<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/NCT03817333</url>
  </required_header>
  <id_info>
    <org_study_id>CÉR21047</org_study_id>
    <nct_id>NCT03817333</nct_id>
  </id_info>
  <brief_title>The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome</brief_title>
  <official_title>The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome: A Comparison of Asthma Outcomes in Smoking vs Non-smoking Patients With an Incomplete Reversibility of Airway Obstruction (IRAO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laval University</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>
      RATIONALE:&#xD;
&#xD;
      In asthmatic subjects, smoking can lead to several changes in disease characterictics. in&#xD;
      smokers of more than 20 pack-years, chronic obstructive pulmonary disease (COPD) can be&#xD;
      associated with asthma, also called asthma-COPD overlap syndrome (ACOS). Increasing data&#xD;
      support the concept that ACOS is a clinical entity. However, this should be further studied&#xD;
      in order to better target therapy.&#xD;
&#xD;
      AIM:&#xD;
&#xD;
      The objective of this study is to evaluate the comparative features of ACOS&#xD;
&#xD;
      METHODS:&#xD;
&#xD;
      This will be a descriptive study comparing the features of the ACOS with the features of&#xD;
      asthmatic subjects with an incomplete reversibility of airway obstruction (IRAO).The study&#xD;
      will be done over 1 or 2 visits (within a week interval), according to subjects'&#xD;
      availability. The visit will include completion of different questionnaires (asthma control&#xD;
      asthma quality of life, medical history, exacerbations, etc.), a thoracic examination,&#xD;
      allergy skin-prick tests, spirometry and bronchodilator response, lung volumes and compliance&#xD;
      measurements, exhaled nitric oxide measurement, blood sampling and a sputum induction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total asthma control questionnaire (ACQ) score</measure>
    <time_frame>Baseline</time_frame>
    <description>Measurement of asthma control using a 0-6 scale. The questionnaire includes 6 questions. Total score is the mean of the scores from all questions. Total score ranges from 0 to 6. A lower score is better.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spirometry results</measure>
    <time_frame>Baseline</time_frame>
    <description>Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sputum eosinophil percentage</measure>
    <time_frame>Baseline</time_frame>
    <description>Percentage of sputum eosinophils</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Blood biomarkers</measure>
    <time_frame>Baseline</time_frame>
    <description>alpha 1 antitrypsine, C-reactive protein (CRP), fibrinogen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma quality of life questionnaire (AQLQ) score</measure>
    <time_frame>Baseline</time_frame>
    <description>Measurement of asthma quality of life using the Mini asthma quality of life questionnaire. It is a 7-point scale questionnaire (where 1 is greatest impairment and 7 is least impairment) containing 15 uqestions divided into 4 domains : symptoms (5 items), activity limitation (4 items), emotional function (3 items), and exposure to environmental stimuli (3 items). during the last 2 weeks. The overall score is the mean of all the responses. Each domain score is calculated from the mean of the items that relate to it.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with comorbidities</measure>
    <time_frame>Baseline</time_frame>
    <description>gastro-oesophageal reflux disease (GERD), obstructive sleep apnea (OSA), anxiety, depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of asthma exacerbations in the previous year</measure>
    <time_frame>Baseline</time_frame>
    <description>emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline total Asthma Control Questionnaire (ACQ) score at one-year follow-up</measure>
    <time_frame>Baseline to one-year follow-up</time_frame>
    <description>Measurement of asthma control using a 0-6 scale. The questionnaire includes 6 questions. Total score is the mean of the scores from all questions. Total score ranges from 0 to 6. A lower score is better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline number of exacerbations at one-year follow-up</measure>
    <time_frame>Baseline to one-year follow-up</time_frame>
    <description>emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">115</enrollment>
  <condition>Asthma</condition>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>ACOS smoking history &gt;20 pack-years</arm_group_label>
    <description>Subjects with asthma-COPD overlap syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IRAO smoking history &lt;5 pack-years</arm_group_label>
    <description>Subjects with an incomplete reversibility of airway obstruction</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Sputum and blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Asthmatic subjects will be recruited from the asthma outpatient clinic, from participation&#xD;
        to past research studies, or from advertisements.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ALL SUBJECTS&#xD;
&#xD;
          1. Subjects aged 45 years and older.&#xD;
&#xD;
          2. Free of any other respiratory condition, except for asthma and/or COPD, which may&#xD;
             interfere with the tests.&#xD;
&#xD;
          3. Asthma that requires a baseline treatment with inhaled corticosteroids and/or&#xD;
             additional asthma medication.&#xD;
&#xD;
          4. Free of respiratory infection in the 4 weeks preceding the study.&#xD;
&#xD;
          5. No changes in the asthma and COPD-related medications in the 4 weeks preceding the&#xD;
             study.&#xD;
&#xD;
          6. If female, not pregnant (or lactating).&#xD;
&#xD;
          7. Able to adhere to study procedures.&#xD;
&#xD;
          8. Able and willing to provide written informed consent to participate in the study, in&#xD;
             accordance with international conference on harmonization (ICH) good clinical practice&#xD;
             (GCP) requirements.&#xD;
&#xD;
        ACOS SUBJECTS&#xD;
&#xD;
        1. Smokers or ex-smokers of at least 20 pack-years. 2. With an IRAO (see definitions&#xD;
        section). IRAO SUBJECTS&#xD;
&#xD;
          1. Long-life non-smokers or ex-smokers defined as someone who smoked less than 5&#xD;
             pack-years and who completely stopped smoking for at least 12 months before inclusion&#xD;
             in the study.&#xD;
&#xD;
          2. With an IRAO.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ALL SUBJECTS&#xD;
&#xD;
               1. With COPD without a past diagnosis of asthma.&#xD;
&#xD;
               2. Unstable respiratory or non-respiratory condition.&#xD;
&#xD;
               3. Any active chronic inflammatory disease.&#xD;
&#xD;
               4. Any evidence of malignancy (active and/or treated) within the previous 5 years.&#xD;
&#xD;
               5. Any significant concomitant illness or injury that would interfere with the&#xD;
                  subject's participation in the study.&#xD;
&#xD;
               6. Any history of bronchial thermoplasty. IRAO SUBJECTS&#xD;
&#xD;
               1. Use of any nicotine containing product within 1 year prior to study entry or a&#xD;
                  smoking history of &gt; 5 pack-years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Louis-Philippe Boulet, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Laval University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut universitaire de cardiologie et de pneumologie de Québec</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 13, 2016</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>phenotype</keyword>
  <keyword>inflammation</keyword>
  <keyword>pulmonary function</keyword>
  <keyword>comorbidities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>October 29, 2020</submitted>
    <returned>November 20, 2020</returned>
  </pending_results>
  <!-- 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/NCT03817333
org study id: CÉR21047
nct id: NCT03817333
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
RATIONALE:

      In asthmatic subjects, smoking can lead to several changes in disease characterictics. in
      smokers of more than 20 pack-years, chronic obstructive pulmonary disease (COPD) can be
      associated with asthma, also called asthma-COPD overlap syndrome (ACOS). Increasing data
      support the concept that ACOS is a clinical entity. However, this should be further studied
      in order to better target therapy.

      AIM:

      The objective of this study is to evaluate the comparative features of ACOS

      METHODS:

      This will be a descriptive study comparing the features of the ACOS with the features of
      asthmatic subjects with an incomplete reversibility of airway obstruction (IRAO).The study
      will be done over 1 or 2 visits (within a week interval), according to subjects'
      availability. The visit will include completion of different questionnaires (asthma control
      asthma quality of life, medical history, exacerbations, etc.), a thoracic examination,
      allergy skin-prick tests, spirometry and bronchodilator response, lung volumes and compliance
      measurements, exhaled nitric oxide measurement, blood sampling and a sputum induction.
observational model: Case-Control
time perspective: Prospective
measure: Total asthma control questionnaire (ACQ) score
time frame: Baseline
description: Measurement of asthma control using a 0-6 scale. The questionnaire includes 6 questions. Total score is the mean of the scores from all questions. Total score ranges from 0 to 6. A lower score is better.
measure: Spirometry results
time frame: Baseline
description: Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC
measure: Sputum eosinophil percentage
time frame: Baseline
description: Percentage of sputum eosinophils
measure: Concentration of Blood biomarkers
time frame: Baseline
description: alpha 1 antitrypsine, C-reactive protein (CRP), fibrinogen
measure: Asthma quality of life questionnaire (AQLQ) score
time frame: Baseline
description: Measurement of asthma quality of life using the Mini asthma quality of life questionnaire. It is a 7-point scale questionnaire (where 1 is greatest impairment and 7 is least impairment) containing 15 uqestions divided into 4 domains : symptoms (5 items), activity limitation (4 items), emotional function (3 items), and exposure to environmental stimuli (3 items). during the last 2 weeks. The overall score is the mean of all the responses. Each domain score is calculated from the mean of the items that relate to it.
measure: Number of patients with comorbidities
time frame: Baseline
description: gastro-oesophageal reflux disease (GERD), obstructive sleep apnea (OSA), anxiety, depression
measure: Number of asthma exacerbations in the previous year
time frame: Baseline
description: emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits
measure: Change from baseline total Asthma Control Questionnaire (ACQ) score at one-year follow-up
time frame: Baseline to one-year follow-up
description: Measurement of asthma control using a 0-6 scale. The questionnaire includes 6 questions. Total score is the mean of the scores from all questions. Total score ranges from 0 to 6. A lower score is better.
measure: Change from baseline number of exacerbations at one-year follow-up
time frame: Baseline to one-year follow-up
description: emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits
arm group label: ACOS smoking history >20 pack-years
description: Subjects with asthma-COPD overlap syndrome
arm group label: IRAO smoking history <5 pack-years
description: Subjects with an incomplete reversibility of airway obstruction
Sputum and blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Louis-Philippe Boulet, MD
role: Principal Investigator
affiliation: Laval University
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Asthma
submitted: October 29, 2020
returned: November 20, 2020