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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

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


Condition or disease
Asthma

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Study Type : Observational
Estimated Enrollment : 134 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Factors Associated With the Evolution of Presenteeism Under Biotherapy in Severe Asthma
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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%)

  2. 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.

  3. 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

  4. 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.

  5. Correlation between the WPAI : Asthma- Q5 score and the Nijmegen score [ Time Frame: at baseline ]
    Association between presenteeism and hyperventilation symptoms at baseline

  6. 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

  7. Correlation between the WPAI : Asthma- Q5 score and the AQLQ score [ Time Frame: at baseline ]
    Association between presenteeism and quality of life at baseline

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. • 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Severe asthmatic patients starting a biotherapy
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04463589


Contacts
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Contact: Cécile Chenivesse, MD,PhD 0320445962 ext +33 cecile.chenivesse@chru-lille.fr

Locations
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France
Hop Calmette Chu Lille
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Cécile Chenivesse, MD,PhD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04463589    
Other Study ID Numbers: 2019_36
2020-A00085-34 ( Other Identifier: ID-RCB number,ANSM )
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Severe Asthma
Presenteism
Asthma burden
Biotherapy
Quality of life
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases