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/NCT06014840</url>
    </required_header>
    <id_info>
      <org_study_id>2023</org_study_id>
      <nct_id>NCT06014840</nct_id>
    </id_info>
    <brief_title>The UCAP 2 Pilot Study</brief_title>
    <official_title>Early Diagnosis and Treatment of Undiagnosed COPD or Asthma: The UCAP 2 Trial - Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ottawa Hospital Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Canadian Institutes of Health Research (CIHR)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ottawa Hospital Research Institute</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Our research group has found that Canadians with undiagnosed asthma or chronic obstructive&#xD;
        pulmonary disease (COPD) have increased respiratory symptoms and worse health-related quality&#xD;
        of life.&#xD;
  &#xD;
        The investigators recently developed and validated an on-line questionnaire to accurately&#xD;
        identify these symptomatic, undiagnosed individuals.&#xD;
  &#xD;
        The investigators will advertise in the community asking individuals to complete the on-line&#xD;
        questionnaire at home, at their leisure, to determine if they are at risk of asthma or COPD.&#xD;
        Those at risk will be invited to participate in our randomized, controlled clinical trial to&#xD;
        determine if guidelines-based treatment of newly discovered undiagnosed asthma or COPD will&#xD;
        improve their quality of life and clinical outcomes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2028</completion_date>
    <primary_completion_date type="Anticipated">December 2027</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>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ).</measure>
      <time_frame>12 weeks</time_frame>
      <description>The change in disease-specific quality of life will be expressed as the total St. George's Respiratory Questionnaire score at 12 weeks minus the score on the day of randomization. This questionnaire includes 3 domains: symptoms (distress caused by specific respiratory symptoms); activity (physical activities that cause or are limited by breathlessness); and impact (social and psychological effects of the respiratory disease). A total change of - 4 points in the SGRQ total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate poor health status.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in dyspnea as assessed by The Baseline and Transitional Dyspnea Indexes</measure>
      <time_frame>12 weeks</time_frame>
      <description>The baseline dyspnea index (BDI) is used to rate the severity of dyspnea at a single point in time and the transition dyspnea index (TDI) is used to assess changes from that baseline. The change in dyspnea will be expressed as the total score at 12 weeks minus the score on the day of randomization. A total change of more than 1 point in the score has been established as the minimal clinically important difference (MCID) for this questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT)</measure>
      <time_frame>12 weeks</time_frame>
      <description>The change in overall respiratory symptom burden will be expressed as the total score of the COPD Assessment Test at 12 weeks minus the score on the day of randomization. A total change of 2 points in the CAT total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate higher burden.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in absenteeism and presenteeism as assessed by the Work Productivity and Activity Impairment Questionnaire (WPAI)</measure>
      <time_frame>12 weeks</time_frame>
      <description>The change in absenteeism and presenteeism will be assessed over the 12 week study period. Higher scores indicate greater impairment in work productivity and daily activities.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire</measure>
      <time_frame>12 weeks</time_frame>
      <description>The change in general health status will be expressed as the total score of the SF-36 Health Survey Questionnaire at 12 weeks minus the score on the day of randomization. A total change of 8-10 points in the SF-36 has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate better health status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing.</measure>
      <time_frame>12 weeks</time_frame>
      <description>The change will be expressed as the mean change in the FEV1 measurements at 12 weeks in comparison to the lung function measurements on the day of randomization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Differences between groups in patient-initiated healthcare utilization events for respiratory illness over the 12-week trial period.</measure>
      <time_frame>12 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>COPD</condition>
    <condition>Asthma</condition>
    <arm_group>
      <arm_group_label>Early diagnosis and treatment of COPD or Asthma</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Treatment strategy using evidence-based guidelines for asthma or COPD provided to participant on the day of randomization</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Delayed diagnosis and treatment of COPD or Asthma</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Treatment strategy using evidence-based guidelines for asthma or COPD provided to participant at 12 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD</intervention_name>
      <description>Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD</description>
      <arm_group_label>Delayed diagnosis and treatment of COPD or Asthma</arm_group_label>
      <arm_group_label>Early diagnosis and treatment of COPD or Asthma</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals at least 18 years old&#xD;
  &#xD;
            -  Individuals must be symptomatic with respiratory symptoms&#xD;
  &#xD;
            -  Individuals must complete the UCAP-Q questionnaire and score a ≥ 6% probability of&#xD;
               having either asthma or COPD.&#xD;
  &#xD;
            -  Individuals who have given written informed consent to participate in this trial in&#xD;
               accordance with local regulations;&#xD;
  &#xD;
            -  Individual must be able to perform pre and post bronchodilator spirometry to measure&#xD;
               lung function&#xD;
  &#xD;
          Additional Inclusion Criteria for the Randomized Controlled Trial (RCT):&#xD;
  &#xD;
            -  Individuals who have undiagnosed airflow obstruction (i.e. Asthma will be diagnosed in&#xD;
               subjects with airflow obstruction whose forced expiratory volume in 1 second (FEV1)&#xD;
               improves by &gt; 12% and 200 ml after bronchodilator and COPD will be diagnosed in&#xD;
               subjects who do not have a significant bronchodilator response and who exhibit&#xD;
               persistent airflow obstruction post bronchodilator) will be asked to participate in&#xD;
               the RCT.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals who report a previous diagnosis of asthma, COPD, history of lung cancer,&#xD;
               bronchiectasis, interstitial lung disease, cystic fibrosis or other significant&#xD;
               diagnosed lung disease.&#xD;
  &#xD;
            -  Individuals currently under the care of a respirologist&#xD;
  &#xD;
            -  Individuals currently using inhaled corticosteroids or long-acting bronchodilators.&#xD;
  &#xD;
            -  Individuals with history of myocardial infarction, stroke, aortic or cerebral&#xD;
               aneurysm, or detached retina or eye surgery within the past 3 months (spirometry is&#xD;
               contraindicated)&#xD;
  &#xD;
            -  Individuals who are in the third trimester of pregnancy&#xD;
  &#xD;
            -  Individuals involved in another interventional trial&#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>Kathy Vandemheen</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ottawa Hospital Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shawn Aaron</last_name>
      <phone>613-737-8899</phone>
      <phone_ext>74729</phone_ext>
      <email>saaron@ohri.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kathy Vandemheen</last_name>
      <phone>613-737-8259</phone>
      <email>kvandemheen@toh.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ottawa Hospital General Campus</name>
        <address>
          <city>Ottawa</city>
          <state>Ontario</state>
          <zip>K1H 8L6</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Kathy Vandemheen, RN, MScN</last_name>
        <phone>613-737-8259</phone>
        <email>kvandemheen@toh.ca</email>
      </contact>
      <contact_backup>
        <last_name>Susan Deveau, RRT</last_name>
        <phone>613-737-8899</phone>
        <phone_ext>74765</phone_ext>
        <email>sdeveau@ohri.ca</email>
      </contact_backup>
      <investigator>
        <last_name>Shawn Aaron, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sunita Mulpuru, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 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>Asthma</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/NCT06014840
  org study id: 2023
  nct id: NCT06014840
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Our research group has found that Canadians with undiagnosed asthma or chronic obstructive
        pulmonary disease (COPD) have increased respiratory symptoms and worse health-related quality
        of life.
  
        The investigators recently developed and validated an on-line questionnaire to accurately
        identify these symptomatic, undiagnosed individuals.
  
        The investigators will advertise in the community asking individuals to complete the on-line
        questionnaire at home, at their leisure, to determine if they are at risk of asthma or COPD.
        Those at risk will be invited to participate in our randomized, controlled clinical trial to
        determine if guidelines-based treatment of newly discovered undiagnosed asthma or COPD will
        improve their quality of life and clinical outcomes.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Single (Outcomes Assessor)
  measure: Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ).
  time frame: 12 weeks
  description: The change in disease-specific quality of life will be expressed as the total St. George's Respiratory Questionnaire score at 12 weeks minus the score on the day of randomization. This questionnaire includes 3 domains: symptoms (distress caused by specific respiratory symptoms); activity (physical activities that cause or are limited by breathlessness); and impact (social and psychological effects of the respiratory disease). A total change of - 4 points in the SGRQ total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate poor health status.
  measure: Change in dyspnea as assessed by The Baseline and Transitional Dyspnea Indexes
  time frame: 12 weeks
  description: The baseline dyspnea index (BDI) is used to rate the severity of dyspnea at a single point in time and the transition dyspnea index (TDI) is used to assess changes from that baseline. The change in dyspnea will be expressed as the total score at 12 weeks minus the score on the day of randomization. A total change of more than 1 point in the score has been established as the minimal clinically important difference (MCID) for this questionnaire.
  measure: Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT)
  time frame: 12 weeks
  description: The change in overall respiratory symptom burden will be expressed as the total score of the COPD Assessment Test at 12 weeks minus the score on the day of randomization. A total change of 2 points in the CAT total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate higher burden.
  measure: Changes in absenteeism and presenteeism as assessed by the Work Productivity and Activity Impairment Questionnaire (WPAI)
  time frame: 12 weeks
  description: The change in absenteeism and presenteeism will be assessed over the 12 week study period. Higher scores indicate greater impairment in work productivity and daily activities.
  measure: Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire
  time frame: 12 weeks
  description: The change in general health status will be expressed as the total score of the SF-36 Health Survey Questionnaire at 12 weeks minus the score on the day of randomization. A total change of 8-10 points in the SF-36 has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate better health status.
  measure: Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing.
  time frame: 12 weeks
  description: The change will be expressed as the mean change in the FEV1 measurements at 12 weeks in comparison to the lung function measurements on the day of randomization.
  measure: Differences between groups in patient-initiated healthcare utilization events for respiratory illness over the 12-week trial period.
  time frame: 12 weeks
  arm group label: Early diagnosis and treatment of COPD or Asthma
  arm group type: Active Comparator
  description: Treatment strategy using evidence-based guidelines for asthma or COPD provided to participant on the day of randomization
  arm group label: Delayed diagnosis and treatment of COPD or Asthma
  arm group type: Other
  description: Treatment strategy using evidence-based guidelines for asthma or COPD provided to participant at 12 weeks.
  intervention type: Other
  intervention name: Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD
  description: Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD
  arm group label: Delayed diagnosis and treatment of COPD or Asthma
  arm group label: Early diagnosis and treatment of COPD or Asthma
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kathy Vandemheen
  role: Principal Investigator
  affiliation: Ottawa Hospital Research Institute
  last name: Shawn Aaron
  phone: 613-737-8899
  phone ext: 74729
  email: saaron@ohri.ca
  last name: Kathy Vandemheen
  phone: 613-737-8259
  email: kvandemheen@toh.ca
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Asthma