Presenteeism in Severe Asthma Treated by Biotherapyasthma

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University Hospital, Lille

临床试验: NCT04463589

BioSeek: nct04463589

关键词

抽象

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

日期

最后验证:	06/30/2020
首次提交:	07/01/2020
提交的预估入学人数:	07/02/2020
首次发布:	07/08/2020
上次提交的更新:	07/07/2020
最近更新发布:	07/09/2020
实际学习开始日期:	08/31/2020
预计主要完成日期:	08/31/2022
预计完成日期:	08/31/2022

状况或疾病

Asthma

相

资格标准

有资格学习的年龄	18 Years 至 18 Years
有资格学习的性别	All
取样方式	Non-Probability Sample
接受健康志愿者	是
标准	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

结果

主要结果指标

1. Change in presenteeism [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

次要成果指标

1. Correlation between the WPAI : Asthma- Q5 score and the ACQ-6 score [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 [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. [at baseline]

Association between presenteeism and airways obstruction at baseline

4. Correlation between the WPAI : Asthma- Q5 score and the STAI-Y2 score [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 [at baseline]

Association between presenteeism and hyperventilation symptoms at baseline

6. Correlation between the WPAI : Asthma- Q5 score and the SNOT-22 score [at baseline]

Association between presenteeism and sino-nasal symptoms at baseline

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

Presenteeism in Severe Asthma Treated by Biotherapyasthma

关键词

inflammation

asthma

dyspnea

抽象

日期

状况或疾病

相

资格标准

结果

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