<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/NCT04462224</url>
  </required_header>
  <id_info>
    <org_study_id>HS-3476</org_study_id>
    <nct_id>NCT04462224</nct_id>
  </id_info>
  <brief_title>Creation of Home-based Asthma Real-World Measures With Mobile Health Study</brief_title>
  <acronym>CHARM</acronym>
  <official_title>Creation of Home-based Asthma Real-World Measures With Mobile Health (CHARM) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Jewish Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Jewish Health</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Four novel biologic therapies (benralizumab, dupilumab, mepolizumab, reslizumab) have been&#xD;
      recently approved for moderate-to-severe, eosinophilic or oral steroid-dependent asthma. The&#xD;
      efficacy and safety of these therapies have been determined primarily by randomized clinical&#xD;
      trials that compared annualized rates of significant asthma exacerbations (SAEs), lung&#xD;
      function changes, and standardized symptom survey score changes in therapy-treated subjects&#xD;
      in comparison to placebo matched controls. Yet, there is increasing interest to assess the&#xD;
      efficacy, health benefits, and safety in medical therapies using real-world evidence (RWE).&#xD;
      Further, home monitoring of asthma using mobile health (mHealth) technology may help&#xD;
      scientists develop new and more sensitive indicators of asthma control that could improve&#xD;
      clinical care. The hypothesis is that real world evidence, collected at home using several&#xD;
      mobile health technologies, will help determine the efficacy, health benefits, and side&#xD;
      effects of these therapies.&#xD;
&#xD;
      Objectives&#xD;
&#xD;
        1. Assess real-world evidence (RWE) indicators of worsening and improving asthma.&#xD;
           Scientists will measure steps per day, duration and vigor of exercise per day, sleep&#xD;
           quality, and the number of awakenings per night using Fitbit activity trackers.&#xD;
           Scientists will measure symptoms using once-monthly custom survey delivered to&#xD;
           participant smartphones via Twilio. Rescue medication use and adherence to maintenance&#xD;
           medications may be measured using digital inhaler devices. Adherence to biologic use&#xD;
           using HealthBeacon smart sharps containers may be measured. Measures collected will be&#xD;
           correlated to patient-reported significant asthma exacerbations (SAEs), lung function&#xD;
           (FEV1), and the asthma control test (ACT) collected in clinic every 3 months.&#xD;
&#xD;
        2. Use RWE to determine responses to biologic therapies. Scientists will combine at-home&#xD;
           and clinic data to determine responses to biologics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 11, 2021</start_date>
  <completion_date type="Anticipated">July 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Asthma Control Test</measure>
    <time_frame>Baseline to 24 or 52 weeks</time_frame>
    <description>Standardized asthma symptom survey</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Significant asthma exacerbations</measure>
    <time_frame>Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)</time_frame>
    <description>A protocol-defined asthma exacerbation was defined as worsening of asthma symptoms requiring treatment with systemic corticosteroids for 3 or more days; for patients receiving long-term oral corticosteroids, an exacerbation was a 20 mg or more increase in average daily dose of oral prednisone (or a similar dose of another systemic corticosteroid). The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 24 observation or 52-week treatment period in each treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Lung Function</measure>
    <time_frame>Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)</time_frame>
    <description>FEV1 % predicted pre- and post-bronchodilator FEV1 absolute (L) pre- and post-bronchodilator FVC % predicted pre- and post-bronchodilator FVC absolute (L) pre- and post-bronchodilator Bronchodilator response: % change in FEV1 after bronchodilator FEV1/FVC ratio: absolute and % predicted. Aggregated measure: significant vs non significant bronchodilator reversibility. Significant reversibility defined as greater than or equal to 12% and 200mL increase in FEV1 or FVC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Number of Puffs per Day of Beta Agonist Rescue Medication</measure>
    <time_frame>Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)</time_frame>
    <description>Number of inhalations per day averaged out over the study's duration Number of inhalations per night per month averaged out over the study's duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Adherence of Inhaled Corticosteroids</measure>
    <time_frame>Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)</time_frame>
    <description>Doses taken/doses prescribed average out over the study's duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Adherence of Biologics</measure>
    <time_frame>Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)</time_frame>
    <description>Doses taken/doses prescribed average out over the study's duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Steps Per Day</measure>
    <time_frame>Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)</time_frame>
    <description>Steps per day average out over study's duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Duration and Intensity of Exercise Per Day</measure>
    <time_frame>Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)</time_frame>
    <description>Minutes exercise per day average out over study's duration Minutes exercise/day x average heart rate during the exercise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Duration of Interrupted Sleep per Night</measure>
    <time_frame>Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)</time_frame>
    <description>Hours of uninterrupted sleep as recorded by Fitbit device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Number of Awakenings per Night</measure>
    <time_frame>Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)</time_frame>
    <description>Number of awakenings per night and/or early morning awakenings as a composite score, as recorded by Fitbit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Monthly Symptom Questionnaire Scores</measure>
    <time_frame>Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)</time_frame>
    <description>Each answer will be scored 1-10 points, depending on the answer, and added to create a survey score. Higher scores indicate poorer asthma control.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Asthma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult participants with uncontrolled, moderate-to-severe asthma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of uncontrolled or difficult-to-treat asthma, defined as 1 course of&#xD;
             systemic corticosteroids (e.g. oral prednisone) in the last 12 months&#xD;
&#xD;
          -  OR -&#xD;
&#xD;
          -  An asthma control test (ACT) score less than or equal to 19 despite regular use of&#xD;
             inhaled corticosteroids (ICS) therapy (at least 176 mcg of fluticasone/day or the&#xD;
             equivalent)&#xD;
&#xD;
          -  Participants will need access to a smartphone (As of January 2018, ~ 80% of U.S.&#xD;
             adults owned a smartphone (Mobile Fact Sheet, 2018))&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active smoking&#xD;
&#xD;
          -  Any significant comorbid conditions that could inadvertently interfere with study&#xD;
             results (i.e. any terminal illness, cancer, HIV, end-stage renal disease, congestive&#xD;
             heart failure, severe autoimmune disease or inflammatory bowel disease)&#xD;
&#xD;
          -  Conditions that require bursts of oral corticosteroids&#xD;
&#xD;
          -  Other significant lung diseases (cystic fibrosis, pulmonary hypertension, interstitial&#xD;
             lung disease, pulmonary fibrosis among others) to be determined by the investigators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Eileen Wang, MD, MPH</last_name>
    <phone>303-270-2796</phone>
    <email>wange@njhealth.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Jewish Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eileen Wang, MD, MPH</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>June 21, 2021</last_update_submitted>
  <last_update_submitted_qc>June 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Asthma</keyword>
  <keyword>Asthma control</keyword>
  <keyword>Biologics</keyword>
  <keyword>Biologic therapy</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Biologic therapies</keyword>
  <keyword>Mobile health</keyword>
  <keyword>Moderate-to-Severe</keyword>
  <keyword>Asthma exacerbation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04462224
org study id: HS-3476
nct id: NCT04462224
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Four novel biologic therapies (benralizumab, dupilumab, mepolizumab, reslizumab) have been
      recently approved for moderate-to-severe, eosinophilic or oral steroid-dependent asthma. The
      efficacy and safety of these therapies have been determined primarily by randomized clinical
      trials that compared annualized rates of significant asthma exacerbations (SAEs), lung
      function changes, and standardized symptom survey score changes in therapy-treated subjects
      in comparison to placebo matched controls. Yet, there is increasing interest to assess the
      efficacy, health benefits, and safety in medical therapies using real-world evidence (RWE).
      Further, home monitoring of asthma using mobile health (mHealth) technology may help
      scientists develop new and more sensitive indicators of asthma control that could improve
      clinical care. The hypothesis is that real world evidence, collected at home using several
      mobile health technologies, will help determine the efficacy, health benefits, and side
      effects of these therapies.

      Objectives

        1. Assess real-world evidence (RWE) indicators of worsening and improving asthma.
           Scientists will measure steps per day, duration and vigor of exercise per day, sleep
           quality, and the number of awakenings per night using Fitbit activity trackers.
           Scientists will measure symptoms using once-monthly custom survey delivered to
           participant smartphones via Twilio. Rescue medication use and adherence to maintenance
           medications may be measured using digital inhaler devices. Adherence to biologic use
           using HealthBeacon smart sharps containers may be measured. Measures collected will be
           correlated to patient-reported significant asthma exacerbations (SAEs), lung function
           (FEV1), and the asthma control test (ACT) collected in clinic every 3 months.

        2. Use RWE to determine responses to biologic therapies. Scientists will combine at-home
           and clinic data to determine responses to biologics.
observational model: Cohort
time perspective: Prospective
measure: Change from baseline in Asthma Control Test
time frame: Baseline to 24 or 52 weeks
description: Standardized asthma symptom survey
measure: Change From Baseline in Significant asthma exacerbations
time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
description: A protocol-defined asthma exacerbation was defined as worsening of asthma symptoms requiring treatment with systemic corticosteroids for 3 or more days; for patients receiving long-term oral corticosteroids, an exacerbation was a 20 mg or more increase in average daily dose of oral prednisone (or a similar dose of another systemic corticosteroid). The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 24 observation or 52-week treatment period in each treatment group.
measure: Change From Baseline in Lung Function
time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
description: FEV1 % predicted pre- and post-bronchodilator FEV1 absolute (L) pre- and post-bronchodilator FVC % predicted pre- and post-bronchodilator FVC absolute (L) pre- and post-bronchodilator Bronchodilator response: % change in FEV1 after bronchodilator FEV1/FVC ratio: absolute and % predicted. Aggregated measure: significant vs non significant bronchodilator reversibility. Significant reversibility defined as greater than or equal to 12% and 200mL increase in FEV1 or FVC
measure: Change From Baseline in Number of Puffs per Day of Beta Agonist Rescue Medication
time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
description: Number of inhalations per day averaged out over the study's duration Number of inhalations per night per month averaged out over the study's duration
measure: Change From Baseline in Adherence of Inhaled Corticosteroids
time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
description: Doses taken/doses prescribed average out over the study's duration
measure: Change From Baseline in Adherence of Biologics
time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
description: Doses taken/doses prescribed average out over the study's duration
measure: Change From Baseline in Steps Per Day
time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
description: Steps per day average out over study's duration
measure: Change From Baseline in Duration and Intensity of Exercise Per Day
time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
description: Minutes exercise per day average out over study's duration Minutes exercise/day x average heart rate during the exercise
measure: Change From Baseline in Duration of Interrupted Sleep per Night
time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
description: Hours of uninterrupted sleep as recorded by Fitbit device
measure: Change From Baseline in Number of Awakenings per Night
time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
description: Number of awakenings per night and/or early morning awakenings as a composite score, as recorded by Fitbit
measure: Change From Baseline in the Monthly Symptom Questionnaire Scores
time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
description: Each answer will be scored 1-10 points, depending on the answer, and added to create a survey score. Higher scores indicate poorer asthma control.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Eileen Wang, MD, MPH
phone: 303-270-2796
email: wange@njhealth.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Asthma