<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/NCT03788395</url>
  </required_header>
  <id_info>
    <org_study_id>10/2018</org_study_id>
    <nct_id>NCT03788395</nct_id>
  </id_info>
  <brief_title>The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma</brief_title>
  <official_title>The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma</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>
      The management of chronic diseases requires a constant monitoring of treatment adherence, in&#xD;
      order to obtain an optimal disease control. However, this is often difficult to achieve,&#xD;
      especially in pediatric age.&#xD;
&#xD;
      In this sense, for asthmatic patients treated by Symbicort Turbohaler, &quot;AstraZeneca&quot;&#xD;
      developed the &quot;Turbo+&quot;, an electronic device attached to the Turbohaler, which allows to feel&#xD;
      whether the patient does the inhalation, and to register it on a specific application.&#xD;
&#xD;
      The present randomized trial aims to compare the treatment adherence between asthmatic&#xD;
      children/adolescents aged 6-17 years treated with Symbicort Turbohaler plus Turbo+ or&#xD;
      Symbicort Turbohaler without Turbo+.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">January 23, 2020</completion_date>
  <primary_completion_date type="Actual">January 23, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Medication Adherence Rating Scale (MARS)</measure>
    <time_frame>3 months</time_frame>
    <description>Change in the MARS score from baseline to the end of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Childhood Asthma Control Test (C-ACT)</measure>
    <time_frame>3 months</time_frame>
    <description>Change in the C-ACT score from baseline to the end of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Control Test (ACT)</measure>
    <time_frame>3 months</time_frame>
    <description>Change in the ACT score from baseline to the end of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Asthma Quality of Life Questionnaire (PAQLQ)</measure>
    <time_frame>3 months</time_frame>
    <description>Change in the PAQLQ score from baseline to the end of treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Symbicort Turbohaler plus Turbo+</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 asthmatic children</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Symbicort Turbohaler without Turbo+</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 asthmatic children</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Symbicort Turbohaler plus Turbo+</intervention_name>
    <description>Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) plus Turbo+ for three months.</description>
    <arm_group_label>Symbicort Turbohaler plus Turbo+</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Symbicort Turbohaler without Turbo+</intervention_name>
    <description>Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) without Turbo+ for three months.</description>
    <arm_group_label>Symbicort Turbohaler without Turbo+</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - uncontrolled mild or moderate persistent asthma;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute upper respiratory infections;&#xD;
&#xD;
          -  immunological or metabolic systemic disease;&#xD;
&#xD;
          -  major malformations of the upper airways;&#xD;
&#xD;
          -  active smokers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council</name>
      <address>
        <city>Palermo</city>
        <state>Sicily</state>
        <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>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</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>Coordinator of the group &quot;Clinical and Environmental Epidemiology of Pulmonary and Allergic Pediatric Diseases&quot;. 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Budesonide, Formoterol Fumarate Drug Combination</mesh_term>
  </intervention_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/NCT03788395
org study id: 10/2018
nct id: NCT03788395
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The management of chronic diseases requires a constant monitoring of treatment adherence, in
      order to obtain an optimal disease control. However, this is often difficult to achieve,
      especially in pediatric age.

      In this sense, for asthmatic patients treated by Symbicort Turbohaler, "AstraZeneca"
      developed the "Turbo+", an electronic device attached to the Turbohaler, which allows to feel
      whether the patient does the inhalation, and to register it on a specific application.

      The present randomized trial aims to compare the treatment adherence between asthmatic
      children/adolescents aged 6-17 years treated with Symbicort Turbohaler plus Turbo+ or
      Symbicort Turbohaler without Turbo+.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Medication Adherence Rating Scale (MARS)
time frame: 3 months
description: Change in the MARS score from baseline to the end of treatment
measure: Childhood Asthma Control Test (C-ACT)
time frame: 3 months
description: Change in the C-ACT score from baseline to the end of treatment
measure: Asthma Control Test (ACT)
time frame: 3 months
description: Change in the ACT score from baseline to the end of treatment
measure: Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
time frame: 3 months
description: Change in the PAQLQ score from baseline to the end of treatment
arm group label: Symbicort Turbohaler plus Turbo+
arm group type: Experimental
description: 10 asthmatic children
arm group label: Symbicort Turbohaler without Turbo+
arm group type: Active Comparator
description: 10 asthmatic children
intervention type: Device
intervention name: Symbicort Turbohaler plus Turbo+
description: Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) plus Turbo+ for three months.
arm group label: Symbicort Turbohaler plus Turbo+
intervention type: Drug
intervention name: Symbicort Turbohaler without Turbo+
description: Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) without Turbo+ for three months.
arm group label: Symbicort Turbohaler without Turbo+
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 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: Coordinator of the group "Clinical and Environmental Epidemiology of Pulmonary and Allergic Pediatric Diseases". Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
mesh term: Asthma
mesh term: Budesonide, Formoterol Fumarate Drug Combination