<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/NCT02251379</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00093323</org_study_id>
    <nct_id>NCT02251379</nct_id>
  </id_info>
  <brief_title>Environmental Control as Add-on Therapy in Childhood Asthma</brief_title>
  <acronym>ECATCh</acronym>
  <official_title>Environmental Control as Add-on Therapy in Childhood Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effects of adding on an environmental home intervention to standard&#xD;
      asthma medication management on controller medication requirements among children and&#xD;
      adolescents with asthma. The investigators hypothesize that the addition of an&#xD;
      individually-tailored, multi-faceted Environmental Control Strategy (ECS) to guidelines-based&#xD;
      controller medication will result in less controller medication requirement and allergic&#xD;
      inflammation than controller medication alone among urban asthmatic children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a parallel arm study of an individually tailored, multi-faceted ECS plus&#xD;
      controller medication titration versus controller medication titration alone. After a 4-week&#xD;
      run-in period to stabilize the asthma, the investigators will randomize 200 Baltimore&#xD;
      children with persistent asthma and a recent exacerbation in a 1:1 ratio to the two arms and&#xD;
      follow the children for six months. There will be five clinic visits and three home visits&#xD;
      over this time period for clinical and home assessments, respectively. There will be up to&#xD;
      four environmental intervention visits for participants randomized to the environmental&#xD;
      control plus controller medication group. The environmental modules include mouse, cockroach,&#xD;
      furry pets, dust mites, and smoking. Air purifiers and laundered bedding are also included in&#xD;
      this arm. Participants randomized to the controller medication group have the option of&#xD;
      having one home visit after completing the study at which the participants will receive home&#xD;
      intervention services that the environmental control plus controller medication group&#xD;
      received. Participants will have repeated assessment of: controller medication requirements;&#xD;
      secondary clinical, physiologic, and inflammatory outcomes; and particulate matter (PM), air&#xD;
      nicotine, and allergen levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">November 2018</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Medication Treatment Step Assigned</measure>
    <time_frame>6 month clinic visit</time_frame>
    <description>The controller medication treatment step that was assigned at the visit, which is based on the current controller medication treatment step and the current level of asthma control. The range is from 0-6, with 0 indicating no controller medication and 6 indicating high dose inhaled corticosteroids plus long-acting beta agonist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Daily Inhaled Corticosteroid Dose</measure>
    <time_frame>6 months</time_frame>
    <description>micrograms of inhaled corticosteroids (daily)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exhaled Nitric Oxide</measure>
    <time_frame>6 months</time_frame>
    <description>Exhaled nitric oxide in parts per billion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Asthma Symptom Days</measure>
    <time_frame>6 months</time_frame>
    <description>Number of asthma symptom days in the past two weeks will be a measure of asthma control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Asthma Exacerbations</measure>
    <time_frame>6 months</time_frame>
    <description>Asthma exacerbations will be assessed by number of acute visits to the emergency department (ED), hospitalizations and urgent doctor visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEV1/FVC</measure>
    <time_frame>6 months</time_frame>
    <description>Forced expiratory volume at one second/forced vital capacity (FEV1/FVC) will be evaluated as a continuous variable. This is a ratio without any units.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">155</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>ECS + Medication Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Environmental Control Strategy (&quot;Home Environmental Intervention&quot;) plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medication Group Alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Flovent Diskus</intervention_name>
    <description>Inhaled corticosteroids</description>
    <arm_group_label>ECS + Medication Group</arm_group_label>
    <arm_group_label>Medication Group Alone</arm_group_label>
    <other_name>Flovent Diskus, 50 mcg, 100mcg, 250 mcg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home Environmental Intervention</intervention_name>
    <description>Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding</description>
    <arm_group_label>ECS + Medication Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Advair Diskus</intervention_name>
    <description>inhaled corticosteroids + long-acting beta agonist</description>
    <arm_group_label>ECS + Medication Group</arm_group_label>
    <arm_group_label>Medication Group Alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have physician-diagnosed asthma at least 1 year prior to the baseline visit, or asthma&#xD;
             symptoms for at least 1 year&#xD;
&#xD;
          -  Meet criteria for current persistent asthma defined as either:&#xD;
&#xD;
               1. On a long-term controller medication for asthma, or&#xD;
&#xD;
               2. Meet National Asthma Education and Prevention Program (NAEPP) guideline&#xD;
                  requirements for persistent disease:(46)&#xD;
&#xD;
          -  Asthma symptoms 3 or more days per week over the past 2 weeks or&#xD;
&#xD;
          -  Nocturnal asthma symptoms at least 3 times in the past month&#xD;
&#xD;
          -  Have evidence of uncontrolled disease as defined by at least one of the following:&#xD;
&#xD;
               1. One asthma-related unscheduled visit to an emergency department (ED), clinic or&#xD;
                  urgent care facility in the previous 12 mo&#xD;
&#xD;
               2. One asthma-related overnight hospitalization in the previous 12 mo&#xD;
&#xD;
               3. One or more bursts of oral corticosteroids in the previous 12 mo&#xD;
&#xD;
          -  Reside within a geographic area of the study site so that home visits are feasible.&#xD;
&#xD;
          -  Have no plans to move within the upcoming 6 months&#xD;
&#xD;
          -  Have insurance to cover prescription medications.&#xD;
&#xD;
          -  Have a positive skin test (net wheal ≥2mm) to cat, dog, mouse, cockroach, or dust&#xD;
             mites or have a positive cat, dog, mouse, German cockroach, or D. farinae-specific&#xD;
             immunoglobulin E (IgE) test, as quantified using the ImmunoCAP system (≥0.35 kU/L)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lung disease, other than asthma, that requires daily medication&#xD;
&#xD;
          -  Cardiovascular disease that requires daily medication, excluding hypertension&#xD;
&#xD;
          -  Taking a beta-blocker&#xD;
&#xD;
          -  Allergy to dairy&#xD;
&#xD;
          -  On Xolair &lt; 5 months&#xD;
&#xD;
          -  On immunotherapy and has not reached maintenance dose&#xD;
&#xD;
          -  Sleeping in another home 4 or more nights/week&#xD;
&#xD;
          -  Active smoker defined as a positive urine screen for high levels of urine cotinine&#xD;
&#xD;
          -  Unable to access areas of home necessary to conduct extermination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth C Matsui, MD MHS</last_name>
    <role>Study Chair</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Meredith McCormack, MD MHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Corinne Keet, MD PHD</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>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <results_first_submitted>October 15, 2019</results_first_submitted>
  <results_first_submitted_qc>October 15, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 4, 2019</results_first_posted>
  <last_update_submitted>November 8, 2019</last_update_submitted>
  <last_update_submitted_qc>November 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluticasone</mesh_term>
    <mesh_term>Xhance</mesh_term>
    <mesh_term>Fluticasone-Salmeterol Drug Combination</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 3, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT02251379/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ECS + Medication Group</title>
          <description>The Environmental Control Strategy (&quot;Home Environmental Intervention&quot;) plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
        </group>
        <group group_id="P2">
          <title>Medication Group Alone</title>
          <description>inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ECS + Medication Group</title>
          <description>The Environmental Control Strategy (&quot;Home Environmental Intervention&quot;) plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
        </group>
        <group group_id="B2">
          <title>Medication Group Alone</title>
          <description>inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="77"/>
            <count group_id="B2" value="78"/>
            <count group_id="B3" value="155"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.1" spread="3.3"/>
                    <measurement group_id="B2" value="10.1" spread="3.3"/>
                    <measurement group_id="B3" value="10.1" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="151"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="139"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>The treatment step assigned</title>
          <description>The controller medication treatment step that was assigned at the visit, which is based on the current controller medication treatment step and the current level of asthma control. The range is from 0-6, with 0 indicating no controller medication and 6 indicating high dose inhaled corticosteroids plus long-acting beta agonist.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.34" spread="1.56"/>
                    <measurement group_id="B2" value="4.56" spread="1.57"/>
                    <measurement group_id="B3" value="4.45" spread="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Medication Treatment Step Assigned</title>
        <description>The controller medication treatment step that was assigned at the visit, which is based on the current controller medication treatment step and the current level of asthma control. The range is from 0-6, with 0 indicating no controller medication and 6 indicating high dose inhaled corticosteroids plus long-acting beta agonist.</description>
        <time_frame>6 month clinic visit</time_frame>
        <population>participants completing the final 6 month follow-up visit</population>
        <group_list>
          <group group_id="O1">
            <title>ECS + Medication Group</title>
            <description>The Environmental Control Strategy (&quot;Home Environmental Intervention&quot;) plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
          </group>
          <group group_id="O2">
            <title>Medication Group Alone</title>
            <description>inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
          </group>
        </group_list>
        <measure>
          <title>The Medication Treatment Step Assigned</title>
          <description>The controller medication treatment step that was assigned at the visit, which is based on the current controller medication treatment step and the current level of asthma control. The range is from 0-6, with 0 indicating no controller medication and 6 indicating high dose inhaled corticosteroids plus long-acting beta agonist.</description>
          <population>participants completing the final 6 month follow-up visit</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.03" spread="1.91"/>
                    <measurement group_id="O2" value="4.05" spread="1.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Daily Inhaled Corticosteroid Dose</title>
        <description>micrograms of inhaled corticosteroids (daily)</description>
        <time_frame>6 months</time_frame>
        <population>participants who completed the final follow-up visit at 6 months</population>
        <group_list>
          <group group_id="O1">
            <title>ECS + Medication Group</title>
            <description>The Environmental Control Strategy (&quot;Home Environmental Intervention&quot;) plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
          </group>
          <group group_id="O2">
            <title>Medication Group Alone</title>
            <description>inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
          </group>
        </group_list>
        <measure>
          <title>Daily Inhaled Corticosteroid Dose</title>
          <description>micrograms of inhaled corticosteroids (daily)</description>
          <population>participants who completed the final follow-up visit at 6 months</population>
          <units>micrograms/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="557.5" spread="347.8"/>
                    <measurement group_id="O2" value="527.7" spread="401.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Exhaled Nitric Oxide</title>
        <description>Exhaled nitric oxide in parts per billion.</description>
        <time_frame>6 months</time_frame>
        <population>participants completing the final follow-up visit at 6 months with valid exhaled nitric oxide measurement. Not all participants had valid measures.</population>
        <group_list>
          <group group_id="O1">
            <title>ECS + Medication Group</title>
            <description>The Environmental Control Strategy (&quot;Home Environmental Intervention&quot;) plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
          </group>
          <group group_id="O2">
            <title>Medication Group Alone</title>
            <description>inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
          </group>
        </group_list>
        <measure>
          <title>Exhaled Nitric Oxide</title>
          <description>Exhaled nitric oxide in parts per billion.</description>
          <population>participants completing the final follow-up visit at 6 months with valid exhaled nitric oxide measurement. Not all participants had valid measures.</population>
          <units>parts per billion</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" lower_limit="10" upper_limit="38"/>
                    <measurement group_id="O2" value="20" lower_limit="8" upper_limit="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Asthma Symptom Days</title>
        <description>Number of asthma symptom days in the past two weeks will be a measure of asthma control.</description>
        <time_frame>6 months</time_frame>
        <population>participants who completed the final follow-up visit at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>ECS + Medication Group</title>
            <description>The Environmental Control Strategy (&quot;Home Environmental Intervention&quot;) plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
          </group>
          <group group_id="O2">
            <title>Medication Group Alone</title>
            <description>inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Asthma Symptom Days</title>
          <description>Number of asthma symptom days in the past two weeks will be a measure of asthma control.</description>
          <population>participants who completed the final follow-up visit at 6 months.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="3.2"/>
                    <measurement group_id="O2" value="2.7" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Asthma Exacerbations</title>
        <description>Asthma exacerbations will be assessed by number of acute visits to the emergency department (ED), hospitalizations and urgent doctor visits.</description>
        <time_frame>6 months</time_frame>
        <population>participants completing the 6 month follow-up visit</population>
        <group_list>
          <group group_id="O1">
            <title>ECS + Medication Group</title>
            <description>The Environmental Control Strategy (&quot;Home Environmental Intervention&quot;) plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
          </group>
          <group group_id="O2">
            <title>Medication Group Alone</title>
            <description>inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Asthma Exacerbations</title>
          <description>Asthma exacerbations will be assessed by number of acute visits to the emergency department (ED), hospitalizations and urgent doctor visits.</description>
          <population>participants completing the 6 month follow-up visit</population>
          <units>acute visits</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>FEV1/FVC</title>
        <description>Forced expiratory volume at one second/forced vital capacity (FEV1/FVC) will be evaluated as a continuous variable. This is a ratio without any units.</description>
        <time_frame>6 months</time_frame>
        <population>participants completing the 6 month follow-up visit</population>
        <group_list>
          <group group_id="O1">
            <title>ECS + Medication Group</title>
            <description>The Environmental Control Strategy (&quot;Home Environmental Intervention&quot;) plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
          </group>
          <group group_id="O2">
            <title>Medication Group Alone</title>
            <description>inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
          </group>
        </group_list>
        <measure>
          <title>FEV1/FVC</title>
          <description>Forced expiratory volume at one second/forced vital capacity (FEV1/FVC) will be evaluated as a continuous variable. This is a ratio without any units.</description>
          <population>participants completing the 6 month follow-up visit</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.3" spread="8.1"/>
                    <measurement group_id="O2" value="80.8" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the enrollment period, approximately 7 months</time_frame>
      <desc>Hospitalizations, including asthma-related hospitalizations, were considered serious adverse events. Participants were asked at each clinic visit about adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>ECS + Medication Group</title>
          <description>The Environmental Control Strategy (&quot;Home Environmental Intervention&quot;) plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
        </group>
        <group group_id="E2">
          <title>Medication Group Alone</title>
          <description>inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)&#xD;
Flovent Diskus: Inhaled corticosteroids&#xD;
Advair Diskus: inhaled corticosteroids + long-acting beta agonist</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>hospitalization</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>hospitalization</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>asthma hospitalization</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E2" events="11" subjects_affected="8" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Corinne Keet</name_or_title>
      <organization>Johns Hopkins University</organization>
      <phone>410-955-5883</phone>
      <email>ckeet1@jhmi.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02251379
org study id: NA_00093323
nct id: NCT02251379
lead sponsor: 
has dmc: Yes
This study evaluates the effects of adding on an environmental home intervention to standard
      asthma medication management on controller medication requirements among children and
      adolescents with asthma. The investigators hypothesize that the addition of an
      individually-tailored, multi-faceted Environmental Control Strategy (ECS) to guidelines-based
      controller medication will result in less controller medication requirement and allergic
      inflammation than controller medication alone among urban asthmatic children.
The study is a parallel arm study of an individually tailored, multi-faceted ECS plus
      controller medication titration versus controller medication titration alone. After a 4-week
      run-in period to stabilize the asthma, the investigators will randomize 200 Baltimore
      children with persistent asthma and a recent exacerbation in a 1:1 ratio to the two arms and
      follow the children for six months. There will be five clinic visits and three home visits
      over this time period for clinical and home assessments, respectively. There will be up to
      four environmental intervention visits for participants randomized to the environmental
      control plus controller medication group. The environmental modules include mouse, cockroach,
      furry pets, dust mites, and smoking. Air purifiers and laundered bedding are also included in
      this arm. Participants randomized to the controller medication group have the option of
      having one home visit after completing the study at which the participants will receive home
      intervention services that the environmental control plus controller medication group
      received. Participants will have repeated assessment of: controller medication requirements;
      secondary clinical, physiologic, and inflammatory outcomes; and particulate matter (PM), air
      nicotine, and allergen levels.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Medication Treatment Step Assigned
time frame: 6 month clinic visit
description: The controller medication treatment step that was assigned at the visit, which is based on the current controller medication treatment step and the current level of asthma control. The range is from 0-6, with 0 indicating no controller medication and 6 indicating high dose inhaled corticosteroids plus long-acting beta agonist.
measure: Daily Inhaled Corticosteroid Dose
time frame: 6 months
description: micrograms of inhaled corticosteroids (daily)
measure: Exhaled Nitric Oxide
time frame: 6 months
description: Exhaled nitric oxide in parts per billion.
measure: Number of Asthma Symptom Days
time frame: 6 months
description: Number of asthma symptom days in the past two weeks will be a measure of asthma control.
measure: Number of Asthma Exacerbations
time frame: 6 months
description: Asthma exacerbations will be assessed by number of acute visits to the emergency department (ED), hospitalizations and urgent doctor visits.
measure: FEV1/FVC
time frame: 6 months
description: Forced expiratory volume at one second/forced vital capacity (FEV1/FVC) will be evaluated as a continuous variable. This is a ratio without any units.
arm group label: ECS + Medication Group
arm group type: Experimental
description: The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)
arm group label: Medication Group Alone
arm group type: Active Comparator
description: inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)
intervention type: Drug
intervention name: Flovent Diskus
description: Inhaled corticosteroids
arm group label: ECS + Medication Group
arm group label: Medication Group Alone
other name: Flovent Diskus, 50 mcg, 100mcg, 250 mcg
intervention type: Other
intervention name: Home Environmental Intervention
description: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding
arm group label: ECS + Medication Group
intervention type: Drug
intervention name: Advair Diskus
description: inhaled corticosteroids + long-acting beta agonist
arm group label: ECS + Medication Group
arm group label: Medication Group Alone
criteria: 
gender: All
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: No
last name: Elizabeth C Matsui, MD MHS
role: Study Chair
affiliation: Johns Hopkins University
last name: Meredith McCormack, MD MHS
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Corinne Keet, MD PHD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
mesh term: Fluticasone
mesh term: Xhance
mesh term: Fluticasone-Salmeterol Drug Combination
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 