<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/NCT02258893</url>
  </required_header>
  <id_info>
    <org_study_id>1308012531</org_study_id>
    <secondary_id>5R01ES023505-05</secondary_id>
    <nct_id>NCT02258893</nct_id>
  </id_info>
  <brief_title>Indoor Air Pollution and Children With Asthma: An Intervention Trial</brief_title>
  <acronym>CAPS</acronym>
  <official_title>Indoor Nitrogen Dioxide Exposure and Children With Asthma: An Intervention Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Environmental Health Sciences (NIEHS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether reducing indoor exposure to NO2 and&#xD;
      particles improves respiratory health in children with asthma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We have designed a randomized, double-blind, triple cross-over intervention study to examine&#xD;
      the efficacy of indoor NO2 reduction on reducing asthma severity. Since particles and NO2 are&#xD;
      both byproducts of combustion and associated with gas stove use, the intervention protocol&#xD;
      includes a condition using a filter designed to remove particles also implicated in asthma&#xD;
      exacerbations (e.g., coarse, fine and ultrafine particles including airborne mold spores and&#xD;
      allergens) while leaving NO2 virtually untouched. Primary and secondary aims of the trial&#xD;
      include, respectively, determining whether reducing exposure to NO2 and particles compared to&#xD;
      a &quot;control&quot; (non-filtered) condition results in a clinically significant reduction in asthma&#xD;
      severity measured by a difference in days of symptoms between intervention arms.&#xD;
&#xD;
      Families with asthmatic children age 5-11 will be recruited from selected communities using&#xD;
      a: (1) flyers distributed in elementary schools, (2) postcards send to families from&#xD;
      purchased mailing lists, (3) posters placed in community buildings (libraries, clinics,&#xD;
      etc.), (4) online (Facebook, Craigslist), and (5) letter mailed to families targeted through&#xD;
      Yale Joint Data Analytics Team (JDAT). Volunteers will be screened for preliminary&#xD;
      eligibility based on household characteristics and active asthmatic status. Potentially&#xD;
      eligible families will have homes with a gas cooking stove and seven rooms or fewer.&#xD;
      Potentially eligible children will be aged 5-11; have asthma symptoms and/or medication use&#xD;
      consistent with severity score categories 2 (mild persistent), 3 (moderate), or 4 (severe)&#xD;
      during the previous 12 months; and reside at least 5 days and nights every week in the&#xD;
      eligible home.&#xD;
&#xD;
      Households meeting these preliminary criteria will be asked to participate in passive NO2&#xD;
      sampling. A single Palmes tube will be sent to the home for placement in the main living&#xD;
      space for one week. Families will be called after one week and instructed to cap and return&#xD;
      the NO2 monitor in a pre-paid mailer. Families of children living in homes where the one-week&#xD;
      integrated average NO2 concentration is ≥ 15 ppb will be invited to participate. We will&#xD;
      permit enrollment of more than one eligible child per family. Participating families will be&#xD;
      randomized into one of 6 treatment sequences each requiring 3 periods of 4-weeks preceded by&#xD;
      a 1-week washout period. Randomization will be blocked so that for every 18 subjects&#xD;
      randomized there will be 3 in each sequence. Randomization will be conducted blindly by the&#xD;
      data management department such that each scheduled initial interview/air cleaner&#xD;
      installation is assigned a treatment sequence (referring to machines and filters already on&#xD;
      site). Minimization techniques will be used to balance the randomized allocation as&#xD;
      necessary. Total subject participation time up to 18 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">August 31, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Days with symptoms</measure>
    <time_frame>Final 14 days of intervention</time_frame>
    <description>The maximum of the following variables reported over the 2-week recall period: (1) number of days with wheezing, chest tightness, or persistent cough; (2) number of nights of sleep disturbance; (3) number of days when activities were affected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Days of wheeze</measure>
    <time_frame>Post 4 week intervention</time_frame>
    <description>As measured by self report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Night symptoms</measure>
    <time_frame>Post 4 week intervention</time_frame>
    <description>As measured by self report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue medication use</measure>
    <time_frame>Post 4 week intervention</time_frame>
    <description>As measured by self report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Score</measure>
    <time_frame>Last 4 weeks of intervention</time_frame>
    <description>The score is adapted from the Global Initiative for Asthma Guidelines which incorporates type and frequency of symptoms and medications. The symptom score portion, is a 5-level score calculated based on symptoms during the last 4-weeks of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Restricted Activity</measure>
    <time_frame>Post 4 week intervention</time_frame>
    <description>Activity Restrictions as measured by self report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Missed days of school</measure>
    <time_frame>Post 4 week intervention</time_frame>
    <description>As measured by self report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hospitalizations</measure>
    <time_frame>Post 4 week intervention</time_frame>
    <description>As measured by self report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Emergency Room Visits</measure>
    <time_frame>Post 4 week intervention</time_frame>
    <description>As measured by self report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Doctors Visits</measure>
    <time_frame>Post 4 week intervention</time_frame>
    <description>As measured by self report</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">116</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>NO2 Scrubber, then HEPA filter, then Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of NO2 Scrubber, then HEPA filter, then Control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NO2 Scrubber, then Control, then HEPA filter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of NO2 Scrubber, then Control, then HEPA filter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HEPA filter, then NO2 scrubber, then Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of HEPA filter, then NO2 scrubber, then Control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HEPA filter, then Control, then NO2 scrubber</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of HEPA filter, then Control, then NO2 scrubber</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control, then HEPA filter, then NO2 scrubber</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of Control, then HEPA filter, then NO2 scrubber</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control, then NO2 scrubber, then HEPA filter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of Control, then NO2 scrubber, then HEPA filter</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NO2 Scrubber</intervention_name>
    <description>an NO2 scrubber that removes NO2 and particles</description>
    <arm_group_label>Control, then HEPA filter, then NO2 scrubber</arm_group_label>
    <arm_group_label>Control, then NO2 scrubber, then HEPA filter</arm_group_label>
    <arm_group_label>HEPA filter, then Control, then NO2 scrubber</arm_group_label>
    <arm_group_label>HEPA filter, then NO2 scrubber, then Control</arm_group_label>
    <arm_group_label>NO2 Scrubber, then Control, then HEPA filter</arm_group_label>
    <arm_group_label>NO2 Scrubber, then HEPA filter, then Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HEPA filter</intervention_name>
    <description>a HEPA filter that removes 95% of suspended particles ≥ 0.003 μm in size (but does not remove NO2)</description>
    <arm_group_label>Control, then HEPA filter, then NO2 scrubber</arm_group_label>
    <arm_group_label>Control, then NO2 scrubber, then HEPA filter</arm_group_label>
    <arm_group_label>HEPA filter, then Control, then NO2 scrubber</arm_group_label>
    <arm_group_label>HEPA filter, then NO2 scrubber, then Control</arm_group_label>
    <arm_group_label>NO2 Scrubber, then Control, then HEPA filter</arm_group_label>
    <arm_group_label>NO2 Scrubber, then HEPA filter, then Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>a &quot;control&quot; filter designed to be the same size and weight as the other two filters, but filters neither NO2 nor particles</description>
    <arm_group_label>Control, then HEPA filter, then NO2 scrubber</arm_group_label>
    <arm_group_label>Control, then NO2 scrubber, then HEPA filter</arm_group_label>
    <arm_group_label>HEPA filter, then Control, then NO2 scrubber</arm_group_label>
    <arm_group_label>HEPA filter, then NO2 scrubber, then Control</arm_group_label>
    <arm_group_label>NO2 Scrubber, then Control, then HEPA filter</arm_group_label>
    <arm_group_label>NO2 Scrubber, then HEPA filter, then Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  5-11 years of age, enrolled in grades K-5 and living in the recruitment area (CT, MA)&#xD;
&#xD;
          -  [The screening questionnaire will determine asthma symptoms in the past 12 months&#xD;
             (wheeze, persistent cough, shortness of breath, chest tightness); and asthma&#xD;
             medication use in the past 12 months (short-acting β2-agonists, long-acting&#xD;
             β2-agonists, inhaled steroids, oral steroids, theophylline, cromones, and/or&#xD;
             leukotriene inhibitors). Based on symptoms and medication, asthma severity will be&#xD;
             categorized with a score adapted from the Global Initiative for Asthma guidelines&#xD;
             (1=mild transient, 2=mild persistent, 3=moderate, 4=severe). Only children in&#xD;
             categories 2 (mild persistent, 3 (moderate) or 4 (severe) will be eligible.]&#xD;
&#xD;
          -  For potential subjects satisfying these inclusion criteria, a passive NO2 monitor will&#xD;
             be sent to the home for placement in the main living space for one week. Families will&#xD;
             be called after one week and instructed to cap and return the NO2 monitor in a&#xD;
             pre-paid mailer. Families of children living in homes where the one-week integrated&#xD;
             average NO2 concentration is ≥ 15 ppb will be invited to participate. We will permit&#xD;
             the enrollment of more than one eligible child per family.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Using steroid medication for a condition other than asthma&#xD;
&#xD;
          -  Chronic respiratory condition other than asthma&#xD;
&#xD;
          -  Intention to move or relocate within 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian Leaderer, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Bracken, PhD MPH FACE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Theodore Holford, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Janneane Gent, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</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>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>November 19, 2020</last_update_submitted>
  <last_update_submitted_qc>November 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nitrogen Dioxide</keyword>
  <keyword>Parts per billion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT02258893
org study id: 1308012531
secondary id: 5R01ES023505-05
nct id: NCT02258893
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether reducing indoor exposure to NO2 and
      particles improves respiratory health in children with asthma.
We have designed a randomized, double-blind, triple cross-over intervention study to examine
      the efficacy of indoor NO2 reduction on reducing asthma severity. Since particles and NO2 are
      both byproducts of combustion and associated with gas stove use, the intervention protocol
      includes a condition using a filter designed to remove particles also implicated in asthma
      exacerbations (e.g., coarse, fine and ultrafine particles including airborne mold spores and
      allergens) while leaving NO2 virtually untouched. Primary and secondary aims of the trial
      include, respectively, determining whether reducing exposure to NO2 and particles compared to
      a "control" (non-filtered) condition results in a clinically significant reduction in asthma
      severity measured by a difference in days of symptoms between intervention arms.

      Families with asthmatic children age 5-11 will be recruited from selected communities using
      a: (1) flyers distributed in elementary schools, (2) postcards send to families from
      purchased mailing lists, (3) posters placed in community buildings (libraries, clinics,
      etc.), (4) online (Facebook, Craigslist), and (5) letter mailed to families targeted through
      Yale Joint Data Analytics Team (JDAT). Volunteers will be screened for preliminary
      eligibility based on household characteristics and active asthmatic status. Potentially
      eligible families will have homes with a gas cooking stove and seven rooms or fewer.
      Potentially eligible children will be aged 5-11; have asthma symptoms and/or medication use
      consistent with severity score categories 2 (mild persistent), 3 (moderate), or 4 (severe)
      during the previous 12 months; and reside at least 5 days and nights every week in the
      eligible home.

      Households meeting these preliminary criteria will be asked to participate in passive NO2
      sampling. A single Palmes tube will be sent to the home for placement in the main living
      space for one week. Families will be called after one week and instructed to cap and return
      the NO2 monitor in a pre-paid mailer. Families of children living in homes where the one-week
      integrated average NO2 concentration is ≥ 15 ppb will be invited to participate. We will
      permit enrollment of more than one eligible child per family. Participating families will be
      randomized into one of 6 treatment sequences each requiring 3 periods of 4-weeks preceded by
      a 1-week washout period. Randomization will be blocked so that for every 18 subjects
      randomized there will be 3 in each sequence. Randomization will be conducted blindly by the
      data management department such that each scheduled initial interview/air cleaner
      installation is assigned a treatment sequence (referring to machines and filters already on
      site). Minimization techniques will be used to balance the randomized allocation as
      necessary. Total subject participation time up to 18 weeks.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Days with symptoms
time frame: Final 14 days of intervention
description: The maximum of the following variables reported over the 2-week recall period: (1) number of days with wheezing, chest tightness, or persistent cough; (2) number of nights of sleep disturbance; (3) number of days when activities were affected.
measure: Days of wheeze
time frame: Post 4 week intervention
description: As measured by self report
measure: Night symptoms
time frame: Post 4 week intervention
description: As measured by self report
measure: Rescue medication use
time frame: Post 4 week intervention
description: As measured by self report
measure: Symptom Score
time frame: Last 4 weeks of intervention
description: The score is adapted from the Global Initiative for Asthma Guidelines which incorporates type and frequency of symptoms and medications. The symptom score portion, is a 5-level score calculated based on symptoms during the last 4-weeks of the intervention.
measure: Amount of Restricted Activity
time frame: Post 4 week intervention
description: Activity Restrictions as measured by self report
measure: Number of Missed days of school
time frame: Post 4 week intervention
description: As measured by self report
measure: Number of Hospitalizations
time frame: Post 4 week intervention
description: As measured by self report
measure: Number of Emergency Room Visits
time frame: Post 4 week intervention
description: As measured by self report
measure: Number of Doctors Visits
time frame: Post 4 week intervention
description: As measured by self report
arm group label: NO2 Scrubber, then HEPA filter, then Control
arm group type: Experimental
description: Participants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of NO2 Scrubber, then HEPA filter, then Control.
arm group label: NO2 Scrubber, then Control, then HEPA filter
arm group type: Experimental
description: Participants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of NO2 Scrubber, then Control, then HEPA filter
arm group label: HEPA filter, then NO2 scrubber, then Control
arm group type: Experimental
description: Participants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of HEPA filter, then NO2 scrubber, then Control
arm group label: HEPA filter, then Control, then NO2 scrubber
arm group type: Experimental
description: Participants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of HEPA filter, then Control, then NO2 scrubber
arm group label: Control, then HEPA filter, then NO2 scrubber
arm group type: Experimental
description: Participants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of Control, then HEPA filter, then NO2 scrubber
arm group label: Control, then NO2 scrubber, then HEPA filter
arm group type: Experimental
description: Participants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of Control, then NO2 scrubber, then HEPA filter
intervention type: Other
intervention name: NO2 Scrubber
description: an NO2 scrubber that removes NO2 and particles
arm group label: Control, then HEPA filter, then NO2 scrubber
arm group label: Control, then NO2 scrubber, then HEPA filter
arm group label: HEPA filter, then Control, then NO2 scrubber
arm group label: HEPA filter, then NO2 scrubber, then Control
arm group label: NO2 Scrubber, then Control, then HEPA filter
arm group label: NO2 Scrubber, then HEPA filter, then Control
intervention type: Other
intervention name: HEPA filter
description: a HEPA filter that removes 95% of suspended particles ≥ 0.003 μm in size (but does not remove NO2)
arm group label: Control, then HEPA filter, then NO2 scrubber
arm group label: Control, then NO2 scrubber, then HEPA filter
arm group label: HEPA filter, then Control, then NO2 scrubber
arm group label: HEPA filter, then NO2 scrubber, then Control
arm group label: NO2 Scrubber, then Control, then HEPA filter
arm group label: NO2 Scrubber, then HEPA filter, then Control
intervention type: Other
intervention name: Control
description: a "control" filter designed to be the same size and weight as the other two filters, but filters neither NO2 nor particles
arm group label: Control, then HEPA filter, then NO2 scrubber
arm group label: Control, then NO2 scrubber, then HEPA filter
arm group label: HEPA filter, then Control, then NO2 scrubber
arm group label: HEPA filter, then NO2 scrubber, then Control
arm group label: NO2 Scrubber, then Control, then HEPA filter
arm group label: NO2 Scrubber, then HEPA filter, then Control
criteria: 
gender: All
minimum age: 5 Years
maximum age: 11 Years
healthy volunteers: No
last name: Brian Leaderer, PhD, MPH
role: Principal Investigator
affiliation: Yale University
last name: Michael Bracken, PhD MPH FACE
role: Principal Investigator
affiliation: Yale University
last name: Theodore Holford, PhD
role: Principal Investigator
affiliation: Yale University
last name: Janneane Gent, PhD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma