<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/NCT04463589</url>
  </required_header>
  <id_info>
    <org_study_id>2019_36</org_study_id>
    <secondary_id>2020-A00085-34</secondary_id>
    <nct_id>NCT04463589</nct_id>
  </id_info>
  <brief_title>Presenteeism in Severe Asthma Treated by Biotherapyasthma</brief_title>
  <acronym>PRESATHMA</acronym>
  <official_title>Factors Associated With the Evolution of Presenteeism Under Biotherapy in Severe Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      Severe asthma is a condition characterized by a lower sensitivity to high doses of inhaled&#xD;
      corticosteroids combined with a second controller, most often a long-acting bronchodilator.&#xD;
      It concerns approximately 5% of asthmatics. Treatment failure and co-morbidities induced by&#xD;
      systemic corticosteroid therapy can cause debilitating dyspnea, limited physical activity,&#xD;
      and impaired quality of life. Severe asthma could therefore be associated with major&#xD;
      presenteeism, defined as the presence of an employee at work despite his health issues and&#xD;
      which implies a limitation of the employee's productive capacity. Uncontrolled asthma and&#xD;
      co-morbidities of asthma have been shown to be associated with a decrease in work&#xD;
      productivity that includes absenteeism and presenteeism. Although there is little data, a&#xD;
      recent study found a decline in work productivity in severe asthma. Various factors&#xD;
      associated with presenteeism could be involved, such as asthma control, frequency and&#xD;
      severity of exacerbations, comorbidities, or treatments.&#xD;
&#xD;
      Biotherapies targeting the signaling pathways involved in airway inflammation improve asthma&#xD;
      control, decrease the frequency of asthma exacerbations which are major determinants of&#xD;
      quality of life, improve lung function, and allow oral steroid sparing. Biotherapies could&#xD;
      therefore be associated with a decrease in presenteeism.&#xD;
&#xD;
      The objective of the study is to describe the evolution of presenteeism at work, evaluated by&#xD;
      the WPAI: Asthma, after 6 months of treatment by biotherapy and to identify factors&#xD;
      associated with this evolution&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">January 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>Change in presenteeism</measure>
    <time_frame>At 6 months</time_frame>
    <description>Change Questionnaire Work Productivity and activity impairment : Asthma (WPAI : Asthma) - question 5 (Q5) after 6 months of biotherapy The WPAI-question 5 ranges from 0 to 10, a higher score meaning a worse outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between the WPAI : Asthma- Q5 score and the ACQ-6 score</measure>
    <time_frame>at baseline</time_frame>
    <description>Association between presenteeism and asthma control Asthma Control Questionnaire (ACQ) is simple questionnaire to measure the adequacy of asthma control and change in asthma control, 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the WPAI : Asthma- Q5 score and the mMRC score</measure>
    <time_frame>at baseline</time_frame>
    <description>Association between presenteeism and exercise dyspnea at baseline the mMRC (Modified Medical Research Council) Dyspnea Scale,The 1-5 stage scale is used alongside the questionnaire to establish clinical grades of breathlessness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the WPAI : Asthma- Q5 score and FEV1, la FVC and RV.</measure>
    <time_frame>at baseline</time_frame>
    <description>Association between presenteeism and airways obstruction at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the WPAI : Asthma- Q5 score and the STAI-Y2 score</measure>
    <time_frame>at baseline</time_frame>
    <description>Association between presenteeism and anxiety at baseline tate-Trait Anxiety Inventory, STAI-Y2 (STAI-Y2), consists of 20 sentences assessing the subject's usual emotional state.Each answer to an item in the STAI-Y is scored from 1 to 4, with 1 indicating the lowest degree of anxiety and 4 the highest degree of anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the WPAI : Asthma- Q5 score and the Nijmegen score</measure>
    <time_frame>at baseline</time_frame>
    <description>Association between presenteeism and hyperventilation symptoms at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the WPAI : Asthma- Q5 score and the SNOT-22 score</measure>
    <time_frame>at baseline</time_frame>
    <description>Association between presenteeism and sino-nasal symptoms at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the WPAI : Asthma- Q5 score and the AQLQ score</measure>
    <time_frame>at baseline</time_frame>
    <description>Association between presenteeism and quality of life at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the WPAI : Asthma- Q5 score and the daily dose of oral corticosteroids</measure>
    <time_frame>at baseline</time_frame>
    <description>Association between presenteeism and daily dose of oral corticosteroids at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the WPAI : Asthma- Q5 score and the cumulative dose over 6 months of oral corticosteroids</measure>
    <time_frame>at baseline</time_frame>
    <description>Association between presenteeism and cumulative dose over 6 months of oral corticosteroids at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the change in the WPAI : Asthma- Q5 score and in the ACQ-6 score</measure>
    <time_frame>at baseline and at 6 months</time_frame>
    <description>Association between the change in presenteeism and in asthma control after 6 months of biotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the change in the WPAI : Asthma- Q5 score and in the mMRC score</measure>
    <time_frame>at baseline and at 6 months</time_frame>
    <description>Association between the change in presenteeism and in exercise dyspnea after 6 months of biotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the change in the WPAI : Asthma- Q5 score and in FEV1 and R5-R20</measure>
    <time_frame>at baseline and at 6 months</time_frame>
    <description>Association between the change in presenteeism and in airways obstruction after 6 months of biotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the change in the WPAI : Asthma- Q5 score and in the STAI-Y2 score</measure>
    <time_frame>at baseline and at 6 months</time_frame>
    <description>Association between the change in presenteeism and in anxiety after 6 months of biotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the change in the WPAI : Asthma- Q5 score and in the Nijmegen score</measure>
    <time_frame>at baseline and at 6 months</time_frame>
    <description>Association between the change in presenteeism and in hyperventilation symptoms after 6 months of biotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the change in the WPAI : Asthma- Q5 score and in the SNOT-22 score</measure>
    <time_frame>at baseline and at 6 months</time_frame>
    <description>Association between the change in presenteeism and in sino-nasal symptoms after 6 months of biotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the change in the WPAI : Asthma- Q5 score and in the AQLQ score</measure>
    <time_frame>at baseline and at 6 months</time_frame>
    <description>Association between the change in presenteeism and in quality of life after 6 months of biotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Correlation between the change in the WPAI : Asthma- Q5 score and in the daily dose of oral corticosteroids</measure>
    <time_frame>at baseline and at 6 months</time_frame>
    <description>Association between the change in presenteeism and in the daily dose of oral corticosteroids after 6 months of biotherapy</description>
  </secondary_outcome>
  <enrollment type="Anticipated">134</enrollment>
  <condition>Asthma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Severe asthmatic patients starting a biotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Severe asthma defined as the use of a high doses of inhaled corticosteroids combined&#xD;
             with a second controller (GINA 4) and / or oral corticosteroid therapy &gt; 50% of the&#xD;
             year&#xD;
&#xD;
          -  Eligible for biotherapy according to the investigator's decision&#xD;
&#xD;
          -  Holders of an employment contract for at least 8 days&#xD;
&#xD;
          -  Written non-opposition to participate in the study after information&#xD;
&#xD;
          -  Social protection affiliation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Existence of another chronic pulmonary disease (bronchiectasis, COPD, diffuse&#xD;
             interstitial lung disease, neuromuscular pathology, etc.) or cardiac (cardiac rhythm&#xD;
             disorder, ischemic heart disease, etc.) significant according to the investigator's&#xD;
             judgment&#xD;
&#xD;
          -  Psychiatric disorder&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Persons under guardianship&#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>Cécile Chenivesse, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cécile Chenivesse, MD,PhD</last_name>
    <phone>0320445962</phone>
    <phone_ext>+33</phone_ext>
    <email>cecile.chenivesse@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hop Calmette Chu Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>November 3, 2022</last_update_submitted>
  <last_update_submitted_qc>November 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Severe Asthma</keyword>
  <keyword>Presenteism</keyword>
  <keyword>Asthma burden</keyword>
  <keyword>Biotherapy</keyword>
  <keyword>Quality of life</keyword>
  <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>


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/NCT04463589
org study id: 2019_36
secondary id: 2020-A00085-34
nct id: NCT04463589
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Severe asthma is a condition characterized by a lower sensitivity to high doses of inhaled
      corticosteroids combined with a second controller, most often a long-acting bronchodilator.
      It concerns approximately 5% of asthmatics. Treatment failure and co-morbidities induced by
      systemic corticosteroid therapy can cause debilitating dyspnea, limited physical activity,
      and impaired quality of life. Severe asthma could therefore be associated with major
      presenteeism, defined as the presence of an employee at work despite his health issues and
      which implies a limitation of the employee's productive capacity. Uncontrolled asthma and
      co-morbidities of asthma have been shown to be associated with a decrease in work
      productivity that includes absenteeism and presenteeism. Although there is little data, a
      recent study found a decline in work productivity in severe asthma. Various factors
      associated with presenteeism could be involved, such as asthma control, frequency and
      severity of exacerbations, comorbidities, or treatments.

      Biotherapies targeting the signaling pathways involved in airway inflammation improve asthma
      control, decrease the frequency of asthma exacerbations which are major determinants of
      quality of life, improve lung function, and allow oral steroid sparing. Biotherapies could
      therefore be associated with a decrease in presenteeism.

      The objective of the study is to describe the evolution of presenteeism at work, evaluated by
      the WPAI: Asthma, after 6 months of treatment by biotherapy and to identify factors
      associated with this evolution
observational model: Case-Only
time perspective: Prospective
measure: Change in presenteeism
time frame: At 6 months
description: Change Questionnaire Work Productivity and activity impairment : Asthma (WPAI : Asthma) - question 5 (Q5) after 6 months of biotherapy The WPAI-question 5 ranges from 0 to 10, a higher score meaning a worse outcome
measure: Correlation between the WPAI : Asthma- Q5 score and the ACQ-6 score
time frame: at baseline
description: Association between presenteeism and asthma control Asthma Control Questionnaire (ACQ) is simple questionnaire to measure the adequacy of asthma control and change in asthma control, 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%)
measure: Correlation between the WPAI : Asthma- Q5 score and the mMRC score
time frame: at baseline
description: Association between presenteeism and exercise dyspnea at baseline the mMRC (Modified Medical Research Council) Dyspnea Scale,The 1-5 stage scale is used alongside the questionnaire to establish clinical grades of breathlessness.
measure: Correlation between the WPAI : Asthma- Q5 score and FEV1, la FVC and RV.
time frame: at baseline
description: Association between presenteeism and airways obstruction at baseline
measure: Correlation between the WPAI : Asthma- Q5 score and the STAI-Y2 score
time frame: at baseline
description: Association between presenteeism and anxiety at baseline tate-Trait Anxiety Inventory, STAI-Y2 (STAI-Y2), consists of 20 sentences assessing the subject's usual emotional state.Each answer to an item in the STAI-Y is scored from 1 to 4, with 1 indicating the lowest degree of anxiety and 4 the highest degree of anxiety.
measure: Correlation between the WPAI : Asthma- Q5 score and the Nijmegen score
time frame: at baseline
description: Association between presenteeism and hyperventilation symptoms at baseline
measure: Correlation between the WPAI : Asthma- Q5 score and the SNOT-22 score
time frame: at baseline
description: Association between presenteeism and sino-nasal symptoms at baseline
measure: Correlation between the WPAI : Asthma- Q5 score and the AQLQ score
time frame: at baseline
description: Association between presenteeism and quality of life at baseline
measure: Correlation between the WPAI : Asthma- Q5 score and the daily dose of oral corticosteroids
time frame: at baseline
description: Association between presenteeism and daily dose of oral corticosteroids at baseline
measure: Correlation between the WPAI : Asthma- Q5 score and the cumulative dose over 6 months of oral corticosteroids
time frame: at baseline
description: Association between presenteeism and cumulative dose over 6 months of oral corticosteroids at baseline
measure: Correlation between the change in the WPAI : Asthma- Q5 score and in the ACQ-6 score
time frame: at baseline and at 6 months
description: Association between the change in presenteeism and in asthma control after 6 months of biotherapy
measure: Correlation between the change in the WPAI : Asthma- Q5 score and in the mMRC score
time frame: at baseline and at 6 months
description: Association between the change in presenteeism and in exercise dyspnea after 6 months of biotherapy
measure: Correlation between the change in the WPAI : Asthma- Q5 score and in FEV1 and R5-R20
time frame: at baseline and at 6 months
description: Association between the change in presenteeism and in airways obstruction after 6 months of biotherapy
measure: Correlation between the change in the WPAI : Asthma- Q5 score and in the STAI-Y2 score
time frame: at baseline and at 6 months
description: Association between the change in presenteeism and in anxiety after 6 months of biotherapy
measure: Correlation between the change in the WPAI : Asthma- Q5 score and in the Nijmegen score
time frame: at baseline and at 6 months
description: Association between the change in presenteeism and in hyperventilation symptoms after 6 months of biotherapy
measure: Correlation between the change in the WPAI : Asthma- Q5 score and in the SNOT-22 score
time frame: at baseline and at 6 months
description: Association between the change in presenteeism and in sino-nasal symptoms after 6 months of biotherapy
measure: Correlation between the change in the WPAI : Asthma- Q5 score and in the AQLQ score
time frame: at baseline and at 6 months
description: Association between the change in presenteeism and in quality of life after 6 months of biotherapy
measure: • Correlation between the change in the WPAI : Asthma- Q5 score and in the daily dose of oral corticosteroids
time frame: at baseline and at 6 months
description: Association between the change in presenteeism and in the daily dose of oral corticosteroids after 6 months of biotherapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cécile Chenivesse, MD,PhD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Cécile Chenivesse, MD,PhD
phone: 0320445962
phone ext: +33
email: cecile.chenivesse@chru-lille.fr
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Asthma