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/NCT06008145</url>
    </required_header>
    <id_info>
      <org_study_id>23RM005</org_study_id>
      <nct_id>NCT06008145</nct_id>
    </id_info>
    <brief_title>COPD Case Finding In Nottingham and District: C-FIND COPD A Pilot Study</brief_title>
    <acronym>C-FIND</acronym>
    <official_title>COPD Case Finding In Nottingham and District: C-FIND COPD A Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nottingham University Hospitals NHS Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Nottingham</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Nottingham University 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>
        The Targeted Lung Health Check (TLHC) is currently being rolled out in many regions of the&#xD;
        United Kingdom and has just started in Nottingham. The same cohort of people are also at high&#xD;
        risk for Chronic Obstructive Pulmonary Disease (COPD), a lung condition often caused by&#xD;
        smoking and leading to breathlessness and cough. This study aims to provide pilot evidence of&#xD;
        the role of breathing tests in those who have had a Computerised Tomography (CT) scan, in&#xD;
        order to early diagnose COPD. Currently, at diagnosis, many patients have lost 30-40% of lung&#xD;
        function already, which is not reversible.&#xD;
  &#xD;
        This study will use the Nottingham University Hospitals Trust Mobile Research Unit. The unit&#xD;
        will follow the CT scanner route 2-3 weeks later, and people who have had a CT scan will be&#xD;
        invited for breathing tests. Participants will also collect further information on potential&#xD;
        treatment options for people diagnosed with COPD earlier -including smoking cessation,&#xD;
        symptom management and general health advice (vaccinations, diet, activity and managing&#xD;
        infections). There is also an optional blood test.&#xD;
  &#xD;
        The study aims are to determine the uptake and acceptability of breathing tests in patients&#xD;
        at high risk of COPD, and if a community based approach co-locating with TLHC can increase&#xD;
        uptake.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Ever smokers, aged between 55 to 74 years are invited for a telephone risk assessment. Those&#xD;
        who are high risk (based on validated lung cancer risk scores, which incorporate a number of&#xD;
        variables, including age and smoking intensity) are then sequentially invited for a CT scan&#xD;
        in a certain locality of Nottingham as part of the TLHC. As the programme is introduced the&#xD;
        number of invites per month will increase from 500 to 1800. It is anticipated that 40 to 45%&#xD;
        of those will take up the invite and have a CT scan. At the time of their CT scan all smokers&#xD;
        will be offered smoking cessation.&#xD;
  &#xD;
        The clinical pathway incorporates that the CT scans will be reported by Heart Lung Health ,&#xD;
        with responsible clinician - Dr O'Dowd. Patients identified as having cancer or high&#xD;
        likelihood will be approached and commenced on a cancer diagnostic pathway. This study&#xD;
        addresses people who are not entering this pathway.&#xD;
  &#xD;
        Two-three weeks after the CT scan, the clinical team will invite people to attend for a&#xD;
        research study to assess lung health if they have symptoms of cough, breathlessness or 2 or&#xD;
        more courses antibiotics in the last 15 months. No further reminder will be sent. The&#xD;
        investigators will not excluding people with COPD already and will not turn away high-risk&#xD;
        people who self-present even if not had a CT.&#xD;
  &#xD;
        The invite will include mention of when the mobile unit is open and in their locality, what&#xD;
        the visit consists of and that participants are free to come down at a convenient time. A&#xD;
        telephone number and e-mail will be provided if somebody contacts the investigators and would&#xD;
        prefer to be seen in a standard research unit - an appointment will be provided. The letter&#xD;
        will remind participants that this cannot cover broader medical issues or emergencies, where&#xD;
        usual clinical advice should be sought.&#xD;
  &#xD;
        Following informed consent, the following will occur by trained clinical research&#xD;
        practitioners and under the support of a research nurse.&#xD;
  &#xD;
          -  Questionnaires:&#xD;
  &#xD;
               -  Symptom scores and information on tobacco smoking / other exposures, past medical&#xD;
                  history, medication&#xD;
  &#xD;
               -  COPD Assessment Test (CAT) Quality of Life score&#xD;
  &#xD;
               -  Medical Research Council (MRC) breathlessness score&#xD;
  &#xD;
               -  Exacerbation frequency&#xD;
  &#xD;
               -  EQ5D - Health Status&#xD;
  &#xD;
          -  Observations:&#xD;
  &#xD;
               -  Oximetry for heart rate and oxygen saturations&#xD;
  &#xD;
               -  Height&#xD;
  &#xD;
               -  Weight&#xD;
  &#xD;
               -  Blood pressure&#xD;
  &#xD;
          -  Postbronchodilator spirometry - salbutamol delivered by trained staff.&#xD;
  &#xD;
          -  Forced Oscillation Technique (FOT)- a non-clinically used breathing test but might have&#xD;
             a role in early detection.&#xD;
  &#xD;
          -  Approach for future research and store research data obtained here / review medical&#xD;
             records for future medicines.&#xD;
  &#xD;
          -  Invite to provide a blood sample and nasal swab for early markers of COPD - optional and&#xD;
             currently of no clinical relevance.&#xD;
  &#xD;
        Those with clinical evidence of COPD will be given information by a registered Health Care&#xD;
        professional trained to do so on:&#xD;
  &#xD;
          -  COPD and what it is.&#xD;
  &#xD;
          -  Need for immunisations.&#xD;
  &#xD;
          -  General health education, self-management and tobacco cessation where indicated.&#xD;
  &#xD;
          -  Whether further review at the surgery is required.&#xD;
  &#xD;
          -  Clinical information will be fed back to primary care surgery and uploaded onto medical&#xD;
             health records, such as SystemOne. The participant will have consented to this.&#xD;
  &#xD;
        The investigators will seek feedback from participants and subsequently from the primary care&#xD;
        clinicians.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2024</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of people who take up the invite to attend for a C-FIND visit.</measure>
      <time_frame>1.5 years</time_frame>
      <description>0-100%</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion diagnosed with COPD</measure>
      <time_frame>1.5 years</time_frame>
      <description>0-100%</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CAT COPD Quality of Life Score</measure>
      <time_frame>1 day</time_frame>
      <description>Questionnaire. Wellbeing and daily life questions, scored 0-40 points, lower better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MRC breathlessness score</measure>
      <time_frame>1 day</time_frame>
      <description>Questionnaire, self reported breathlessness grade 1-5, lower better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exacerbation Frequency</measure>
      <time_frame>1 day</time_frame>
      <description>0-12/year</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D-5L - Health Status</measure>
      <time_frame>1 day</time_frame>
      <description>Questionnaire. Self reported health scale 0-100. Greater better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oximetry for oxygen saturations</measure>
      <time_frame>1 day</time_frame>
      <description>75-100% Oxygen saturation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Height</measure>
      <time_frame>1 day</time_frame>
      <description>Participant height in metres - range 1.2-2.0m</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>1 day</time_frame>
      <description>participant weight in Kg - range 35-180Kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BMI</measure>
      <time_frame>1 day</time_frame>
      <description>12-60g/m2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure diastolic</measure>
      <time_frame>1 day</time_frame>
      <description>40-120mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post bronchodilator Spirometry</measure>
      <time_frame>1 day</time_frame>
      <description>Forced Expired Volume (FEV)% - range 10-140% predicted</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FOT-R (Resistance)</measure>
      <time_frame>1 day</time_frame>
      <description>cmH2O.s/l</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FOT-X (reactance)</measure>
      <time_frame>1 day</time_frame>
      <description>cmH2O.s/l</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FOT-AX (area of reactance)</measure>
      <time_frame>1 day</time_frame>
      <description>cmH2O/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FOT-Fres (resonant Frequency)</measure>
      <time_frame>1 day</time_frame>
      <description>Hz</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure -systolic</measure>
      <time_frame>1 day</time_frame>
      <description>75-230mmHg</description>
    </secondary_outcome>
    <enrollment type="Anticipated">600</enrollment>
    <condition>COPD</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        whole blood and nasal brush&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          The Targeted Lung Health Check (THLC) cohort are a population that are at high risk for&#xD;
          COPD, a lung condition often caused by smoking. This same population will be invited to&#xD;
          undertake breathing test in order to early diagnose COPD.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Smoking history - either compatible with TLHC (current or ex-smoker who are high risk&#xD;
               based on lung cancer risk scores) or if self-presenting &gt;10 pack years (current or ex)&#xD;
  &#xD;
            -  Able to provide full informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  People currently undergoing active investigation or treatment for cancer&#xD;
  &#xD;
            -  Unable to provide informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Charlotte Bolton, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Nottingham University Hospitals NHS Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Joanne Porte, MSc</last_name>
      <phone>0115 8231723</phone>
      <email>Joanne.Porte@nottingham.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Charlotte Bolton, MD</last_name>
      <email>Charlotte.Bolton@nottingham.ac.uk</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>COPD</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    </condition_browse>
    <!-- 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/NCT06008145
  org study id: 23RM005
  nct id: NCT06008145
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The Targeted Lung Health Check (TLHC) is currently being rolled out in many regions of the
        United Kingdom and has just started in Nottingham. The same cohort of people are also at high
        risk for Chronic Obstructive Pulmonary Disease (COPD), a lung condition often caused by
        smoking and leading to breathlessness and cough. This study aims to provide pilot evidence of
        the role of breathing tests in those who have had a Computerised Tomography (CT) scan, in
        order to early diagnose COPD. Currently, at diagnosis, many patients have lost 30-40% of lung
        function already, which is not reversible.
  
        This study will use the Nottingham University Hospitals Trust Mobile Research Unit. The unit
        will follow the CT scanner route 2-3 weeks later, and people who have had a CT scan will be
        invited for breathing tests. Participants will also collect further information on potential
        treatment options for people diagnosed with COPD earlier -including smoking cessation,
        symptom management and general health advice (vaccinations, diet, activity and managing
        infections). There is also an optional blood test.
  
        The study aims are to determine the uptake and acceptability of breathing tests in patients
        at high risk of COPD, and if a community based approach co-locating with TLHC can increase
        uptake.
  Ever smokers, aged between 55 to 74 years are invited for a telephone risk assessment. Those
        who are high risk (based on validated lung cancer risk scores, which incorporate a number of
        variables, including age and smoking intensity) are then sequentially invited for a CT scan
        in a certain locality of Nottingham as part of the TLHC. As the programme is introduced the
        number of invites per month will increase from 500 to 1800. It is anticipated that 40 to 45%
        of those will take up the invite and have a CT scan. At the time of their CT scan all smokers
        will be offered smoking cessation.
  
        The clinical pathway incorporates that the CT scans will be reported by Heart Lung Health ,
        with responsible clinician - Dr O'Dowd. Patients identified as having cancer or high
        likelihood will be approached and commenced on a cancer diagnostic pathway. This study
        addresses people who are not entering this pathway.
  
        Two-three weeks after the CT scan, the clinical team will invite people to attend for a
        research study to assess lung health if they have symptoms of cough, breathlessness or 2 or
        more courses antibiotics in the last 15 months. No further reminder will be sent. The
        investigators will not excluding people with COPD already and will not turn away high-risk
        people who self-present even if not had a CT.
  
        The invite will include mention of when the mobile unit is open and in their locality, what
        the visit consists of and that participants are free to come down at a convenient time. A
        telephone number and e-mail will be provided if somebody contacts the investigators and would
        prefer to be seen in a standard research unit - an appointment will be provided. The letter
        will remind participants that this cannot cover broader medical issues or emergencies, where
        usual clinical advice should be sought.
  
        Following informed consent, the following will occur by trained clinical research
        practitioners and under the support of a research nurse.
  
          -  Questionnaires:
  
               -  Symptom scores and information on tobacco smoking / other exposures, past medical
                  history, medication
  
               -  COPD Assessment Test (CAT) Quality of Life score
  
               -  Medical Research Council (MRC) breathlessness score
  
               -  Exacerbation frequency
  
               -  EQ5D - Health Status
  
          -  Observations:
  
               -  Oximetry for heart rate and oxygen saturations
  
               -  Height
  
               -  Weight
  
               -  Blood pressure
  
          -  Postbronchodilator spirometry - salbutamol delivered by trained staff.
  
          -  Forced Oscillation Technique (FOT)- a non-clinically used breathing test but might have
             a role in early detection.
  
          -  Approach for future research and store research data obtained here / review medical
             records for future medicines.
  
          -  Invite to provide a blood sample and nasal swab for early markers of COPD - optional and
             currently of no clinical relevance.
  
        Those with clinical evidence of COPD will be given information by a registered Health Care
        professional trained to do so on:
  
          -  COPD and what it is.
  
          -  Need for immunisations.
  
          -  General health education, self-management and tobacco cessation where indicated.
  
          -  Whether further review at the surgery is required.
  
          -  Clinical information will be fed back to primary care surgery and uploaded onto medical
             health records, such as SystemOne. The participant will have consented to this.
  
        The investigators will seek feedback from participants and subsequently from the primary care
        clinicians.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Proportion of people who take up the invite to attend for a C-FIND visit.
  time frame: 1.5 years
  description: 0-100%
  measure: Proportion diagnosed with COPD
  time frame: 1.5 years
  description: 0-100%
  measure: CAT COPD Quality of Life Score
  time frame: 1 day
  description: Questionnaire. Wellbeing and daily life questions, scored 0-40 points, lower better
  measure: MRC breathlessness score
  time frame: 1 day
  description: Questionnaire, self reported breathlessness grade 1-5, lower better
  measure: Exacerbation Frequency
  time frame: 1 day
  description: 0-12/year
  measure: EQ-5D-5L - Health Status
  time frame: 1 day
  description: Questionnaire. Self reported health scale 0-100. Greater better
  measure: Oximetry for oxygen saturations
  time frame: 1 day
  description: 75-100% Oxygen saturation
  measure: Height
  time frame: 1 day
  description: Participant height in metres - range 1.2-2.0m
  measure: Weight
  time frame: 1 day
  description: participant weight in Kg - range 35-180Kg
  measure: BMI
  time frame: 1 day
  description: 12-60g/m2
  measure: Blood pressure diastolic
  time frame: 1 day
  description: 40-120mmHg
  measure: Post bronchodilator Spirometry
  time frame: 1 day
  description: Forced Expired Volume (FEV)% - range 10-140% predicted
  measure: FOT-R (Resistance)
  time frame: 1 day
  description: cmH2O.s/l
  measure: FOT-X (reactance)
  time frame: 1 day
  description: cmH2O.s/l
  measure: FOT-AX (area of reactance)
  time frame: 1 day
  description: cmH2O/L
  measure: FOT-Fres (resonant Frequency)
  time frame: 1 day
  description: Hz
  measure: Blood pressure -systolic
  time frame: 1 day
  description: 75-230mmHg
  whole blood and nasal brush
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Charlotte Bolton, MD, PhD
  role: Principal Investigator
  affiliation: Nottingham University Hospitals NHS Trust
  last name: Joanne Porte, MSc
  phone: 0115 8231723
  email: Joanne.Porte@nottingham.ac.uk
  last name: Charlotte Bolton, MD
  email: Charlotte.Bolton@nottingham.ac.uk
  responsible party type: Sponsor
  mesh term: Pulmonary Disease, Chronic Obstructive