Presenteeism in Severe Asthma Treated by Biotherapyasthma

Asthma Clinical Trial

— PRESATHMA  

Official title:

Factors Associated With the Evolution of Presenteeism Under Biotherapy in Severe Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04463589
• Other study ID #: 2019_36
• Secondary ID: 2020-A00085-34
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: January 2023

Study information

• Verified date: November 2022
• Source: University Hospital, Lille
• Contact: Cécile Chenivesse, MD,PhD
• Phone: 0320445962
• Email: cecile.chenivesse[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
France	Hop Calmette Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in presenteeism	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	At 6 months
Secondary	Correlation between the WPAI : Asthma- Q5 score and the ACQ-6 score	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%)	at baseline
Secondary	Correlation between the WPAI : Asthma- Q5 score and the mMRC score	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.	at baseline
Secondary	Correlation between the WPAI : Asthma- Q5 score and FEV1, la FVC and RV.	Association between presenteeism and airways obstruction at baseline	at baseline
Secondary	Correlation between the WPAI : Asthma- Q5 score and the STAI-Y2 score	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.	at baseline
Secondary	Correlation between the WPAI : Asthma- Q5 score and the Nijmegen score	Association between presenteeism and hyperventilation symptoms at baseline	at baseline
Secondary	Correlation between the WPAI : Asthma- Q5 score and the SNOT-22 score	Association between presenteeism and sino-nasal symptoms at baseline	at baseline
Secondary	Correlation between the WPAI : Asthma- Q5 score and the AQLQ score	Association between presenteeism and quality of life at baseline	at baseline
Secondary	Correlation between the WPAI : Asthma- Q5 score and the daily dose of oral corticosteroids	Association between presenteeism and daily dose of oral corticosteroids at baseline	at baseline
Secondary	Correlation between the WPAI : Asthma- Q5 score and the cumulative dose over 6 months of oral corticosteroids	Association between presenteeism and cumulative dose over 6 months of oral corticosteroids at baseline	at baseline
Secondary	Correlation between the change in the WPAI : Asthma- Q5 score and in the ACQ-6 score	Association between the change in presenteeism and in asthma control after 6 months of biotherapy	at baseline and at 6 months
Secondary	Correlation between the change in the WPAI : Asthma- Q5 score and in the mMRC score	Association between the change in presenteeism and in exercise dyspnea after 6 months of biotherapy	at baseline and at 6 months
Secondary	Correlation between the change in the WPAI : Asthma- Q5 score and in FEV1 and R5-R20	Association between the change in presenteeism and in airways obstruction after 6 months of biotherapy	at baseline and at 6 months
Secondary	Correlation between the change in the WPAI : Asthma- Q5 score and in the STAI-Y2 score	Association between the change in presenteeism and in anxiety after 6 months of biotherapy	at baseline and at 6 months
Secondary	Correlation between the change in the WPAI : Asthma- Q5 score and in the Nijmegen score	Association between the change in presenteeism and in hyperventilation symptoms after 6 months of biotherapy	at baseline and at 6 months
Secondary	Correlation between the change in the WPAI : Asthma- Q5 score and in the SNOT-22 score	Association between the change in presenteeism and in sino-nasal symptoms after 6 months of biotherapy	at baseline and at 6 months
Secondary	Correlation between the change in the WPAI : Asthma- Q5 score and in the AQLQ score	Association between the change in presenteeism and in quality of life after 6 months of biotherapy	at baseline and at 6 months
Secondary	• Correlation between the change in the WPAI : Asthma- Q5 score and in the daily dose of oral corticosteroids	Association between the change in presenteeism and in the daily dose of oral corticosteroids after 6 months of biotherapy	at baseline and at 6 months