<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/NCT04467190</url>
  </required_header>
  <id_info>
    <org_study_id>PHT/2019/77</org_study_id>
    <nct_id>NCT04467190</nct_id>
  </id_info>
  <brief_title>Investigation of Inflammacheck to Measure Exhaled Breath Condensate Hydrogen Peroxide in Respiratory Conditions</brief_title>
  <acronym>VICTORY</acronym>
  <official_title>A Single Visit, Cross-sectional, Observational Study of EBC H2O2 Levels and Other Exhaled Breath Condensate Parameters as Measured by Inflammacheck, in People With a Variety of Respiratory Conditions and Volunteers With no Known Lung Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Portsmouth Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Portsmouth Hospitals NHS Trust</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>
      People with lung conditions can suffer significantly with their symptoms and often require&#xD;
      multiple trips to their GP or secondary care before a diagnosis is made. It can be difficult&#xD;
      to diagnose lung disease and to differentiate between different lung conditions, so many&#xD;
      people may be misdiagnosed or incorrectly not given a diagnosis. The tests currently used to&#xD;
      diagnose lung diseases can be difficult or uncomfortable to do, especially if the person is&#xD;
      experiencing lots of symptoms, and therefore can give poor or unreliable results.A new quick&#xD;
      and easy to perform test is needed that can differentiate between various lung conditions and&#xD;
      people with no lung disease, that can be performed in primary and secondary care with&#xD;
      immediate results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lung disease is one of the largest contributors to morbidity and mortality in the UK, with&#xD;
      20% of the population diagnosed with, or receiving treatment for a respiratory condition.&#xD;
&#xD;
      Methods of diagnosis are still convoluted and can be difficult to perform, or very costly in&#xD;
      patient and clinician time. Some diagnostic tests only look for a specific type of&#xD;
      inflammation (e.g. Fractional exhaled Nitric Oxide) and so can overlook other causes. It can&#xD;
      be hard to differentiate between different conditions, and as a result there are thousands of&#xD;
      people in the UK who have undiagnosed or misdiagnosed respiratory disease.&#xD;
&#xD;
      Measurement of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) is performed during&#xD;
      normal tidal breathing, and is well tolerated even in patients with severe airways&#xD;
      obstruction and those unable to perform a consistent controlled exhalation. It is also not&#xD;
      limited to inflammatory cell specific inflammation.&#xD;
&#xD;
      In studies using the previous version of the Inflammacheck™ device, significant differences&#xD;
      have been demonstrated between levels of H2O2 in people with COPD, asthma, ILD and lung&#xD;
      cancer compared to healthy controls. These studies have been instrumental in the continued&#xD;
      improvement of the device, to ensure that the participant has the best experience, and&#xD;
      simplify the procedure, so that the H2O2 result can be obtained with a single test in under 3&#xD;
      minutes.&#xD;
&#xD;
      Although the primary result of the Inflammacheck™ device is EBC H2O2, it is now also able to&#xD;
      measure clinically important parameters including breath temperature, humidity, Carbon&#xD;
      Dioxide waveforms, and intra-thoracic pressure changes. These parameters, in combination with&#xD;
      the EBC H2O2 may be able to be used together to identify differences between people with&#xD;
      various respiratory diseases and healthy volunteers. The device has also been improved based&#xD;
      on the participant feedback, to ensure that it is user friendly and comfortable.&#xD;
&#xD;
      The investigators need to determine whether the parameters (H2O2, humidity, temperature,&#xD;
      exhaled CO2 waveform and intra-thoracic pressure), as measured by 'Inflammacheck™' can either&#xD;
      alone or in combination differentiate asthma, COPD, lung cancer, ILD, breathing pattern&#xD;
      disorder, bronchiectasis and pneumonia from other each other and from healthy controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2019</start_date>
  <completion_date type="Actual">October 13, 2022</completion_date>
  <primary_completion_date type="Actual">October 13, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To measure the levels of H2O2 in EBC in patients with a range of commonly occurring respiratory conditions</measure>
    <time_frame>immediately after the procedure (breathing into device)</time_frame>
    <description>levels of H2O2 in Exhaled Breath Condensate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To measure humidity levels in EBC in patients with a range of commonly occurring respiratory conditions</measure>
    <time_frame>immediately after the procedure (breathing into device)</time_frame>
    <description>level of humidity in breath in Exhaled Breath Condensate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To measure the breath temperature in EBC in patients with a range of commonly occurring respiratory conditions</measure>
    <time_frame>immediately after the procedure (breathing into device)</time_frame>
    <description>temperature of breath in Exhaled Breath Condensate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To measure CO2 waveform in patients with a range of commonly occurring respiratory conditions</measure>
    <time_frame>immediately after the procedure (breathing into device)</time_frame>
    <description>exhaled CO2 waveform</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To measure intrathoracic pressure in patients with a range of commonly occurring respiratory conditions</measure>
    <time_frame>immediately after the procedure (breathing into device)</time_frame>
    <description>intrathoracic pressure</description>
  </primary_outcome>
  <enrollment type="Actual">425</enrollment>
  <condition>Respiratory Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with respiratory disease or healthy controls as defined in the inclusion and&#xD;
        exclusion criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female, aged ≥16 years&#xD;
&#xD;
          -  A confirmed, clinician made diagnosis of the following (supported by standard accepted&#xD;
             diagnostic criteria):&#xD;
&#xD;
          -  Asthma with a ≤10 pack year smoking history (confirmed by spirometry and/or airway&#xD;
             inflammation and function tests)&#xD;
&#xD;
          -  COPD (confirmed by spirometry)&#xD;
&#xD;
          -  Bronchiectasis (confirmed by CT scan)&#xD;
&#xD;
          -  Interstitial Lung Disease (confirmed by CT scan and MDT/specialist consensus)&#xD;
&#xD;
          -  has or is eventually proven to have a histological OR radiological and MDT confirmed&#xD;
             diagnosis of primary lung cancer, and not yet started treatment for this&#xD;
&#xD;
          -  current pneumonia (confirmed by chest imaging)&#xD;
&#xD;
          -  Breathing Pattern Disorder, with no other significant respiratory co-morbidity&#xD;
             (specialist confirmed)&#xD;
&#xD;
          -  Healthy controls (defined as no current clinical diagnosis of, or be receiving&#xD;
             treatment for, a lung or other significant medical disorder).&#xD;
&#xD;
          -  Willing and able to give informed consent for participation in the study.&#xD;
&#xD;
          -  In a stable state (at least 4 weeks after treatment of an exacerbation of their&#xD;
             respiratory disease)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Existing co-morbidities that may prevent them from performing spirometry, for those&#xD;
             with asthma, COPD, or healthy controls, with no spirometry in the previous 12 months&#xD;
             (at the discretion of the clinical investigator).&#xD;
&#xD;
          -  Unable to comprehend the study, provide informed consent, and unable to perform any of&#xD;
             the study procedures.&#xD;
&#xD;
          -  Requirement of supplemental oxygen (pneumonia participants only)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Portsmouth Hospitals NHS Trust</name>
      <address>
        <city>Portsmouth</city>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>February 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 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 Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</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/NCT04467190
org study id: PHT/2019/77
nct id: NCT04467190
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
People with lung conditions can suffer significantly with their symptoms and often require
      multiple trips to their GP or secondary care before a diagnosis is made. It can be difficult
      to diagnose lung disease and to differentiate between different lung conditions, so many
      people may be misdiagnosed or incorrectly not given a diagnosis. The tests currently used to
      diagnose lung diseases can be difficult or uncomfortable to do, especially if the person is
      experiencing lots of symptoms, and therefore can give poor or unreliable results.A new quick
      and easy to perform test is needed that can differentiate between various lung conditions and
      people with no lung disease, that can be performed in primary and secondary care with
      immediate results.
Lung disease is one of the largest contributors to morbidity and mortality in the UK, with
      20% of the population diagnosed with, or receiving treatment for a respiratory condition.

      Methods of diagnosis are still convoluted and can be difficult to perform, or very costly in
      patient and clinician time. Some diagnostic tests only look for a specific type of
      inflammation (e.g. Fractional exhaled Nitric Oxide) and so can overlook other causes. It can
      be hard to differentiate between different conditions, and as a result there are thousands of
      people in the UK who have undiagnosed or misdiagnosed respiratory disease.

      Measurement of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) is performed during
      normal tidal breathing, and is well tolerated even in patients with severe airways
      obstruction and those unable to perform a consistent controlled exhalation. It is also not
      limited to inflammatory cell specific inflammation.

      In studies using the previous version of the Inflammacheck™ device, significant differences
      have been demonstrated between levels of H2O2 in people with COPD, asthma, ILD and lung
      cancer compared to healthy controls. These studies have been instrumental in the continued
      improvement of the device, to ensure that the participant has the best experience, and
      simplify the procedure, so that the H2O2 result can be obtained with a single test in under 3
      minutes.

      Although the primary result of the Inflammacheck™ device is EBC H2O2, it is now also able to
      measure clinically important parameters including breath temperature, humidity, Carbon
      Dioxide waveforms, and intra-thoracic pressure changes. These parameters, in combination with
      the EBC H2O2 may be able to be used together to identify differences between people with
      various respiratory diseases and healthy volunteers. The device has also been improved based
      on the participant feedback, to ensure that it is user friendly and comfortable.

      The investigators need to determine whether the parameters (H2O2, humidity, temperature,
      exhaled CO2 waveform and intra-thoracic pressure), as measured by 'Inflammacheck™' can either
      alone or in combination differentiate asthma, COPD, lung cancer, ILD, breathing pattern
      disorder, bronchiectasis and pneumonia from other each other and from healthy controls.
observational model: Case-Crossover
time perspective: Prospective
measure: To measure the levels of H2O2 in EBC in patients with a range of commonly occurring respiratory conditions
time frame: immediately after the procedure (breathing into device)
description: levels of H2O2 in Exhaled Breath Condensate
measure: To measure humidity levels in EBC in patients with a range of commonly occurring respiratory conditions
time frame: immediately after the procedure (breathing into device)
description: level of humidity in breath in Exhaled Breath Condensate
measure: To measure the breath temperature in EBC in patients with a range of commonly occurring respiratory conditions
time frame: immediately after the procedure (breathing into device)
description: temperature of breath in Exhaled Breath Condensate
measure: To measure CO2 waveform in patients with a range of commonly occurring respiratory conditions
time frame: immediately after the procedure (breathing into device)
description: exhaled CO2 waveform
measure: To measure intrathoracic pressure in patients with a range of commonly occurring respiratory conditions
time frame: immediately after the procedure (breathing into device)
description: intrathoracic pressure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
sharing ipd: No