<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/NCT04504838</url>
  </required_header>
  <id_info>
    <org_study_id>PHT/2019/26</org_study_id>
    <secondary_id>37872</secondary_id>
    <nct_id>NCT04504838</nct_id>
  </id_info>
  <brief_title>The Asthma Breathing Record Study</brief_title>
  <acronym>ABRS</acronym>
  <official_title>A Longitudinal, Observational Study to Explore the Tidal Breathing Carbon Dioxide (TBCO2) Waveform, Measured Using the N-Tidal C Device, in Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TidalSense</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Portsmouth Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>TidalSense</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 study involves a new device, called 'N-Tidal C', which uses a method that has the&#xD;
      potential to predict when asthma attacks are about to happen. The device works by accurately&#xD;
      measuring an individual's exhaled CO2 waveform. A person has to breathe in and out through&#xD;
      the mouthpiece at their normal relaxed rate of breathing. It does not need any extra effort&#xD;
      and therefore has considerable benefits over current breathing tests which require&#xD;
      significant patient effort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      People with more severe asthma suffer from frequent asthma attacks that require regular&#xD;
      hospital admissions. These attacks are difficult to predict and can devastate the lives of&#xD;
      patients. A new tool is needed that can help to predict when an asthma attack is going to&#xD;
      happen. This would help people recognise an attack earlier and allow treatment to be started&#xD;
      sooner. This study will evaluate a new breathing monitor, to see whether it can detect asthma&#xD;
      attacks. The study tests a new device, called 'N-Tidal C', which uses a method that has the&#xD;
      potential to predict when attacks are about to happen. The investigators have found that&#xD;
      people with asthma breathe out a gas, called carbon dioxide (CO2), in a different way to&#xD;
      healthy people. The pattern of breathing out CO2 (the waveform) changes further when patients&#xD;
      are having an attack of their disease. If patients could monitor their CO2, they may&#xD;
      recognise when their asthma is getting worse, and take earlier action to avoid attacks&#xD;
      getting out of hand and going to hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 11, 2020</start_date>
  <completion_date type="Actual">January 31, 2022</completion_date>
  <primary_completion_date type="Actual">January 20, 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>Tidal Breathing Carbon Dioxide (TBCO2) breath records measured by the N-Tidal C data collector device.</measure>
    <time_frame>From baseline until study completion, up to 12 months.</time_frame>
    <description>To collect Tidal Breathing Carbon Dioxide (TBCO2) breath records, twice daily per participant, which will be correlated to patient reported outcomes and clinical assessments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease Control in asthma patients</measure>
    <time_frame>From baseline until study completion, up to 12 months.</time_frame>
    <description>Asthma Control Questionnaire (ACQ) (0= no impairment 6 = maximum impairment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>From baseline until study completion, up to 12 months.</time_frame>
    <description>Asthma Quality of Life Questionnaire (AQLQ) 7 = not impaired at all - 1 = severely impaired</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability and Acceptability of the device</measure>
    <time_frame>From baseline until study completion, up to 12 months.</time_frame>
    <description>Visual Analogue Scale (VAS) (7=easy to use - 28=difficult to use)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on work activity of the device within asthma population</measure>
    <time_frame>From baseline until study completion, up to 12 months.</time_frame>
    <description>Work Productivity and Activity Impairment Questionnaire (WPAI): Asthma (1=employed - 5= health affected productivity while working)</description>
  </secondary_outcome>
  <enrollment type="Actual">124</enrollment>
  <condition>Asthma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with poorly controlled asthma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or Female, aged ≥7 years.&#xD;
&#xD;
          2. Confirmed clinician diagnosis of asthma by examination of medical records, and based&#xD;
             on accepted national and/or international criteria e.g. BTS/SIGN, or GINA.&#xD;
&#xD;
          3. Moderate or Severe asthma (defined as BTS stage 2-5)&#xD;
&#xD;
          4. Poorly controlled asthma (defined as an ACQ score of ≥1)&#xD;
&#xD;
          5. Exacerbation prone asthma (defined as at least 1 asthma exacerbation requiring oral&#xD;
             corticosteroid treatment in the last 12 months).&#xD;
&#xD;
          6. Providing written informed consent, or parental/guardian consent and participant&#xD;
             assent in the case of a child&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to understand or comply with study procedures and/or inability to give fully&#xD;
             informed consent.&#xD;
&#xD;
          2. Known other lung, chest wall, neuromuscular, cardiac or other comorbidity or&#xD;
             abnormality that would affect spirometry and/or other measures of lung function or&#xD;
             TBCO2 measurements (including Breathing Pattern Disorder or Chronic Obstructive&#xD;
             Pulmonary Disease).&#xD;
&#xD;
          3. Smokers (current or ex-smokers) with a &gt;10 pack year history.&#xD;
&#xD;
          4. In the opinion of the clinical investigator, the participant would have difficulty&#xD;
             completing the study procedures consistently (for example, difficulty holding the&#xD;
             device, or long periods of absence/travel) throughout the study period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anoop Chauhan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Portsmouth Hospitals NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Portsmouth Hospitals NHS Trust</name>
      <address>
        <city>Portsmouth</city>
        <state>Hampshire</state>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>April 8, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>June 16, 2022</last_update_submitted>
  <last_update_submitted_qc>June 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2022</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>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04504838
org study id: PHT/2019/26
secondary id: 37872
nct id: NCT04504838
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study involves a new device, called 'N-Tidal C', which uses a method that has the
      potential to predict when asthma attacks are about to happen. The device works by accurately
      measuring an individual's exhaled CO2 waveform. A person has to breathe in and out through
      the mouthpiece at their normal relaxed rate of breathing. It does not need any extra effort
      and therefore has considerable benefits over current breathing tests which require
      significant patient effort.
People with more severe asthma suffer from frequent asthma attacks that require regular
      hospital admissions. These attacks are difficult to predict and can devastate the lives of
      patients. A new tool is needed that can help to predict when an asthma attack is going to
      happen. This would help people recognise an attack earlier and allow treatment to be started
      sooner. This study will evaluate a new breathing monitor, to see whether it can detect asthma
      attacks. The study tests a new device, called 'N-Tidal C', which uses a method that has the
      potential to predict when attacks are about to happen. The investigators have found that
      people with asthma breathe out a gas, called carbon dioxide (CO2), in a different way to
      healthy people. The pattern of breathing out CO2 (the waveform) changes further when patients
      are having an attack of their disease. If patients could monitor their CO2, they may
      recognise when their asthma is getting worse, and take earlier action to avoid attacks
      getting out of hand and going to hospital.
observational model: Cohort
time perspective: Prospective
measure: Tidal Breathing Carbon Dioxide (TBCO2) breath records measured by the N-Tidal C data collector device.
time frame: From baseline until study completion, up to 12 months.
description: To collect Tidal Breathing Carbon Dioxide (TBCO2) breath records, twice daily per participant, which will be correlated to patient reported outcomes and clinical assessments.
measure: Disease Control in asthma patients
time frame: From baseline until study completion, up to 12 months.
description: Asthma Control Questionnaire (ACQ) (0= no impairment 6 = maximum impairment)
measure: Quality of Life
time frame: From baseline until study completion, up to 12 months.
description: Asthma Quality of Life Questionnaire (AQLQ) 7 = not impaired at all - 1 = severely impaired
measure: Usability and Acceptability of the device
time frame: From baseline until study completion, up to 12 months.
description: Visual Analogue Scale (VAS) (7=easy to use - 28=difficult to use)
measure: Impact on work activity of the device within asthma population
time frame: From baseline until study completion, up to 12 months.
description: Work Productivity and Activity Impairment Questionnaire (WPAI): Asthma (1=employed - 5= health affected productivity while working)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: No
last name: Anoop Chauhan
role: Principal Investigator
affiliation: Portsmouth Hospitals NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No