<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/NCT03272932</url>
  </required_header>
  <id_info>
    <org_study_id>CCUHK_Resp_ACOS_v1(5Apr2017)</org_study_id>
    <nct_id>NCT03272932</nct_id>
  </id_info>
  <brief_title>Clinical Characteristics of Asthma and COPD Overlap for Patients With Asthma and COPD in Hong Kong</brief_title>
  <official_title>A Cross-sectional Study to Assess the Proportion and Clinical Characteristics of Asthma and COPD Overlap for Patients With Asthma and COPD in Hong Kong.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      This study is to assess the prevalence of Asthma COPD Overlap in subjects with diagnosed&#xD;
      asthma and chronic obstructive pulmonary disease (COPD). The subsequent morbidity and&#xD;
      mortality of subjects will be followed up for 3 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale:&#xD;
&#xD;
      Around 15 to 20% of COPD patients have features of asthma. These patients have more frequent&#xD;
      and more severe exacerbations, and higher medical utilization. The Global Initiative for&#xD;
      Asthma (GINA) and Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines&#xD;
      have given joint recommendations on the identification, diagnosis and treatment of these&#xD;
      patients having Asthma-COPD Overlap (ACO). These are at present expert opinions and further&#xD;
      studies are needed to establish the optimal definitions and treatment options. The&#xD;
      recommendations proposed by the guidelines have been adapted for use in the Asia area&#xD;
      countries. Nonetheless, the application to clinical practice has not been well established&#xD;
      and there are no prevalence data available on the COPD with asthma symptom population or&#xD;
      asthma with COPD symptoms population based on the recommended features for identification.&#xD;
      This is the current data gap in Asia.&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
      To determine the proportion and clinical characteristics of patients with ACO as defined by&#xD;
      the joint GINA and GOLD recommendation amongst diagnosed COPD and asthma patients seen at the&#xD;
      out-patient clinics&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of prevalence of Asthma COPD overlap among the asthma and COPD subjects.</measure>
    <time_frame>3 years</time_frame>
    <description>To determine the proportion and clinical characteristics of patients with ACO as defined by the joint GINA and GOLD recommendation amongst diagnosed COPD and asthma patients seen at the out-patient clinics. (Assessment: % of subjects with ACO among patients with asthma and COPD respectively)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patient with treatment that is different from the guidelines recommendation</measure>
    <time_frame>3 years</time_frame>
    <description>To evaluate the gap between guideline recommendations and real-world clinical practice in identifying COPD patients with asthma and asthma patients with COPD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentages of patients on various medications (e.g. inhaled steroid, LABA, LAMA)</measure>
    <time_frame>3 years</time_frame>
    <description>To review the medications given to COPD patients with asthma and asthma patients with COPD compared to guideline recommendations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The pecentages of patients receiving different symptoms control assessments (e.g. use of Asthma control test, use of COPD assessment test)</measure>
    <time_frame>3 years</time_frame>
    <description>To review the current practices of symptom control assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of subjects with morbidity (e.g. congestive heart failure)</measure>
    <time_frame>3 years</time_frame>
    <description>To assess the 3 year morbidity of ACO patient compared to COPD and asthma patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of subjects with mortality</measure>
    <time_frame>3 years</time_frame>
    <description>To assess the 3 year mortality of ACO patient compared to COPD and asthma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of patients with various Genetic markers</measure>
    <time_frame>3 years</time_frame>
    <description>Genetic markers got differentiating ACO patients from patients with COPD or asthma</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1600</enrollment>
  <condition>COPD</condition>
  <condition>Asthma</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood will be stored for future genetic studies. As there is currently no good biomarker or&#xD;
      genetic tests that can identify the cause or suggest the diagnosis of Asthma COPD overlap,&#xD;
      this study would like to explore into this.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with asthma or COPD&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects must fulfil all of the following criteria:&#xD;
&#xD;
          -  All patients with confirmed diagnosis of COPD (post-bronchodilator FEV1/FVC&lt;0.7 based&#xD;
             on the medical records) 1 or asthma (defined as those with a consistent history and&#xD;
             prior documented evidence of variable airflow obstruction, with evidence of an&#xD;
             increase in FEV1 greater than 12% or 400 mL following bronchodilator or bronchial&#xD;
             hyperresponsiveness on bronchial provocation testing, when stable) 6&#xD;
&#xD;
          -  Aged &gt;40 years old&#xD;
&#xD;
          -  Signed written informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients currently with acute exacerbation of COPD by GOLD definition (any worsening&#xD;
             of a patient's respiratory symptoms that is beyond normal day-to-day variations and&#xD;
             requires a change in medication) 1 or acute exacerbation of asthma by GINA guideline.&#xD;
             6&#xD;
&#xD;
          -  Patients with respiratory diseases that can show similar symptoms to chronic airway&#xD;
             diseases such as bronchiectasis, tuberculosis (TB)-destroyed lung parenchyma,&#xD;
             endobronchial TB, and lung cancer, or those who have history of these diseases based&#xD;
             on physician's judgment&#xD;
&#xD;
          -  Patients currently diagnosed with pneumonia and acute bronchitis&#xD;
&#xD;
          -  Patients currently randomized in other clinical studies&#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>Fanny Ko, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>April Ip, BSc</last_name>
    <phone>852 35053396</phone>
    <email>april_ip@cuhk.edu.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fanny Ko, MD</last_name>
    <phone>852 35053133</phone>
    <email>fannyko@cuhk.edu.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fanny Ko, MD</last_name>
      <phone>852 35053133</phone>
      <email>fannyko@cuhk.edu.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Fanny W.S. Ko</investigator_full_name>
    <investigator_title>Honorary Clinical Associate Professor</investigator_title>
  </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/NCT03272932
org study id: CCUHK_Resp_ACOS_v1(5Apr2017)
nct id: NCT03272932
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to assess the prevalence of Asthma COPD Overlap in subjects with diagnosed
      asthma and chronic obstructive pulmonary disease (COPD). The subsequent morbidity and
      mortality of subjects will be followed up for 3 years.
Rationale:

      Around 15 to 20% of COPD patients have features of asthma. These patients have more frequent
      and more severe exacerbations, and higher medical utilization. The Global Initiative for
      Asthma (GINA) and Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
      have given joint recommendations on the identification, diagnosis and treatment of these
      patients having Asthma-COPD Overlap (ACO). These are at present expert opinions and further
      studies are needed to establish the optimal definitions and treatment options. The
      recommendations proposed by the guidelines have been adapted for use in the Asia area
      countries. Nonetheless, the application to clinical practice has not been well established
      and there are no prevalence data available on the COPD with asthma symptom population or
      asthma with COPD symptoms population based on the recommended features for identification.
      This is the current data gap in Asia.

      Primary objective:

      To determine the proportion and clinical characteristics of patients with ACO as defined by
      the joint GINA and GOLD recommendation amongst diagnosed COPD and asthma patients seen at the
      out-patient clinics
observational model: Case-Only
time perspective: Prospective
measure: Percentage of prevalence of Asthma COPD overlap among the asthma and COPD subjects.
time frame: 3 years
description: To determine the proportion and clinical characteristics of patients with ACO as defined by the joint GINA and GOLD recommendation amongst diagnosed COPD and asthma patients seen at the out-patient clinics. (Assessment: % of subjects with ACO among patients with asthma and COPD respectively)
measure: Percentage of patient with treatment that is different from the guidelines recommendation
time frame: 3 years
description: To evaluate the gap between guideline recommendations and real-world clinical practice in identifying COPD patients with asthma and asthma patients with COPD
measure: The percentages of patients on various medications (e.g. inhaled steroid, LABA, LAMA)
time frame: 3 years
description: To review the medications given to COPD patients with asthma and asthma patients with COPD compared to guideline recommendations
measure: The pecentages of patients receiving different symptoms control assessments (e.g. use of Asthma control test, use of COPD assessment test)
time frame: 3 years
description: To review the current practices of symptom control assessment
measure: Percentages of subjects with morbidity (e.g. congestive heart failure)
time frame: 3 years
description: To assess the 3 year morbidity of ACO patient compared to COPD and asthma patients.
measure: Percentages of subjects with mortality
time frame: 3 years
description: To assess the 3 year mortality of ACO patient compared to COPD and asthma
measure: Percentages of patients with various Genetic markers
time frame: 3 years
description: Genetic markers got differentiating ACO patients from patients with COPD or asthma
intervention type: Other
intervention name: No intervention
description: No intervention
Blood will be stored for future genetic studies. As there is currently no good biomarker or
      genetic tests that can identify the cause or suggest the diagnosis of Asthma COPD overlap,
      this study would like to explore into this.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fanny Ko, MD
role: Principal Investigator
affiliation: Chinese University of Hong Kong
last name: April Ip, BSc
phone: 852 35053396
email: april_ip@cuhk.edu.hk
last name: Fanny Ko, MD
phone: 852 35053133
email: fannyko@cuhk.edu.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Fanny W.S. Ko
investigator title: Honorary Clinical Associate Professor
mesh term: Asthma
sharing ipd: No