Presenteeism in Severe Asthma Treated by Biotherapyasthma

NCT04463589 | Completed

• 2 other identifiers: 2019_362020-A00085-34
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

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

Conditions

Asthma

Keywords

Severe Asthma; Presenteism; Asthma burden; Biotherapy; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Correlation between the WPAI : Asthma- Q5 score and the ACQ-6 score

  at baseline

• Correlation between the WPAI : Asthma- Q5 score and the mMRC score

  at baseline

• Correlation between the WPAI : Asthma- Q5 score and FEV1, la FVC and RV.

  at baseline

• Correlation between the WPAI : Asthma- Q5 score and the STAI-Y2 score

  at baseline

• Correlation between the WPAI : Asthma- Q5 score and the Nijmegen score

  at baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Severe asthmatic patients starting a biotherapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Calmette Chu Lille

Lille, France

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Cécile Chenivesse, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 9, 2020
• Study Start: January 1, 2021
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: December 23, 2025

Record last verified: 2023-12

Locations

FR (1)