xml: <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/NCT06017739</url>
    </required_header>
    <id_info>
      <org_study_id>759del07/08/23</org_study_id>
      <nct_id>NCT06017739</nct_id>
    </id_info>
    <brief_title>Expiratory Flow Accelerator (Efa) vs Efa + High Flow in Chronic COPD and Bronchiectasis</brief_title>
    <official_title>Hypersecreting Patients (COPD And/or Bronchiectasic) Comparing 2 Technologies: Efa vs Efa + High Flow</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Azienda Socio Sanitaria Territoriale della Valle Olona</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Azienda Socio Sanitaria Territoriale della Valle Olona</source>
    <oversight_info>
      <has_dmc>Yes</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 aim of the study is to compare the efficacy of using EFA technology versus the&#xD;
        combination of EFA + high flow in hypersecretory patients COPD and bronchiectasis&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After being informed about the study and potential risks, all patients giving written&#xD;
        informed consent will undergo a 13-weeks trial period: 6 weeks of one technology (EFA / EFA+&#xD;
        HIGH FLOW), 1- wash out week and 6- weeks of the other technology in a cross over randomized&#xD;
        trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">January 18, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 18, 2024</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>Crossover Assignment</intervention_model>
      <intervention_model_description>the two arms of the study are:&#xD;
  EFA / EFA + High Flow&#xD;
  EFA + High Flow / EFA patients are randomly assigned to one of two groups</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cough Severity</measure>
      <time_frame>&quot;Day0&quot;, &quot;Week6&quot;, Week13&quot;</time_frame>
      <description>Visual Analogic Scale (0=not severe cough;10=very severe cough)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Expectoration Difficulty</measure>
      <time_frame>&quot;Day0&quot;, &quot;Week6&quot;, Week13&quot;</time_frame>
      <description>Visual Analogic Scale (0=not severe expectoration difficulty;10= very severe expectoration difficulty)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>FEV 1 (Forced Expiratory Volume)</measure>
      <time_frame>&quot;Day0&quot;, &quot;Week6&quot;, Week13&quot;</time_frame>
      <description>Airway obstruction index measured by spirometry</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exacerbations</measure>
      <time_frame>&quot;Day0&quot;, &quot;Week6&quot;, Week13&quot;</time_frame>
      <description>number of exacerbation/ year</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inspiratory Capacity</measure>
      <time_frame>&quot;Day0&quot;, &quot;Week6&quot;, Week13&quot;</time_frame>
      <description>air trapping index measured by spirometry</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6 minutes walking test</measure>
      <time_frame>&quot;Day0&quot;, &quot;Week6&quot;, Week13&quot;</time_frame>
      <description>index of cardiorespiratory function in activities of daily living</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Saint George Respiratory Questionnaire</measure>
      <time_frame>&quot;Day0&quot;, &quot;Week6&quot;, Week13&quot;</time_frame>
      <description>quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medical Research Council mMRC</measure>
      <time_frame>&quot;Day0&quot;, &quot;Week6&quot;, Week13&quot;</time_frame>
      <description>dyspnea perception (0 no dyspnea, 4 very important dyspnea)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SpO2 (Oxygen Saturation by Pulse Oximetry)</measure>
      <time_frame>&quot;Day0&quot;, &quot;Week6&quot;, Week13&quot;</time_frame>
      <description>blood oxygen saturation</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Copd</condition>
    <condition>Bronchiectasis Adult</condition>
    <arm_group>
      <arm_group_label>Expiratory Flow Accelerator</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients for 6 weeks use the Expiratory Flow Accelerator Technology</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Expiratory Flow Accelerator + HIGH FLOW Technology</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients for 6 weeks use the EFA technology and High Flow Technology</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Bronchial Clearance A</intervention_name>
      <description>EFA technology: the patient has to breathe at tidal volume by a mouthpiece at level 5 for half an hour twice a day.</description>
      <arm_group_label>Expiratory Flow Accelerator</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Bronchial Clearance B</intervention_name>
      <description>High Flow Technology: patient has to wear nasal cannula and breathe his nose for one hour twice a day. After he has to use EFA technology level 5 for half an hour twice a day.</description>
      <arm_group_label>Expiratory Flow Accelerator + HIGH FLOW Technology</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  COPD diagnosed by spirometry&#xD;
  &#xD;
            -  Bronchiectasis diagnosed by CT&#xD;
  &#xD;
            -  2 Exacerbation/year&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cystic Fibrosis&#xD;
  &#xD;
            -  OSAS&#xD;
  &#xD;
            -  Non Invasive Ventilation&#xD;
  &#xD;
            -  Ineffective Cough&#xD;
  &#xD;
            -  Exacerbation in progress&#xD;
  &#xD;
            -  Hemodynamic Instability&#xD;
  &#xD;
            -  severe heart failure&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>95 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marianna Messina</last_name>
      <role>Principal Investigator</role>
      <affiliation>ASST Valle Olona</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marianna Messina</last_name>
      <phone>+393356509059</phone>
      <email>annamessina.mm@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Marianna Messina</name>
        <address>
          <city>Fagnano Olona</city>
          <state>Varese</state>
          <zip>21054</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Marianna Messina</last_name>
        <phone>+393356509059</phone>
        <email>marianna.messina@asst-valleolona.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Azienda Socio Sanitaria Territoriale della Valle Olona</investigator_affiliation>
      <investigator_full_name>MARIANNA MESSINA</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>EFA</keyword>
    <keyword>HIGH FLOW</keyword>
    <keyword>BRONCHIECTASIS</keyword>
    <keyword>COPD</keyword>
    <keyword>HYPERSECRETION</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bronchiectasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017739
  org study id: 759del07/08/23
  nct id: NCT06017739
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to compare the efficacy of using EFA technology versus the
        combination of EFA + high flow in hypersecretory patients COPD and bronchiectasis
  After being informed about the study and potential risks, all patients giving written
        informed consent will undergo a 13-weeks trial period: 6 weeks of one technology (EFA / EFA+
        HIGH FLOW), 1- wash out week and 6- weeks of the other technology in a cross over randomized
        trial.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: the two arms of the study are:
  EFA / EFA + High Flow
  EFA + High Flow / EFA patients are randomly assigned to one of two groups
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Cough Severity
  time frame: "Day0", "Week6", Week13"
  description: Visual Analogic Scale (0=not severe cough;10=very severe cough)
  measure: Expectoration Difficulty
  time frame: "Day0", "Week6", Week13"
  description: Visual Analogic Scale (0=not severe expectoration difficulty;10= very severe expectoration difficulty)
  measure: FEV 1 (Forced Expiratory Volume)
  time frame: "Day0", "Week6", Week13"
  description: Airway obstruction index measured by spirometry
  measure: Exacerbations
  time frame: "Day0", "Week6", Week13"
  description: number of exacerbation/ year
  measure: Inspiratory Capacity
  time frame: "Day0", "Week6", Week13"
  description: air trapping index measured by spirometry
  measure: 6 minutes walking test
  time frame: "Day0", "Week6", Week13"
  description: index of cardiorespiratory function in activities of daily living
  measure: Saint George Respiratory Questionnaire
  time frame: "Day0", "Week6", Week13"
  description: quality of life
  measure: Medical Research Council mMRC
  time frame: "Day0", "Week6", Week13"
  description: dyspnea perception (0 no dyspnea, 4 very important dyspnea)
  measure: SpO2 (Oxygen Saturation by Pulse Oximetry)
  time frame: "Day0", "Week6", Week13"
  description: blood oxygen saturation
  arm group label: Expiratory Flow Accelerator
  arm group type: Experimental
  description: Patients for 6 weeks use the Expiratory Flow Accelerator Technology
  arm group label: Expiratory Flow Accelerator + HIGH FLOW Technology
  arm group type: Experimental
  description: Patients for 6 weeks use the EFA technology and High Flow Technology
  intervention type: Device
  intervention name: Bronchial Clearance A
  description: EFA technology: the patient has to breathe at tidal volume by a mouthpiece at level 5 for half an hour twice a day.
  arm group label: Expiratory Flow Accelerator
  intervention type: Device
  intervention name: Bronchial Clearance B
  description: High Flow Technology: patient has to wear nasal cannula and breathe his nose for one hour twice a day. After he has to use EFA technology level 5 for half an hour twice a day.
  arm group label: Expiratory Flow Accelerator + HIGH FLOW Technology
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 95 Years
  healthy volunteers: No
  last name: Marianna Messina
  role: Principal Investigator
  affiliation: ASST Valle Olona
  last name: Marianna Messina
  phone: +393356509059
  email: annamessina.mm@gmail.com
  facility: 
  contact: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Azienda Socio Sanitaria Territoriale della Valle Olona
  investigator full name: MARIANNA MESSINA
  investigator title: Principal Investigator
  mesh term: Bronchiectasis
  sharing ipd: No