<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/NCT03273933</url>
  </required_header>
  <id_info>
    <org_study_id>7/2017_B</org_study_id>
    <nct_id>NCT03273933</nct_id>
  </id_info>
  <brief_title>DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices</brief_title>
  <acronym>DragONE</acronym>
  <official_title>DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto per la Ricerca e l'Innovazione Biomedica</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto per la Ricerca e l'Innovazione Biomedica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized clinical trial to assess acquisition and maintenance of paediatric asthma control&#xD;
      through innovative devices supporting usual care. In the first study arm, a new application&#xD;
      (DragONE) for iOS and Android will be only used for patient monitoring. In the second study&#xD;
      arm, a small portable device (SmartONE) will also be connected to the DragONE APP, for daily&#xD;
      assessment of the peak expiratory flow (PEF). The study duration is 12 weeks. The main&#xD;
      outcome of the study is the Childhood Asthma Control Test (C-ACT) score, assessed once every&#xD;
      4 weeks for 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2018</start_date>
  <completion_date type="Actual">February 26, 2020</completion_date>
  <primary_completion_date type="Actual">February 26, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acquisition and maintenance of the control status</measure>
    <time_frame>Once every 4 weeks, for 12 weeks</time_frame>
    <description>mean C-ACT score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life in asthma children</measure>
    <time_frame>12 weeks</time_frame>
    <description>PAQLQ score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to asthma treatment</measure>
    <time_frame>12 weeks</time_frame>
    <description>MARS score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung function: FEV1</measure>
    <time_frame>12 weeks</time_frame>
    <description>Forced expiratory volume in the first second</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung function: FVC</measure>
    <time_frame>12 weeks</time_frame>
    <description>Forced vital capacity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung function: FEF 25-75</measure>
    <time_frame>12 weeks</time_frame>
    <description>Forced expiratory flow at 25-75%</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>10 children with DragONE only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>10 children with DragONE and SmartOne</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DragONE</intervention_name>
    <description>The DragONE application for iOS and Android, developed in collaboration with the Institute for Educational Technologies of the National Research Council of Palermo, allow children to daily fill electronically the C-ACT questionnaire and the symptom diary card.</description>
    <arm_group_label>10 children with DragONE and SmartOne</arm_group_label>
    <arm_group_label>10 children with DragONE only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SmartOne</intervention_name>
    <description>A little portable spirometer connected to DragONE allows daily PEF monitoring.</description>
    <arm_group_label>10 children with DragONE and SmartOne</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of moderate persistent asthma&#xD;
&#xD;
          -  Uncontrolled symptoms (C-ACT≤ 19)&#xD;
&#xD;
          -  Treated for at least 3 months&#xD;
&#xD;
          -  FEV1 between 60% and 90% of predicted value&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptoms of acute respiratory infection&#xD;
&#xD;
          -  Immunological or metabolic systemic disease&#xD;
&#xD;
          -  Major malformations of the upper airways&#xD;
&#xD;
          -  Active smoker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo</name>
      <address>
        <city>Palermo</city>
        <zip>90146</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto per la Ricerca e l'Innovazione Biomedica</investigator_affiliation>
    <investigator_full_name>Stefania La Grutta, MD</investigator_full_name>
    <investigator_title>Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.</investigator_title>
  </responsible_party>
  <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/NCT03273933
org study id: 7/2017_B
nct id: NCT03273933
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Randomized clinical trial to assess acquisition and maintenance of paediatric asthma control
      through innovative devices supporting usual care. In the first study arm, a new application
      (DragONE) for iOS and Android will be only used for patient monitoring. In the second study
      arm, a small portable device (SmartONE) will also be connected to the DragONE APP, for daily
      assessment of the peak expiratory flow (PEF). The study duration is 12 weeks. The main
      outcome of the study is the Childhood Asthma Control Test (C-ACT) score, assessed once every
      4 weeks for 12 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Acquisition and maintenance of the control status
time frame: Once every 4 weeks, for 12 weeks
description: mean C-ACT score
measure: Quality of life in asthma children
time frame: 12 weeks
description: PAQLQ score
measure: Adherence to asthma treatment
time frame: 12 weeks
description: MARS score
measure: Lung function: FEV1
time frame: 12 weeks
description: Forced expiratory volume in the first second
measure: Lung function: FVC
time frame: 12 weeks
description: Forced vital capacity
measure: Lung function: FEF 25-75
time frame: 12 weeks
description: Forced expiratory flow at 25-75%
arm group label: 10 children with DragONE only
arm group type: Active Comparator
arm group label: 10 children with DragONE and SmartOne
arm group type: Experimental
intervention type: Device
intervention name: DragONE
description: The DragONE application for iOS and Android, developed in collaboration with the Institute for Educational Technologies of the National Research Council of Palermo, allow children to daily fill electronically the C-ACT questionnaire and the symptom diary card.
arm group label: 10 children with DragONE and SmartOne
arm group label: 10 children with DragONE only
intervention type: Device
intervention name: SmartOne
description: A little portable spirometer connected to DragONE allows daily PEF monitoring.
arm group label: 10 children with DragONE and SmartOne
criteria: 
gender: All
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Istituto per la Ricerca e l'Innovazione Biomedica
investigator full name: Stefania La Grutta, MD
investigator title: Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
mesh term: Asthma