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Presenteeism in Severe Asthma Treated by Biotherapyasthma (PRESATHMA)

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ClinicalTrials.gov Identifier: NCT04463589
Recruitment Status : Not yet recruiting
First Posted : July 9, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date July 2, 2020
First Posted Date July 9, 2020
Last Update Posted Date November 18, 2020
Estimated Study Start Date January 1, 2021
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2020)
Change in presenteeism [ Time Frame: At 6 months ]
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
Original Primary Outcome Measures
 (submitted: July 3, 2020)
Change in presenteeism [ Time Frame: At 6 months ]
Change Questionnaire Work Productivity and activity impairment : Asthma (WPAI : Asthma) - question 5 (Q5) after 6 months of biotherapy
Change History
Current Secondary Outcome Measures
 (submitted: July 3, 2020)
  • Correlation between the WPAI : Asthma- Q5 score and the ACQ-6 score [ Time Frame: at baseline ]
    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%)
  • Correlation between the WPAI : Asthma- Q5 score and the mMRC score [ Time Frame: at baseline ]
    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.
  • Correlation between the WPAI : Asthma- Q5 score and FEV1, la FVC and RV. [ Time Frame: at baseline ]
    Association between presenteeism and airways obstruction at baseline
  • Correlation between the WPAI : Asthma- Q5 score and the STAI-Y2 score [ Time Frame: at baseline ]
    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.
  • Correlation between the WPAI : Asthma- Q5 score and the Nijmegen score [ Time Frame: at baseline ]
    Association between presenteeism and hyperventilation symptoms at baseline
  • Correlation between the WPAI : Asthma- Q5 score and the SNOT-22 score [ Time Frame: at baseline ]
    Association between presenteeism and sino-nasal symptoms at baseline
  • Correlation between the WPAI : Asthma- Q5 score and the AQLQ score [ Time Frame: at baseline ]
    Association between presenteeism and quality of life at baseline
  • Correlation between the WPAI : Asthma- Q5 score and the daily dose of oral corticosteroids [ Time Frame: at baseline ]
    Association between presenteeism and daily dose of oral corticosteroids at baseline
  • Correlation between the WPAI : Asthma- Q5 score and the cumulative dose over 6 months of oral corticosteroids [ Time Frame: at baseline ]
    Association between presenteeism and cumulative dose over 6 months of oral corticosteroids at baseline
  • Correlation between the change in the WPAI : Asthma- Q5 score and in the ACQ-6 score [ Time Frame: at baseline and at 6 months ]
    Association between the change in presenteeism and in asthma control after 6 months of biotherapy
  • Correlation between the change in the WPAI : Asthma- Q5 score and in the mMRC score [ Time Frame: at baseline and at 6 months ]
    Association between the change in presenteeism and in exercise dyspnea after 6 months of biotherapy
  • Correlation between the change in the WPAI : Asthma- Q5 score and in FEV1 and R5-R20 [ Time Frame: at baseline and at 6 months ]
    Association between the change in presenteeism and in airways obstruction after 6 months of biotherapy
  • Correlation between the change in the WPAI : Asthma- Q5 score and in the STAI-Y2 score [ Time Frame: at baseline and at 6 months ]
    Association between the change in presenteeism and in anxiety after 6 months of biotherapy
  • Correlation between the change in the WPAI : Asthma- Q5 score and in the Nijmegen score [ Time Frame: at baseline and at 6 months ]
    Association between the change in presenteeism and in hyperventilation symptoms after 6 months of biotherapy
  • Correlation between the change in the WPAI : Asthma- Q5 score and in the SNOT-22 score [ Time Frame: at baseline and at 6 months ]
    Association between the change in presenteeism and in sino-nasal symptoms after 6 months of biotherapy
  • Correlation between the change in the WPAI : Asthma- Q5 score and in the AQLQ score [ Time Frame: at baseline and at 6 months ]
    Association between the change in presenteeism and in quality of life after 6 months of biotherapy
  • • 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 ]
    Association between the change in presenteeism and in the daily dose of oral corticosteroids after 6 months of biotherapy
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Presenteeism in Severe Asthma Treated by Biotherapyasthma
Official Title Factors Associated With the Evolution of Presenteeism Under Biotherapy in Severe Asthma
Brief Summary

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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Severe asthmatic patients starting a biotherapy
Condition Asthma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 3, 2020)
134
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Severe asthma defined as the use of a high doses of inhaled corticosteroids combined with a second controller (GINA 4) and / or oral corticosteroid therapy > 50% of the year
  • Eligible for biotherapy according to the investigator's decision
  • Holders of an employment contract for at least 8 days
  • Written non-opposition to participate in the study after information
  • Social protection affiliation

Exclusion Criteria:

  • Existence of another chronic pulmonary disease (bronchiectasis, COPD, diffuse interstitial lung disease, neuromuscular pathology, etc.) or cardiac (cardiac rhythm disorder, ischemic heart disease, etc.) significant according to the investigator's judgment
  • Psychiatric disorder
  • Pregnancy
  • Persons under guardianship
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Cécile Chenivesse, MD,PhD 0320445962 ext +33 cecile.chenivesse@chru-lille.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04463589
Other Study ID Numbers 2019_36
2020-A00085-34 ( Other Identifier: ID-RCB number,ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Not Provided
Investigators
Principal Investigator: Cécile Chenivesse, MD,PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date November 2020