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Completed

NCT Number: NCT04463589

Presenteeism in Severe Asthma Treated by Biotherapyasthma

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Calmette Chu Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: PRESATHMA

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2020
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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