<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/NCT02995733</url>
  </required_header>
  <id_info>
    <org_study_id>2016P001839</org_study_id>
    <nct_id>NCT02995733</nct_id>
  </id_info>
  <brief_title>Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief</brief_title>
  <acronym>PREPARE</acronym>
  <official_title>Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Academy of Family Physicians</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Asthma imposes a significant burden in the US in terms of morbidity, costs to society,&#xD;
      individual suffering, loss of productivity and mortality. African Americans (AA) and&#xD;
      Hispanic/Latinos (H/L) bear a disproportionate share of that morbidity. Despite national&#xD;
      guidelines for asthma treatment, the gap between these groups and whites has been stable or&#xD;
      widening. The need for pragmatic research to address the continuing burden is widely&#xD;
      recognized. Patients use asthma reliever inhalers to provide immediate relief of symptoms.&#xD;
      Controller inhalers (inhaled corticosteroids (ICS)) are intended to be used regularly to&#xD;
      prevent symptoms and attacks. Guidelines suggest that they be used daily, on a fixed basis,&#xD;
      in all but the mildest asthma. However, adherence by patients and implementation of&#xD;
      evidence-based guideline recommendations by clinicians has been poor. Gap analysis suggests&#xD;
      that it is difficult to improve adherence to the current recommendations without complex and&#xD;
      resource-intensive interventions. Studies have examined symptom-activated use of ICS&#xD;
      triggered by use of a reliever medication. The Investigators call this approach PARTICS -&#xD;
      Patient Activated Reliever-Triggered Inhaled CorticoSteroid. Explanatory, non-real world&#xD;
      studies suggest that PARTICS can produce up to 50% reductions in asthma attacks compared with&#xD;
      usual care, while reducing ICS use by half or more. These studies have been performed in&#xD;
      pre-selected populations, which represent less than 5% of asthma patients. The previous&#xD;
      studies have been done with repeated education and adherence checks in both the intervention&#xD;
      and control arms.&#xD;
&#xD;
      The investigators have consulted with AA and H/L patients, health care providers, leaders of&#xD;
      professional societies, advocacy groups, health policy leaders, pharmacists, and&#xD;
      pharmaceutical manufacturers. All groups have indicated that asthma decision making would be&#xD;
      changed if we demonstrated that implementing PARTICS improves important asthma outcomes such&#xD;
      as reducing exacerbations. The Investigators have designed a study with the stakeholders to&#xD;
      determine whether PARTICS can improve outcomes that are important to patients when&#xD;
      superimposed on a background provider-educated standard of care through the Asthma IQ system.&#xD;
      The Investigators propose a study entitled PREPARE: Patient Empowered Strategy to Reduce&#xD;
      Asthma Morbidity in Highly Impacted Populations. The Investigators aim to determine whether&#xD;
      PARTICS can reduce asthma morbidity in AA and H/L.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asthma imposes a significant burden on the US population in terms of morbidity, costs to&#xD;
      society, individual suffering, loss of productivity and mortality. African Americans (AA) and&#xD;
      Hispanic/Latinos (H/L) bear a disproportionate share of that morbidity. Despite introduction&#xD;
      of national guidelines for asthma treatment, the gap between these groups and whites has been&#xD;
      stable or widening. The need for pragmatic research to address the continuing burden is&#xD;
      widely recognized. Patients use asthma reliever inhalers to provide immediate relief of&#xD;
      symptoms. Controller inhalers (inhaled corticosteroids (ICS)) are intended to be used&#xD;
      regularly to prevent symptoms and attacks. Guidelines suggest that they be used daily, on a&#xD;
      fixed basis, in all but the mildest asthma. However, adherence by patients and implementation&#xD;
      of evidence-based guideline recommendations by clinicians has been poor. Gap analysis&#xD;
      suggests that it is difficult to improve adherence to the current recommendations without&#xD;
      complex and resource-intensive interventions.&#xD;
&#xD;
      Studies have examined symptom-activated use of ICS triggered by use of a reliever medication.&#xD;
      We call this approach PARTICS - Patient Activated Reliever-Triggered Inhaled CorticoSteroid.&#xD;
      Explanatory, non-real world studies suggest that PARTICS can produce up to 50% reductions in&#xD;
      asthma attacks compared with usual care, while reducing ICS use by half or more. However,&#xD;
      these studies have been performed in pre- selected populations, which represent less than 5%&#xD;
      of patients with asthma. They have been done with repeated education and adherence checks in&#xD;
      both the intervention and control arms.&#xD;
&#xD;
      The investigators have consulted with AA and H/L patients, health care providers, leaders of&#xD;
      professional societies, advocacy groups, health policy leaders, pharmacists, and&#xD;
      pharmaceutical manufacturers. All groups have indicated that asthma decision making would be&#xD;
      changed if it was demonstrated that implementing PARTICS improves important asthma outcomes&#xD;
      such as reducing rates of exacerbations. Together with our partners and stakeholders, the&#xD;
      investigators have designed a study to determine whether PARTICS can improve outcomes that&#xD;
      are important to patients when superimposed on a background provider-educated standard care&#xD;
      through the Asthma IQ system. The investigators therefore propose a study entitled PREPARE:&#xD;
      Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations. The aim&#xD;
      is to determine whether a PARTICS strategy can reduce asthma morbidity in AA and H/L. The&#xD;
      primary outcome will be asthma exacerbations which have been shown to be important to patient&#xD;
      and healthcare stakeholders. The secondary outcomes will include additional outcomes&#xD;
      important to patients (i.e. days lost from work or school, asthma control, &amp; asthma quality&#xD;
      of life). The investigators have broad input and involvement from multiple stakeholder groups&#xD;
      in study design, implementation, and commitments for dissemination. AA and H/L patients and&#xD;
      their advocates have been involved and will continue to play a central role in all phases of&#xD;
      the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
  <phase>Phase 4</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>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Asthma Exacerbations Per Year</measure>
    <time_frame>monthly through study completion an average of 15 months</time_frame>
    <description>Our primary outcome, the rate of asthma exacerbations per year, is defined as the number of exacerbations, emergency room visits, or hospitalizations requiring oral or parenteral corticosteroids, per patient per year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Asthma Control: Asthma Control Test (ACT) Score, Least-squares Mean Change From Baseline</measure>
    <time_frame>Monthly through study completion an average of 15 months</time_frame>
    <description>Asthma control represents the degree to which impairment (impact of asthma on patient's daily life) is minimized and the goals of therapy are met. The Asthma Control Test is a participant-administered tool for assessing the level of asthma control. Total scores range from 5 to 25, with a score of 20 to 25 indicating well-controlled asthma, a score of 16 to 19 indicating asthma that was not well controlled, and a score of 5 to 15 indicating very poorly controlled asthma. The minimal clinically important difference is 3 points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preference Based Quality of Life: Asthma Symptom Utility Index (ASUI), Least-squares Mean Change From Baseline</measure>
    <time_frame>Monthly through study completion an average of 15 months</time_frame>
    <description>The ideal outcome measure for any comparative effectiveness analysis captures the risks and benefits for each of the interventions from the patient's point of view. The use of a preference-based instrument, the Asthma Symptom Utility Index (ASUI), captures this important information. The Asthma Symptom Utility Index is a participant-administered tool for assessing preference-based quality of life. Scores range from 0 (worst possible symptoms) to 1 (no symptoms). The minimal clinically important difference is 0.09.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days Per Year Lost From Work or School/ Days Unable to Carry Out Usual Activities Due to Asthma</measure>
    <time_frame>Monthly through study completion an average of 15 months</time_frame>
    <description>Defined as days not able to work or go to school because of asthma symptoms OR days not able to carry out usual activities due to asthma</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1220</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>PARTICS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Provider-enhanced usual care arm; no change in asthma management</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PARTICS using QVAR</intervention_name>
    <description>Patient takes inhaled corticosteroid at the time of rescue inhaler use</description>
    <arm_group_label>PARTICS</arm_group_label>
    <other_name>Patient Activated Reliever-Triggered Inhaled CorticoSteroid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
          -  Black or Hispanic based on self-identification (Hispanic if identify as both)&#xD;
&#xD;
          -  Male and female, ages 18-75 years&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  Clinical history consistent with asthma for &gt; 1 year.&#xD;
&#xD;
          -  Prescribed ICS as daily maintenance therapy&#xD;
&#xD;
          -  Participant must also have an ACT score of 19 or less, or a history of one or more&#xD;
             exacerbations in the past year that required patient report of systemic corticosteroid&#xD;
             use.&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
          -  Life expectancy less than one year&#xD;
&#xD;
          -  Known allergy to the ICS inhaler used in the study&#xD;
&#xD;
          -  Having COPD or other chronic lung disease other than asthma; with the exception of the&#xD;
             following:&#xD;
&#xD;
               -  Dx of COPD in a never smoker without any other lung disease or any other disease&#xD;
                  that might cause airway obstruction such as: Cystic Fibrosis, Connective Tissue&#xD;
                  Disease, premature birth, organ transplantation, bronchiectasis, sarcoid, and&#xD;
                  obliterative bronchiolitis&#xD;
&#xD;
               -  Dx of COPD in former smoker with normal PFTs done after the person quit smoking&#xD;
&#xD;
               -  Dx of COPD in current smoker with normal PFTs done in past 24 months&#xD;
&#xD;
               -  Dx of COPD IN CURRENT OR FORMER SMOKER with obstruction on PFTs: normal diffusing&#xD;
                  capacity in past 24 months and demonstrated reversibility of 12% or more at any&#xD;
                  time&#xD;
&#xD;
          -  Regular systemic corticosteroid use daily or every other day for any reason-including&#xD;
             asthma or other medical reasons&#xD;
&#xD;
          -  Use of systemic corticosteroid, or visit to the doctor's office, emergency department&#xD;
             (ED) or urgent care, or overnight hospitalization for an asthma exacerbation in the&#xD;
             past month (can wait and re-check eligibility after one month)&#xD;
&#xD;
          -  Use of biologics (injections or infusion medicines): with the exception of the&#xD;
             following:&#xD;
&#xD;
               -  the patient has been on a stable dose of a biologic for at least 6 months and,&#xD;
&#xD;
               -  must have had an exacerbation at least 2 months after starting on a biologic to&#xD;
                  be considered eligible OR&#xD;
&#xD;
               -  must have a current ACT score &lt;=19 to be considered eligible.&#xD;
&#xD;
          -  Bronchial thermoplasty less than 6 months ago (can re-check eligibility 6 months after&#xD;
             procedure)&#xD;
&#xD;
          -  Another family member living in the same household already enrolled in study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elliot Israel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Denver Health and Hospital Authority</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grace Medical Home</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32827</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Central Florida</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32827</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Illinois- Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baystate Health Center</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mt. Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>25799</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atrium Health</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MetroHealth</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Puerto Rico</name>
      <address>
        <city>San Juan</city>
        <zip>00926</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>November 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <results_first_submitted>August 31, 2022</results_first_submitted>
  <results_first_submitted_qc>December 21, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 19, 2023</results_first_posted>
  <last_update_submitted>December 21, 2022</last_update_submitted>
  <last_update_submitted_qc>December 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Elliot Israel, MD</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>African Americans</keyword>
  <keyword>Hispanics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>September 13, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT02995733/Prot_SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>1220 participants were enrolled, however, 19 participants were not followed and were dropped from analysis due to the site closure. They were not included in the primary analyses but were included in safety reporting. Two sites were enrolling simultaneously and there was one additional participant enrolled accidentally.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PARTICS</title>
          <description>addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use&#xD;
PARTICS using QVAR: Patient takes inhaled corticosteroid at the time of rescue inhaler use</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Provider-enhanced usual care arm; no change in asthma management</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="609"/>
                <participants group_id="P2" count="611"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="542"/>
                <participants group_id="P2" count="557"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="54"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study site closed</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Removed by study team due to inappropriate behavior</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>19 participants were dropped from analysis due to the site closure. They were not followed and not included in any analyses.</population>
      <group_list>
        <group group_id="B1">
          <title>PARTICS</title>
          <description>addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use&#xD;
PARTICS using QVAR: Patient takes inhaled corticosteroid at the time of rescue inhaler use</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Provider-enhanced usual care arm; no change in asthma management</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="600"/>
            <count group_id="B2" value="601"/>
            <count group_id="B3" value="1201"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.3" spread="13.5"/>
                    <measurement group_id="B2" value="47.0" spread="13.9"/>
                    <measurement group_id="B3" value="47.7" spread="13.7"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="508"/>
                    <measurement group_id="B2" value="497"/>
                    <measurement group_id="B3" value="1005"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>African American/Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="303"/>
                    <measurement group_id="B2" value="300"/>
                    <measurement group_id="B3" value="603"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic/Latinx</title>
                  <measurement_list>
                    <measurement group_id="B1" value="297"/>
                    <measurement group_id="B2" value="301"/>
                    <measurement group_id="B3" value="598"/>
                  </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>Puerto Rico</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="549"/>
                    <measurement group_id="B2" value="550"/>
                    <measurement group_id="B3" value="1099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index (BMI) (kg/m2)</title>
          <units>kilograms per meters squared</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.2" spread="9.1"/>
                    <measurement group_id="B2" value="35.1" spread="9.5"/>
                    <measurement group_id="B3" value="35.1" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Obesity</title>
          <description>The body-mass index is the weight in kilograms divided by the square of the height in meters. Obesity was defined as a body-mass index of 30 or higher.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="421"/>
                    <measurement group_id="B2" value="403"/>
                    <measurement group_id="B3" value="824"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking status</title>
          <description>Current smokers were defined as participants who were currently smoking or had smoked within the previous year. Former smokers were participants who had not smoked in the previous year but had smoked at least 10 pack-years. Nonsmokers were those who had not smoked within the previous year and had smoked less than 10 pack-years.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Current smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="143"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Former smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="477"/>
                    <measurement group_id="B2" value="481"/>
                    <measurement group_id="B3" value="958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Nonsmoker or former smoker in smoking environment</title>
          <description>A smoking environment was defined as others regularly smoking in the participant's home, work, or car.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="203"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of pack-years of smoking</title>
          <population>376 participants answered questions about smoking pack-years. Non-smokers are those who have not smoked within 1 year and have smoked less than 10 pack-years in their lifetime. 143 are current smokers, 100 are former smokers, and 133 are non-smokers with less than 10 pack-years.</population>
          <units>pack-years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="186"/>
                    <count group_id="B3" value="376"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.4" spread="13.80"/>
                    <measurement group_id="B2" value="15.8" spread="19.79"/>
                    <measurement group_id="B3" value="14.1" spread="17.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Maintenance asthma medications: Inhaled glucocorticoid without long-acting beta-agonist</title>
          <description>Medication categories are not mutually exclusive and therefore are reported separately.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="171"/>
                    <measurement group_id="B2" value="169"/>
                    <measurement group_id="B3" value="340"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Maintenance asthma medications: Combination inhaled glucocorticoid with long-acting beta-agonist</title>
          <description>Medication categories are not mutually exclusive and therefore are reported separately.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="428"/>
                    <measurement group_id="B2" value="431"/>
                    <measurement group_id="B3" value="859"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Maintenance asthma medications: Long-acting muscarinic antagonist</title>
          <description>Medication categories are not mutually exclusive and therefore are reported separately.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Maintenance asthma medications: Leukotriene-receptor antagonist</title>
          <description>Medication categories are not mutually exclusive and therefore are reported separately.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="308"/>
                    <measurement group_id="B2" value="290"/>
                    <measurement group_id="B3" value="598"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Maintenance asthma medications: Biologic agent</title>
          <description>Medication categories are not mutually exclusive and therefore are reported separately. Biologic agents included injectable monoclonal antibody therapies targeting IgE, interleukin-5 or the interleukin-5 receptor, or the interleukin-4 receptor.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Use of quick-reliever nebulizer</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="408"/>
                    <measurement group_id="B2" value="396"/>
                    <measurement group_id="B3" value="804"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of quick-reliever nebulizations per week</title>
          <population>Only participants who reported using a nebulizer are included in this measure.</population>
          <units>Nebulizations per week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="408"/>
                    <count group_id="B2" value="396"/>
                    <count group_id="B3" value="804"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.7" spread="4.6"/>
                    <measurement group_id="B2" value="3.0" spread="4.8"/>
                    <measurement group_id="B3" value="2.9" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of coexisting conditions</title>
          <description>Coexisting conditions included heart disease, cancer (except skin cancer), stroke, diabetes, chronic kidney disease, chronic obstructive pulmonary disease, human immunodeficiency virus infection or acquired immunodeficiency syndrome, hypertension, depression, and sleep disorder.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="166"/>
                    <measurement group_id="B2" value="191"/>
                    <measurement group_id="B3" value="357"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="150"/>
                    <measurement group_id="B2" value="126"/>
                    <measurement group_id="B3" value="276"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="133"/>
                    <measurement group_id="B2" value="119"/>
                    <measurement group_id="B3" value="252"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="167"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 or more</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fractional exhaled nitric oxide (FeNO)</title>
          <population>1003 participants had FeNO data available for analysis.</population>
          <units>ppb</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="502"/>
                    <count group_id="B2" value="501"/>
                    <count group_id="B3" value="1003"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.7" spread="27.8"/>
                    <measurement group_id="B2" value="30.4" spread="34.9"/>
                    <measurement group_id="B3" value="28.6" spread="31.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fractional exhaled nitric oxide (FeNO), ≥30 ppb</title>
          <population>1003 participants had FeNO data available for analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="502"/>
                    <count group_id="B2" value="501"/>
                    <count group_id="B3" value="1003"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="148"/>
                    <measurement group_id="B2" value="154"/>
                    <measurement group_id="B3" value="302"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Absolute eosinophil count</title>
          <population>996 participants had eosinophil count data available for analysis.</population>
          <units>cells/μL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="502"/>
                    <count group_id="B2" value="494"/>
                    <count group_id="B3" value="996"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="245.5" spread="229.29"/>
                    <measurement group_id="B2" value="250.1" spread="247.48"/>
                    <measurement group_id="B3" value="247.8" spread="238.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Absolute eosinophil count</title>
          <population>996 participants had eosinophil count data available for analysis.</population>
          <units>cells/μL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="502"/>
                    <count group_id="B2" value="494"/>
                    <count group_id="B3" value="996"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="188" lower_limit="0" upper_limit="1938.8"/>
                    <measurement group_id="B2" value="195" lower_limit="0" upper_limit="3555.9"/>
                    <measurement group_id="B3" value="192" lower_limit="0" upper_limit="3555.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Absolute eosinophil count ≥300 cells/μL</title>
          <population>996 participants had eosinophil count data available for analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="502"/>
                    <count group_id="B2" value="494"/>
                    <count group_id="B3" value="996"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                    <measurement group_id="B2" value="137"/>
                    <measurement group_id="B3" value="265"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of ≥1 asthma exacerbation in past year</title>
          <description>Asthma exacerbation in the previous year was defined as a participant-reported emergency department or urgent care visit, hospitalization, or course of systemic glucocorticoids within the 12 months before randomization.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="440"/>
                    <measurement group_id="B2" value="427"/>
                    <measurement group_id="B3" value="867"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Asthma Control Test score</title>
          <description>The Asthma Control Test is a participant-administered tool for assessing the level of asthma control.Total scores range from 5 to 25, with a score of 20 to 25 indicating well-controlled asthma, a score of 16 to 19 indicating asthma that was not well controlled, and a score of 5 to 15 indicating very poorly controlled asthma. The minimal clinically important difference is 3 points.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.7" spread="4.4"/>
                    <measurement group_id="B2" value="14.5" spread="4.5"/>
                    <measurement group_id="B3" value="14.6" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Asthma Symptom Utility Index score</title>
          <description>The Asthma Symptom Utility Index is a participant-administered tool for assessing preference-based quality of life. Scores range from 0 (worst possible symptoms) to 1 (no symptoms). The minimal clinically important difference is 0.09.</description>
          <population>One participant in the Usual Care group is missing baseline ASUI data.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="600"/>
                    <count group_id="B3" value="1200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.67" spread="0.22"/>
                    <measurement group_id="B2" value="0.67" spread="0.21"/>
                    <measurement group_id="B3" value="0.67" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medication Adherence Report Scale-5 score</title>
          <description>The Medication Adherence Report Scale-5 measures participant-reported medication adherence. Mean scores are calculated from five items and range from 1 to 5, with higher scores indicating better adherence.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.2" spread="0.8"/>
                    <measurement group_id="B2" value="4.2" spread="0.8"/>
                    <measurement group_id="B3" value="4.2" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Low or marginal health literacy</title>
          <description>Health literacy was assessed with the Brief Health Literacy Scale, which measures participant-reported health literacy and consists of three items. Scoring low or marginal health literacy on any one item classifies a participant as having low or marginal health literacy.</description>
          <population>One participant in the PARTICS group is missing baseline data measuring health literacy.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="599"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participant-perceived overall health</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="600"/>
                    <count group_id="B2" value="601"/>
                    <count group_id="B3" value="1201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Excellent</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="128"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="B1" value="200"/>
                    <measurement group_id="B2" value="194"/>
                    <measurement group_id="B3" value="394"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fair</title>
                  <measurement_list>
                    <measurement group_id="B1" value="257"/>
                    <measurement group_id="B2" value="272"/>
                    <measurement group_id="B3" value="529"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Poor</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rate of Asthma Exacerbations Per Year</title>
        <description>Our primary outcome, the rate of asthma exacerbations per year, is defined as the number of exacerbations, emergency room visits, or hospitalizations requiring oral or parenteral corticosteroids, per patient per year</description>
        <time_frame>monthly through study completion an average of 15 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PARTICS</title>
            <description>addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use&#xD;
PARTICS using QVAR: Patient takes inhaled corticosteroid at the time of rescue inhaler use</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Provider-enhanced usual care arm; no change in asthma management</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Asthma Exacerbations Per Year</title>
          <description>Our primary outcome, the rate of asthma exacerbations per year, is defined as the number of exacerbations, emergency room visits, or hospitalizations requiring oral or parenteral corticosteroids, per patient per year</description>
          <units>Adjusted annualized exacerbations</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="600"/>
                <count group_id="O2" value="601"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.69" lower_limit="0.61" upper_limit="0.78"/>
                    <measurement group_id="O2" value="0.82" lower_limit="0.73" upper_limit="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Asthma exacerbation rates during follow-up between two randomized treatment arms are compared using the Andersen-Gill adaptation of time-to-event Cox proportional hazard model with robust standard errors to account for multiple occurrences of the outcome in each patient (Andersen Gill, 1982). This analysis is based on intention-to-treat (ITT) patient population.</non_inferiority_desc>
            <p_value>0.048</p_value>
            <method>Cox proportional hazard model</method>
            <method_desc>Pre-specified baseline covariates are adjusted in the model. A time-dependent covariate for the COVID pandemic is also included in adjustments.</method_desc>
            <param_type>Cox Proportional Hazard</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.720</ci_lower_limit>
            <ci_upper_limit>0.999</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Asthma Control: Asthma Control Test (ACT) Score, Least-squares Mean Change From Baseline</title>
        <description>Asthma control represents the degree to which impairment (impact of asthma on patient's daily life) is minimized and the goals of therapy are met. The Asthma Control Test is a participant-administered tool for assessing the level of asthma control. Total scores range from 5 to 25, with a score of 20 to 25 indicating well-controlled asthma, a score of 16 to 19 indicating asthma that was not well controlled, and a score of 5 to 15 indicating very poorly controlled asthma. The minimal clinically important difference is 3 points</description>
        <time_frame>Monthly through study completion an average of 15 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PARTICS</title>
            <description>addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use&#xD;
PARTICS using QVAR: Patient takes inhaled corticosteroid at the time of rescue inhaler use</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Provider-enhanced usual care arm; no change in asthma management</description>
          </group>
        </group_list>
        <measure>
          <title>Asthma Control: Asthma Control Test (ACT) Score, Least-squares Mean Change From Baseline</title>
          <description>Asthma control represents the degree to which impairment (impact of asthma on patient's daily life) is minimized and the goals of therapy are met. The Asthma Control Test is a participant-administered tool for assessing the level of asthma control. Total scores range from 5 to 25, with a score of 20 to 25 indicating well-controlled asthma, a score of 16 to 19 indicating asthma that was not well controlled, and a score of 5 to 15 indicating very poorly controlled asthma. The minimal clinically important difference is 3 points</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="600"/>
                <count group_id="O2" value="601"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" lower_limit="3.1" upper_limit="3.6"/>
                    <measurement group_id="O2" value="2.5" lower_limit="2.3" upper_limit="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Mixed model is used to compare the treatment effects. The response variable is ACT change at each monthly assessment from baseline. The covariates (included as fixed effects) include randomized treatment arm, continuous time of assessment as a linear and quadratic term and the interactions of the treatment arm with the time variables. Independent random effects include intercept and time variables. The model adjusts for all the baseline covariates included in the primary analysis.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.5</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Preference Based Quality of Life: Asthma Symptom Utility Index (ASUI), Least-squares Mean Change From Baseline</title>
        <description>The ideal outcome measure for any comparative effectiveness analysis captures the risks and benefits for each of the interventions from the patient's point of view. The use of a preference-based instrument, the Asthma Symptom Utility Index (ASUI), captures this important information. The Asthma Symptom Utility Index is a participant-administered tool for assessing preference-based quality of life. Scores range from 0 (worst possible symptoms) to 1 (no symptoms). The minimal clinically important difference is 0.09.</description>
        <time_frame>Monthly through study completion an average of 15 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PARTICS</title>
            <description>addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use&#xD;
PARTICS using QVAR: Patient takes inhaled corticosteroid at the time of rescue inhaler use</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Provider-enhanced usual care arm; no change in asthma management</description>
          </group>
        </group_list>
        <measure>
          <title>Preference Based Quality of Life: Asthma Symptom Utility Index (ASUI), Least-squares Mean Change From Baseline</title>
          <description>The ideal outcome measure for any comparative effectiveness analysis captures the risks and benefits for each of the interventions from the patient's point of view. The use of a preference-based instrument, the Asthma Symptom Utility Index (ASUI), captures this important information. The Asthma Symptom Utility Index is a participant-administered tool for assessing preference-based quality of life. Scores range from 0 (worst possible symptoms) to 1 (no symptoms). The minimal clinically important difference is 0.09.</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="600"/>
                <count group_id="O2" value="601"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" lower_limit="0.11" upper_limit="0.13"/>
                    <measurement group_id="O2" value="0.08" lower_limit="0.07" upper_limit="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Mixed model is used to compare the treatment effects. The response variable is ASUI change at each monthly assessment from baseline. The covariates (included as fixed effects) include randomized treatment arm, continuous time of assessment as a linear and quadratic term and the interactions of the treatment arm with the time variables. Independent random effects include intercept and time variables. The model adjusts for all the baseline covariates included in the primary analysis.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.02</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Days Per Year Lost From Work or School/ Days Unable to Carry Out Usual Activities Due to Asthma</title>
        <description>Defined as days not able to work or go to school because of asthma symptoms OR days not able to carry out usual activities due to asthma</description>
        <time_frame>Monthly through study completion an average of 15 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PARTICS</title>
            <description>addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use&#xD;
PARTICS using QVAR: Patient takes inhaled corticosteroid at the time of rescue inhaler use</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Provider-enhanced usual care arm; no change in asthma management</description>
          </group>
        </group_list>
        <measure>
          <title>Days Per Year Lost From Work or School/ Days Unable to Carry Out Usual Activities Due to Asthma</title>
          <description>Defined as days not able to work or go to school because of asthma symptoms OR days not able to carry out usual activities due to asthma</description>
          <units>days per year</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="600"/>
                <count group_id="O2" value="601"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.4" lower_limit="11.9" upper_limit="15.2"/>
                    <measurement group_id="O2" value="16.8" lower_limit="14.9" upper_limit="18.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Negative binomial regression model is used, with time as an offset to account for differential duration of follow-up. The model adjusts for all the baseline covariates included in the primary analysis.</non_inferiority_desc>
            <param_type>Rate ratio</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From enrollment to study completion, an average of 15 months per participant.</time_frame>
      <desc>SAE was defined as any event that resulted in death, hospitalization, persistent/significant disability, or congenital anomaly/birth defect; or was otherwise life-threatening. Data on adverse events that resulted in hospitalization or death were obtained by participant report or site report. Adverse events were not monitored/assessed with regard to the specific Adverse Event Term.</desc>
      <group_list>
        <group group_id="E1">
          <title>PARTICS</title>
          <description>addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use&#xD;
PARTICS using QVAR: Patient takes inhaled corticosteroid at the time of rescue inhaler use</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Provider-enhanced usual care arm; no change in asthma management</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-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="3" subjects_at_risk="609"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="611"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="75" subjects_at_risk="609"/>
                <counts group_id="E2" subjects_affected="74" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hematology/oncology</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E2" events="11" subjects_affected="4" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac events</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="609"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal disorders</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="609"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Unclassified elsewhere</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="609"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Immune system disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="609"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Metabolism and nutrition disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="609"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous system disorders</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="609"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric disorders</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E2" events="6" subjects_affected="2" subjects_at_risk="611"/>
              </event>
              <event>
                <sub_title>Substance abuse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal/urinary disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="609"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Reproductive system and breast disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="68" subjects_affected="43" subjects_at_risk="609"/>
                <counts group_id="E2" events="85" subjects_affected="45" subjects_at_risk="611"/>
              </event>
              <event>
                <sub_title>Respiratory, thoracic, mediastinal disorders</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="609"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vascular disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="609"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="609"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="611"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Dr. Elliot Israel</name_or_title>
      <organization>Brigham and Women's Hospital</organization>
      <phone>617-732-8110</phone>
      <email>eisrael@bwh.harvard.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/NCT02995733
org study id: 2016P001839
nct id: NCT02995733
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Asthma imposes a significant burden in the US in terms of morbidity, costs to society,
      individual suffering, loss of productivity and mortality. African Americans (AA) and
      Hispanic/Latinos (H/L) bear a disproportionate share of that morbidity. Despite national
      guidelines for asthma treatment, the gap between these groups and whites has been stable or
      widening. The need for pragmatic research to address the continuing burden is widely
      recognized. Patients use asthma reliever inhalers to provide immediate relief of symptoms.
      Controller inhalers (inhaled corticosteroids (ICS)) are intended to be used regularly to
      prevent symptoms and attacks. Guidelines suggest that they be used daily, on a fixed basis,
      in all but the mildest asthma. However, adherence by patients and implementation of
      evidence-based guideline recommendations by clinicians has been poor. Gap analysis suggests
      that it is difficult to improve adherence to the current recommendations without complex and
      resource-intensive interventions. Studies have examined symptom-activated use of ICS
      triggered by use of a reliever medication. The Investigators call this approach PARTICS -
      Patient Activated Reliever-Triggered Inhaled CorticoSteroid. Explanatory, non-real world
      studies suggest that PARTICS can produce up to 50% reductions in asthma attacks compared with
      usual care, while reducing ICS use by half or more. These studies have been performed in
      pre-selected populations, which represent less than 5% of asthma patients. The previous
      studies have been done with repeated education and adherence checks in both the intervention
      and control arms.

      The investigators have consulted with AA and H/L patients, health care providers, leaders of
      professional societies, advocacy groups, health policy leaders, pharmacists, and
      pharmaceutical manufacturers. All groups have indicated that asthma decision making would be
      changed if we demonstrated that implementing PARTICS improves important asthma outcomes such
      as reducing exacerbations. The Investigators have designed a study with the stakeholders to
      determine whether PARTICS can improve outcomes that are important to patients when
      superimposed on a background provider-educated standard of care through the Asthma IQ system.
      The Investigators propose a study entitled PREPARE: Patient Empowered Strategy to Reduce
      Asthma Morbidity in Highly Impacted Populations. The Investigators aim to determine whether
      PARTICS can reduce asthma morbidity in AA and H/L.
Asthma imposes a significant burden on the US population in terms of morbidity, costs to
      society, individual suffering, loss of productivity and mortality. African Americans (AA) and
      Hispanic/Latinos (H/L) bear a disproportionate share of that morbidity. Despite introduction
      of national guidelines for asthma treatment, the gap between these groups and whites has been
      stable or widening. The need for pragmatic research to address the continuing burden is
      widely recognized. Patients use asthma reliever inhalers to provide immediate relief of
      symptoms. Controller inhalers (inhaled corticosteroids (ICS)) are intended to be used
      regularly to prevent symptoms and attacks. Guidelines suggest that they be used daily, on a
      fixed basis, in all but the mildest asthma. However, adherence by patients and implementation
      of evidence-based guideline recommendations by clinicians has been poor. Gap analysis
      suggests that it is difficult to improve adherence to the current recommendations without
      complex and resource-intensive interventions.

      Studies have examined symptom-activated use of ICS triggered by use of a reliever medication.
      We call this approach PARTICS - Patient Activated Reliever-Triggered Inhaled CorticoSteroid.
      Explanatory, non-real world studies suggest that PARTICS can produce up to 50% reductions in
      asthma attacks compared with usual care, while reducing ICS use by half or more. However,
      these studies have been performed in pre- selected populations, which represent less than 5%
      of patients with asthma. They have been done with repeated education and adherence checks in
      both the intervention and control arms.

      The investigators have consulted with AA and H/L patients, health care providers, leaders of
      professional societies, advocacy groups, health policy leaders, pharmacists, and
      pharmaceutical manufacturers. All groups have indicated that asthma decision making would be
      changed if it was demonstrated that implementing PARTICS improves important asthma outcomes
      such as reducing rates of exacerbations. Together with our partners and stakeholders, the
      investigators have designed a study to determine whether PARTICS can improve outcomes that
      are important to patients when superimposed on a background provider-educated standard care
      through the Asthma IQ system. The investigators therefore propose a study entitled PREPARE:
      Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations. The aim
      is to determine whether a PARTICS strategy can reduce asthma morbidity in AA and H/L. The
      primary outcome will be asthma exacerbations which have been shown to be important to patient
      and healthcare stakeholders. The secondary outcomes will include additional outcomes
      important to patients (i.e. days lost from work or school, asthma control, & asthma quality
      of life). The investigators have broad input and involvement from multiple stakeholder groups
      in study design, implementation, and commitments for dissemination. AA and H/L patients and
      their advocates have been involved and will continue to play a central role in all phases of
      the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Rate of Asthma Exacerbations Per Year
time frame: monthly through study completion an average of 15 months
description: Our primary outcome, the rate of asthma exacerbations per year, is defined as the number of exacerbations, emergency room visits, or hospitalizations requiring oral or parenteral corticosteroids, per patient per year
measure: Asthma Control: Asthma Control Test (ACT) Score, Least-squares Mean Change From Baseline
time frame: Monthly through study completion an average of 15 months
description: Asthma control represents the degree to which impairment (impact of asthma on patient's daily life) is minimized and the goals of therapy are met. The Asthma Control Test is a participant-administered tool for assessing the level of asthma control. Total scores range from 5 to 25, with a score of 20 to 25 indicating well-controlled asthma, a score of 16 to 19 indicating asthma that was not well controlled, and a score of 5 to 15 indicating very poorly controlled asthma. The minimal clinically important difference is 3 points
measure: Preference Based Quality of Life: Asthma Symptom Utility Index (ASUI), Least-squares Mean Change From Baseline
time frame: Monthly through study completion an average of 15 months
description: The ideal outcome measure for any comparative effectiveness analysis captures the risks and benefits for each of the interventions from the patient's point of view. The use of a preference-based instrument, the Asthma Symptom Utility Index (ASUI), captures this important information. The Asthma Symptom Utility Index is a participant-administered tool for assessing preference-based quality of life. Scores range from 0 (worst possible symptoms) to 1 (no symptoms). The minimal clinically important difference is 0.09.
measure: Days Per Year Lost From Work or School/ Days Unable to Carry Out Usual Activities Due to Asthma
time frame: Monthly through study completion an average of 15 months
description: Defined as days not able to work or go to school because of asthma symptoms OR days not able to carry out usual activities due to asthma
arm group label: PARTICS
arm group type: Active Comparator
description: addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use
arm group label: Usual Care
arm group type: No Intervention
description: Provider-enhanced usual care arm; no change in asthma management
intervention type: Drug
intervention name: PARTICS using QVAR
description: Patient takes inhaled corticosteroid at the time of rescue inhaler use
arm group label: PARTICS
other name: Patient Activated Reliever-Triggered Inhaled CorticoSteroid
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Elliot Israel, MD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
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country: Puerto Rico
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Elliot Israel, MD
investigator title: Professor of Medicine
mesh term: Asthma
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 