<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/NCT02985814</url>
  </required_header>
  <id_info>
    <org_study_id>0066-14-COM</org_study_id>
    <nct_id>NCT02985814</nct_id>
  </id_info>
  <brief_title>Identifying Patients With the COPD-Asthma Overlap Phenotype: Therapeutic Implications</brief_title>
  <official_title>Identifying Patients With the COPD-Asthma Overlap Phenotype: Therapeutic Implications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clalit Health Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clalit Health Services</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Asthma and COPD are considered different diseases but many patients share&#xD;
      characteristics of both entities. This has been termed &quot;COPD-asthma overlap syndrome&quot;.&#xD;
&#xD;
      Study objective: To examine: (a) the frequency of the overlap phenotype among patients&#xD;
      referred for pulmonary function testing and, (b) the impact of this phenotype on the&#xD;
      therapeutic management and the quality of life of these patients as compared with patients&#xD;
      with COPD only and asthma only.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Type of study: Observational, cross-sectional. Study subjects: Patients referred for&#xD;
      pulmonary function test diagnosed with airway obstruction (FEV1/FVC &lt; 0.7) willing to sign an&#xD;
      informed consent.&#xD;
&#xD;
      Study procedures: Spirometry will be performed before and after the administration of a&#xD;
      bronchodilator. Respiratory questionnaire: Questionnaires about smoking habits, past history&#xD;
      of asthma and wheezing, current medications and history of exacerbations will be administered&#xD;
      at inclusion. Questionnaire on medication utilization will be administered by telephone one&#xD;
      month after inclusion. Quality of life: Will be assessed using the Saint George Respiratory&#xD;
      Questionnaire (SGRQ).&#xD;
&#xD;
      Working definitions: The following definitions will be adopted: a) COPD only: smoking history&#xD;
      &gt; 10 pack/years and post-bronchodilator (BD) FEV1/FVC ratio of &lt; 0.70; b) Asthma only: (1)&#xD;
      presence of wheezing in the last year plus a minimum post-BD increase in FEV1 or FVC of 12%&#xD;
      and 200 ml; (2) prior physician diagnosis (before age 40); and c) both COPD-Asthma (the&#xD;
      overlap group) - the combination of the two.&#xD;
&#xD;
      Outcome measures: The clinical outcome is the prevalence rate of the phenotypes.&#xD;
      Patient-reported outcomes will include the utilization of medication, the number of&#xD;
      exacerbations, and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Asthma and COPD are considered different diseases but many patients share&#xD;
      characteristics of both entities. This has been termed &quot;COPD-asthma overlap syndrome&quot;.&#xD;
&#xD;
      Study objective: To examine: (a) the frequency of the overlap phenotype among patients&#xD;
      referred for pulmonary function testing and, (b) the impact of this phenotype on the&#xD;
      therapeutic management and the quality of life of these patients as compared with patients&#xD;
      with COPD only and asthma only.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Type of study: Observational, cross-sectional. Study subjects: Patients referred for&#xD;
      pulmonary function test diagnosed with airway obstruction (FEV1/FVC &lt; 0.7) willing to sign an&#xD;
      informed consent.&#xD;
&#xD;
      Study procedures: Spirometry will be performed before and after the administration of a&#xD;
      bronchodilator. Respiratory questionnaire: Questionnaires about smoking habits, past history&#xD;
      of asthma and wheezing, current medications and history of exacerbations will be administered&#xD;
      at inclusion. Questionnaire on medication utilization will be administered by telephone one&#xD;
      month after inclusion. Quality of life: Will be assessed using the Saint George Respiratory&#xD;
      Questionnaire (SGRQ).&#xD;
&#xD;
      Working definitions: The following definitions will be adopted: a) COPD only: smoking history&#xD;
      &gt; 10 pack/years and post-bronchodilator (BD) FEV1/FVC ratio of &lt; 0.70; b) Asthma only: (1)&#xD;
      presence of wheezing in the last year plus a minimum post-BD increase in FEV1 or FVC of 12%&#xD;
      and 200 ml; (2) prior physician diagnosis (before age 40); and c) both COPD-Asthma (the&#xD;
      overlap group) - the combination of the two.&#xD;
&#xD;
      Outcome measures: The clinical outcome is the prevalence rate of the phenotypes.&#xD;
      Patient-reported outcomes will include the utilization of medication, the number of&#xD;
      exacerbations, and quality of life.&#xD;
&#xD;
      Statistical plan: Sample size: For an estimated prevalence rate of 20%, 246 patients should&#xD;
      be recruited with 5% imprecision and 95% degree of confidence. To round up, 250 patients will&#xD;
      be included. Statistical methods: Multiple comparisons will be carried out using the one-way&#xD;
      ANOVA for continuous variables and chi-squared test (or Fisher Exact Test) for qualitative&#xD;
      variables. Multiple logistic regression models will be tested to examine the relation between&#xD;
      the &quot;COPD-asthma overlap&quot; phenotype and various independent or predictor variables.&#xD;
&#xD;
      Expected benefits: Data collected could serve to advance the medical community's knowledge&#xD;
      pertaining to the COPD-asthma overlap syndrome. Most importantly, however, they will&#xD;
      encourage reflection on the best therapeutic options for the patients with the overlap&#xD;
      syndrome. Indeed, recommendations on this matter are noticeably absent from the current&#xD;
      guidelines proposed to treat and monitor obstructive lung diseases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2015</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Months</target_duration>
  <primary_outcome>
    <measure>utilization of medication</measure>
    <time_frame>enrollment to 2 months</time_frame>
    <description>completion of RS questionnaires</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of exacerbations</measure>
    <time_frame>enrollment to 2 months</time_frame>
    <description>completion of RS questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>enrollment</time_frame>
    <description>completion of Saint George Respiratory Questionnaire</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">271</enrollment>
  <condition>COPD Asthma</condition>
  <arm_group>
    <arm_group_label>patients with airway obstruction</arm_group_label>
    <description>Patients referred for pulmonary function test diagnosed with airway obstruction (FEV1/FVC &lt; 0.7) willing to sign an informed consent.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        men or women aged &gt; 18 years, with spirometric evidence of airway obstruction defined as an&#xD;
        FEV1/FVC ratio &lt; 0.7&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        men or women aged &gt; 18 years , with spirometric evidence of airway obstruction defined as&#xD;
        an FEV1/FVC ratio &lt; 0.7&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects with normal spirometry or presenting a pattern of restrictive lung disease will be&#xD;
        listed for the purpose of characterising the source population but will not enter the study&#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>Gabriel IZBICKI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clalit Health Services</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ROKACH institute</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>February 5, 2018</last_update_submitted>
  <last_update_submitted_qc>February 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD Asthma Overlap</keyword>
  <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/NCT02985814
org study id: 0066-14-COM
nct id: NCT02985814
lead sponsor: 
has dmc: No
Background: Asthma and COPD are considered different diseases but many patients share
      characteristics of both entities. This has been termed "COPD-asthma overlap syndrome".

      Study objective: To examine: (a) the frequency of the overlap phenotype among patients
      referred for pulmonary function testing and, (b) the impact of this phenotype on the
      therapeutic management and the quality of life of these patients as compared with patients
      with COPD only and asthma only.

      Methods:

      Type of study: Observational, cross-sectional. Study subjects: Patients referred for
      pulmonary function test diagnosed with airway obstruction (FEV1/FVC < 0.7) willing to sign an
      informed consent.

      Study procedures: Spirometry will be performed before and after the administration of a
      bronchodilator. Respiratory questionnaire: Questionnaires about smoking habits, past history
      of asthma and wheezing, current medications and history of exacerbations will be administered
      at inclusion. Questionnaire on medication utilization will be administered by telephone one
      month after inclusion. Quality of life: Will be assessed using the Saint George Respiratory
      Questionnaire (SGRQ).

      Working definitions: The following definitions will be adopted: a) COPD only: smoking history
      > 10 pack/years and post-bronchodilator (BD) FEV1/FVC ratio of < 0.70; b) Asthma only: (1)
      presence of wheezing in the last year plus a minimum post-BD increase in FEV1 or FVC of 12%
      and 200 ml; (2) prior physician diagnosis (before age 40); and c) both COPD-Asthma (the
      overlap group) - the combination of the two.

      Outcome measures: The clinical outcome is the prevalence rate of the phenotypes.
      Patient-reported outcomes will include the utilization of medication, the number of
      exacerbations, and quality of life.
Background: Asthma and COPD are considered different diseases but many patients share
      characteristics of both entities. This has been termed "COPD-asthma overlap syndrome".

      Study objective: To examine: (a) the frequency of the overlap phenotype among patients
      referred for pulmonary function testing and, (b) the impact of this phenotype on the
      therapeutic management and the quality of life of these patients as compared with patients
      with COPD only and asthma only.

      Methods:

      Type of study: Observational, cross-sectional. Study subjects: Patients referred for
      pulmonary function test diagnosed with airway obstruction (FEV1/FVC < 0.7) willing to sign an
      informed consent.

      Study procedures: Spirometry will be performed before and after the administration of a
      bronchodilator. Respiratory questionnaire: Questionnaires about smoking habits, past history
      of asthma and wheezing, current medications and history of exacerbations will be administered
      at inclusion. Questionnaire on medication utilization will be administered by telephone one
      month after inclusion. Quality of life: Will be assessed using the Saint George Respiratory
      Questionnaire (SGRQ).

      Working definitions: The following definitions will be adopted: a) COPD only: smoking history
      > 10 pack/years and post-bronchodilator (BD) FEV1/FVC ratio of < 0.70; b) Asthma only: (1)
      presence of wheezing in the last year plus a minimum post-BD increase in FEV1 or FVC of 12%
      and 200 ml; (2) prior physician diagnosis (before age 40); and c) both COPD-Asthma (the
      overlap group) - the combination of the two.

      Outcome measures: The clinical outcome is the prevalence rate of the phenotypes.
      Patient-reported outcomes will include the utilization of medication, the number of
      exacerbations, and quality of life.

      Statistical plan: Sample size: For an estimated prevalence rate of 20%, 246 patients should
      be recruited with 5% imprecision and 95% degree of confidence. To round up, 250 patients will
      be included. Statistical methods: Multiple comparisons will be carried out using the one-way
      ANOVA for continuous variables and chi-squared test (or Fisher Exact Test) for qualitative
      variables. Multiple logistic regression models will be tested to examine the relation between
      the "COPD-asthma overlap" phenotype and various independent or predictor variables.

      Expected benefits: Data collected could serve to advance the medical community's knowledge
      pertaining to the COPD-asthma overlap syndrome. Most importantly, however, they will
      encourage reflection on the best therapeutic options for the patients with the overlap
      syndrome. Indeed, recommendations on this matter are noticeably absent from the current
      guidelines proposed to treat and monitor obstructive lung diseases.
observational model: Other
time perspective: Prospective
measure: utilization of medication
time frame: enrollment to 2 months
description: completion of RS questionnaires
measure: number of exacerbations
time frame: enrollment to 2 months
description: completion of RS questionnaires
measure: quality of life
time frame: enrollment
description: completion of Saint George Respiratory Questionnaire
arm group label: patients with airway obstruction
description: Patients referred for pulmonary function test diagnosed with airway obstruction (FEV1/FVC < 0.7) willing to sign an informed consent.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gabriel IZBICKI, MD
role: Principal Investigator
affiliation: Clalit Health Services
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No