Clinical trial NCT04463589: Presenteeism in Severe Asthma Treated by Biotherapyasthma
Official title: Factors Associated With the Evolution of Presenteeism Under Biotherapy in Severe Asthma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Keywords: Severe Asthma
Presenteism
Asthma burden
Biotherapy
Quality of life
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe asthmatic patients starting a biotherapy

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


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

Primary outcomes:
measure: Change in presenteeism
timeFrame: At 6 months
Secondary outcomes:
measure: Correlation between the WPAI : Asthma- Q5 score and the ACQ-6 score
timeFrame: at baseline
measure: Correlation between the WPAI : Asthma- Q5 score and the mMRC score
timeFrame: at baseline
measure: Correlation between the WPAI : Asthma- Q5 score and FEV1, la FVC and RV.
timeFrame: at baseline
measure: Correlation between the WPAI : Asthma- Q5 score and the STAI-Y2 score
timeFrame: at baseline
measure: Correlation between the WPAI : Asthma- Q5 score and the Nijmegen score
timeFrame: at baseline
measure: Correlation between the WPAI : Asthma- Q5 score and the SNOT-22 score
timeFrame: at baseline
measure: Correlation between the WPAI : Asthma- Q5 score and the AQLQ score
timeFrame: at baseline
measure: Correlation between the WPAI : Asthma- Q5 score and the daily dose of oral corticosteroids
timeFrame: at baseline
measure: Correlation between the WPAI : Asthma- Q5 score and the cumulative dose over 6 months of oral corticosteroids
timeFrame: at baseline
measure: Correlation between the change in the WPAI : Asthma- Q5 score and in the ACQ-6 score
timeFrame: at baseline and at 6 months
measure: Correlation between the change in the WPAI : Asthma- Q5 score and in the mMRC score
timeFrame: at baseline and at 6 months
measure: Correlation between the change in the WPAI : Asthma- Q5 score and in FEV1 and R5-R20
timeFrame: at baseline and at 6 months
measure: Correlation between the change in the WPAI : Asthma- Q5 score and in the STAI-Y2 score
timeFrame: at baseline and at 6 months
measure: Correlation between the change in the WPAI : Asthma- Q5 score and in the Nijmegen score
timeFrame: at baseline and at 6 months
measure: Correlation between the change in the WPAI : Asthma- Q5 score and in the SNOT-22 score
timeFrame: at baseline and at 6 months
measure: Correlation between the change in the WPAI : Asthma- Q5 score and in the AQLQ score
timeFrame: at baseline and at 6 months
measure: • Correlation between the change in the WPAI : Asthma- Q5 score and in the daily dose of oral corticosteroids
timeFrame: at baseline and at 6 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Calmette Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Cécile Chenivesse, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: