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/NCT06039943</url>
    </required_header>
    <id_info>
      <org_study_id>RKK7649</org_study_id>
      <nct_id>NCT06039943</nct_id>
    </id_info>
    <brief_title>Relationship Between Acoustic Breath Sounds and Spirometry</brief_title>
    <official_title>A Comparative Single Centre Study Assessing the Relationship Between Acoustic Breath Sounds as Measured by a Commercially Available Sound Recording Device Against Standard of Care (Spirometry) in the Assessment of Airflow Obstruction in Patients Who Plan to Undergo Spirometry Testing</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital Birmingham</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Respiri US</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital Birmingham</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to assess whether wheeze as assessed by a commercially&#xD;
        available wheeze monitor is comparable to lung function as measured during a spirometry test.&#xD;
        The main questions it aims to answer are whether measures of airflow obstruction (FEV1,&#xD;
        FEV1/FVC, PEF) correlate with wheeze score (Tw/Ttot%).&#xD;
  &#xD;
        Participants consenting to take part will undergo wheeze measurement prior to and during a&#xD;
        spirometry test and will be asked to complete a series of symptom questionnaires.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 13, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Wheeze score (Tw/Ttot%)</measure>
      <time_frame>Day 1</time_frame>
      <description>The average proportion of each breath that contained wheeze during a 30 second breath sound recording.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>FEV1/FVC</measure>
      <time_frame>Day 1</time_frame>
      <description>the ratio between forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>FEV1</measure>
      <time_frame>Day 1</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Asthma COPD</condition>
    <arm_group>
      <arm_group_label>All participants</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will undergo wheeze monitoring during tidal breathing prior to spirometry and during a spirometry test.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Wheeze measurement</intervention_name>
      <description>Acoustic breath sounds will be measured during tidal breathing prior to spirometry and during a spirometry attempt.</description>
      <arm_group_label>All participants</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Consenting adult (aged 18-95) University Hospitals Birmingham patient's attending the&#xD;
               Lung Function and Sleep Department (LF&amp;S) routinely as part of their standard clinical&#xD;
               management pathway for Lung Function testing that includes Spirometry assessments.&#xD;
  &#xD;
            -  All patients irrespective of condition will be approached to participate.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects who are contraindicated to perform spirometry on the day of testing&#xD;
  &#xD;
            -  Subjects who cannot speak or read English&#xD;
  &#xD;
            -  Patients accessing non-adult services&#xD;
  &#xD;
            -  Subjects who are unable or do not wish to consent&#xD;
  &#xD;
            -  Patients with known or suspected restrictive lung disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Richard Glover</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospitals Birmingham</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Brendan Cooper, PhD</last_name>
      <phone>01213713890</phone>
      <email>Brendan.Cooper@uhb.nhs.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Richard Glover</last_name>
      <phone>0121 424 7229</phone>
      <email>richard.glover@uhb.nhs.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospitals Birmingham NHS Foundation Trust</name>
        <address>
          <city>Birmingham</city>
          <state>West Midlands</state>
          <zip>B75 7RR</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Richard Glover</last_name>
        <phone>01214247229</phone>
        <email>Richard.glover@uhb.nhs.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Sounds</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>IPD will not be available to other researchers</ipd_description>
    </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/NCT06039943
  org study id: RKK7649
  nct id: NCT06039943
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to assess whether wheeze as assessed by a commercially
        available wheeze monitor is comparable to lung function as measured during a spirometry test.
        The main questions it aims to answer are whether measures of airflow obstruction (FEV1,
        FEV1/FVC, PEF) correlate with wheeze score (Tw/Ttot%).
  
        Participants consenting to take part will undergo wheeze measurement prior to and during a
        spirometry test and will be asked to complete a series of symptom questionnaires.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Wheeze score (Tw/Ttot%)
  time frame: Day 1
  description: The average proportion of each breath that contained wheeze during a 30 second breath sound recording.
  measure: FEV1/FVC
  time frame: Day 1
  description: the ratio between forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC)
  measure: FEV1
  time frame: Day 1
  arm group label: All participants
  arm group type: Experimental
  description: Participants will undergo wheeze monitoring during tidal breathing prior to spirometry and during a spirometry test.
  intervention type: Device
  intervention name: Wheeze measurement
  description: Acoustic breath sounds will be measured during tidal breathing prior to spirometry and during a spirometry attempt.
  arm group label: All participants
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Richard Glover
  role: Principal Investigator
  affiliation: University Hospitals Birmingham
  last name: Brendan Cooper, PhD
  phone: 01213713890
  email: Brendan.Cooper@uhb.nhs.uk
  last name: Richard Glover
  phone: 0121 424 7229
  email: richard.glover@uhb.nhs.uk
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Respiratory Sounds
  sharing ipd: No
  ipd description: IPD will not be available to other researchers