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Presenteeism in Severe Asthma Treated by Biotherapyasthma (PRESATHMA)

2022年11月3日 更新者:University Hospital, Lille

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

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (预期的)

134

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Lille、法国
        • 招聘中
        • Hop Calmette Chu Lille

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Severe asthmatic patients starting a biotherapy

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in presenteeism
大体时间: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
At 6 months

次要结果测量

结果测量
措施说明
大体时间
Correlation between the WPAI : Asthma- Q5 score and the ACQ-6 score
大体时间: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%)
at baseline
Correlation between the WPAI : Asthma- Q5 score and the mMRC score
大体时间: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.
at baseline
Correlation between the WPAI : Asthma- Q5 score and FEV1, la FVC and RV.
大体时间:at baseline
Association between presenteeism and airways obstruction at baseline
at baseline
Correlation between the WPAI : Asthma- Q5 score and the STAI-Y2 score
大体时间: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.
at baseline
Correlation between the WPAI : Asthma- Q5 score and the Nijmegen score
大体时间:at baseline
Association between presenteeism and hyperventilation symptoms at baseline
at baseline
Correlation between the WPAI : Asthma- Q5 score and the SNOT-22 score
大体时间:at baseline
Association between presenteeism and sino-nasal symptoms at baseline
at baseline
Correlation between the WPAI : Asthma- Q5 score and the AQLQ score
大体时间:at baseline
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
大体时间:at baseline
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
大体时间:at baseline
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
大体时间:at baseline and at 6 months
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
大体时间:at baseline and at 6 months
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
大体时间:at baseline and at 6 months
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
大体时间:at baseline and at 6 months
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
大体时间:at baseline and at 6 months
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
大体时间:at baseline and at 6 months
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
大体时间:at baseline and at 6 months
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
大体时间: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
at baseline and at 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年1月1日

初级完成 (预期的)

2023年1月1日

研究完成 (预期的)

2023年1月1日

研究注册日期

首次提交

2020年7月2日

首先提交符合 QC 标准的

2020年7月3日

首次发布 (实际的)

2020年7月9日

研究记录更新

最后更新发布 (实际的)

2022年11月4日

上次提交的符合 QC 标准的更新

2022年11月3日

最后验证

2022年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2019_36
  • 2020-A00085-34 (其他标识符:ID-RCB number,ANSM)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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