</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham HEPA Air Cleaner and Delayed Intervention. Homes in the control group will receive sham air cleaners that have the internal HEPA and carbon filters removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HEPA Air Cleaner</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>HEPA Air Cleaner also containing carbon filters (Austin HealthMate HM400) and capable of removing PM and NO2 will be placed in the bedroom and room where the participant reports spending the most time. These air cleaners are suitably sized to provide clean air delivery rates for the rooms in which they will be placed. Participants will be instructed to run the air cleaners continually during the course of the study and the units will be modified to prevent them from being turned off by the participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HEPA Air Cleaner</intervention_name>
    <description>Air cleaners containing HEPA and carbon filters (Austin HealthMate HM400) and capable of removing PM and NO2 will be placed in the bedroom and room where the participant reports spending the most time.</description>
    <arm_group_label>HEPA Air Cleaner</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham HEPA Air Cleaner</intervention_name>
    <description>Homes in the control group will receive sham air cleaners that have the internal HEPA and carbon filters removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status.</description>
    <arm_group_label>Sham HEPA Air Cleaner</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 40 years,&#xD;
&#xD;
          -  Physician diagnosis of COPD,&#xD;
&#xD;
          -  Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced&#xD;
             Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC) ≤70% and FEV1 (% predicted)&#xD;
             &lt;80%,&#xD;
&#xD;
          -  Tobacco exposure ≥ 10 pack-years, and&#xD;
&#xD;
          -  Former smoker. We will employ a combination of self-report and a biochemical marker to&#xD;
             identify former-smokers. Exhaled CO (eCO) will be used as a marker of smoking status,&#xD;
             as it is easy to perform, provides immediate data and is non-invasive. Former-smokers&#xD;
             will be those who report no current smoking in the past 1 year AND have exhaled CO&#xD;
             levels ≤ 6ppm. This threshold was chosen to maximize the chance of distinguishing true&#xD;
             smokers and ex-smokers (&gt;95%).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic systemic corticosteroids (≥ 3 months continuous use in past 12 months),&#xD;
&#xD;
          -  Other chronic lung disease including asthma,&#xD;
&#xD;
          -  Living in location other than home (e.g., long term care facility) and&#xD;
&#xD;
          -  Home owner or home occupant planning to move or change residence within the study&#xD;
             period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadia N Hansel, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>February 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>September 13, 2021</last_update_submitted>
  <last_update_submitted_qc>September 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02236858
org study id: NA_00085617
secondary id: 1R01ES022607
nct id: NCT02236858
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objectives (include all primary and secondary objectives)

      Specific Aim #1: To determine whether an air cleaner intervention to improve home air quality
      will improve respiratory symptoms, quality of life, lung function and reduce risk of
      exacerbations in former smokers with COPD.

      Hypothesis: An intervention using high-efficiency particulate air (HEPA) and carbon filter
      air cleaners in homes of former smokers with COPD will improve respiratory symptoms, quality
      of life, and lung function and reduce risk of COPD exacerbations compared with placebo (sham
      air cleaners).

      Specific Aim #2: To determine whether an air cleaner intervention to improve home air quality
      will be associated with intermediate outcome measures known to be linked with long term
      outcomes in COPD, including airway and systemic markers of inflammation and oxidative stress,
      in former smokers with COPD.

      Hypothesis 2: An intervention using HEPA and carbon filter air cleaners in homes of formers
      smokers with COPD will be associated with lower levels of markers of inflammation and
      oxidative stress known to be associated with adverse outcomes in patients with COPD.
This research is being done to learn whether an air cleaner intervention to improve home air
      quality (particulate matter (PM) and nitrogen dioxide (NO2) reduction) will improve
      respiratory symptoms, quality of life, lung function, and reduce risk of exacerbations in
      former smokers with COPD.

      The investigators will place air pollution monitors in the home to measure the air quality
      over five 1-week periods (at 3 month and 1 week pre-intervention, and 1 week, 3 months and 6
      months post-intervention). During each week of monitoring, the investigators will ask that a
      diary be kept of breathing and how the participants are feeling every day.

      Participant will have 5 home visits and 5 clinic visits and monthly telephone calls during
      this time to see how the participant is feeling. One week after each home visit, the
      monitoring equipment will be picked up. After the 2nd monitoring period, active or sham air
      cleaners will be placed in home.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in Quality of Life
time frame: Change from baseline and at 6 months post randomization
description: St. George's Respiratory Questionnaire (SGRQ). The total score is from 0 to 100. Higher scores indicate more limitations
measure: Health care utilization
time frame: Baseline through end of study (approximately 6 months post-randomization)
description: Aggregate Exacerbations including (need for oral corticosteroids or antibiotics for worsening respiratory symptoms, emergency department (ED) visit or hospitalization).
During this 6 months exacerbations will be collected at monthly telephone calls and at 3 and 6 month clinic visits. Whether an exacerbation occurred over this 6 month period will be assessed.
measure: Change in Dyspnea (mMRC)
time frame: Change from baseline and 3 months post-randomization
description: Dyspnea will be assessed using the modified medical research Council questionnaire (mMRC). The total score is from 0 (no dyspnea) to 2 (severe dyspnea).
measure: Change in Dyspnea (mMRC)
time frame: Change from baseline and 6 months post-randomization
description: Dyspnea will be assessed using the modified medical research Council questionnaire (mMRC). The total score is from 0 (no dyspnea) to 2 (severe dyspnea).
measure: Change in COPD health status
time frame: Change from baseline and 3 months post randomization
description: Functional status will be assessed with the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control
measure: Change in COPD health status
time frame: Change from baseline and 6 months post randomization
description: Functional status will be assessed with the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control
measure: Change in Functional status
time frame: Change from baseline and 3 months post randomization
description: Functional status will be assessed with the 6 minute walk test. We will assess the distance (in meters) covered a time of 6 minutes.
measure: Change in Functional status
time frame: Change from baseline and 6 months post randomization
description: Functional status will be assessed with the 6 minute walk test. We will assess the distance (in meters) covered a time of 6 minutes.
arm group label: Sham HEPA Air Cleaner
arm group type: Sham Comparator
description: Sham HEPA Air Cleaner and Delayed Intervention. Homes in the control group will receive sham air cleaners that have the internal HEPA and carbon filters removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status.
arm group label: HEPA Air Cleaner
arm group type: Active Comparator
description: HEPA Air Cleaner also containing carbon filters (Austin HealthMate HM400) and capable of removing PM and NO2 will be placed in the bedroom and room where the participant reports spending the most time. These air cleaners are suitably sized to provide clean air delivery rates for the rooms in which they will be placed. Participants will be instructed to run the air cleaners continually during the course of the study and the units will be modified to prevent them from being turned off by the participants.
intervention type: Device
intervention name: HEPA Air Cleaner
description: Air cleaners containing HEPA and carbon filters (Austin HealthMate HM400) and capable of removing PM and NO2 will be placed in the bedroom and room where the participant reports spending the most time.
arm group label: HEPA Air Cleaner
intervention type: Device
intervention name: Sham HEPA Air Cleaner
description: Homes in the control group will receive sham air cleaners that have the internal HEPA and carbon filters removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status.
arm group label: Sham HEPA Air Cleaner
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Nadia N Hansel, MD, MPH
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive