Presenteeism in Severe Asthma Treated by Biotherapyasthma (PRESATHMA)

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

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

Study Overview

• Status: Recruiting
• Conditions: Asthma

• Study Type: Observational
• Enrollment (Anticipated): 134

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Recruiting
    • Hop Calmette Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Severe asthmatic patients starting a biotherapy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Correlation between the WPAI : Asthma- Q5 score and FEV1, la FVC and RV.	Association between presenteeism and airways obstruction at baseline	at baseline
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
Correlation between the WPAI : Asthma- Q5 score and the Nijmegen score	Association between presenteeism and hyperventilation symptoms at baseline	at baseline
Correlation between the WPAI : Asthma- Q5 score and the SNOT-22 score	Association between presenteeism and sino-nasal symptoms at baseline	at baseline
Correlation between the WPAI : Asthma- Q5 score and the AQLQ score	Association between presenteeism and quality of life at baseline	at baseline
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
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
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
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
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
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
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
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
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
• 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

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; Severe Asthma; Biotherapy; Presenteism; Asthma burden
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2019_36; 2020-A00085-34 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No