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AsthmaPRESATHMANCT04463589

Presenteeism in Severe Asthma Treated by Biotherapyasthma

An observational study of Asthma, run by University Hospital, Lille at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
How many people
174 participants
Where
1 siteFrance
Study dates
1 Jan 2021to 10 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Severe asthmatic patients starting a biotherapy

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hop Calmette Chu Lille

    Lille

Other trials in France

About this study

Official title: 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

Conditions
Asthma
Keywords
Severe Asthma, Presenteism, Asthma burden, Biotherapy, Quality of life
Medical subject headings
Asthma

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At 6 months

Secondary outcomes (17)

  1. 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%)

    Measured: at baseline

  2. 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.

    Measured: at baseline

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

    Association between presenteeism and airways obstruction at baseline

    Measured: at baseline

  4. 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.

    Measured: at baseline

  5. Correlation between the WPAI : Asthma- Q5 score and the Nijmegen score

    Association between presenteeism and hyperventilation symptoms at baseline

    Measured: at baseline

  6. Correlation between the WPAI : Asthma- Q5 score and the SNOT-22 score

    Association between presenteeism and sino-nasal symptoms at baseline

    Measured: at baseline

  7. Correlation between the WPAI : Asthma- Q5 score and the AQLQ score

    Association between presenteeism and quality of life at baseline

    Measured: at baseline

  8. 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

    Measured: at baseline

  9. 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

    Measured: at baseline

  10. 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

    Measured: at baseline and at 6 months

  11. 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

    Measured: at baseline and at 6 months

  12. 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

    Measured: at baseline and at 6 months

  13. 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

    Measured: at baseline and at 6 months

  14. 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

    Measured: at baseline and at 6 months

  15. 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

    Measured: at baseline and at 6 months

  16. 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

    Measured: at baseline and at 6 months

  17. • 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

    Measured: at baseline and at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2020
  2. Study start1 Jan 2021
  3. Primary completion10 Jun 2024
  4. Study completion10 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04463589
Sponsor's protocol ID
2019_36
Other IDs
2020-A00085-34
Acronym
PRESATHMA
Status last verified
Dec 2023
First submitted
2 Jul 2020
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by University Hospital, Lille at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in presenteeism (time frame: At 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04463589.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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