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Presenteeism in Severe Asthma Treated by Biotherapyasthma (PRESATHMA)

2022년 11월 3일 업데이트: 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

연구 개요

상태

모병

정황

연구 유형

관찰

등록 (예상)

134

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Lille, 프랑스
        • 모병
        • Hop Calmette Chu Lille

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Severe asthmatic patients starting a biotherapy

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in presenteeism
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Correlation between the WPAI : Asthma- Q5 score and the ACQ-6 score
기간: 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
기간: 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.
기간: at baseline
Association between presenteeism and airways obstruction at baseline
at baseline
Correlation between the WPAI : Asthma- Q5 score and the STAI-Y2 score
기간: 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
기간: at baseline
Association between presenteeism and hyperventilation symptoms at baseline
at baseline
Correlation between the WPAI : Asthma- Q5 score and the SNOT-22 score
기간: at baseline
Association between presenteeism and sino-nasal symptoms at baseline
at baseline
Correlation between the WPAI : Asthma- Q5 score and the AQLQ score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 1월 1일

기본 완료 (예상)

2023년 1월 1일

연구 완료 (예상)

2023년 1월 1일

연구 등록 날짜

최초 제출

2020년 7월 2일

QC 기준을 충족하는 최초 제출

2020년 7월 3일

처음 게시됨 (실제)

2020년 7월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 11월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 11월 3일

마지막으로 확인됨

2022년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2019_36
  • 2020-A00085-34 (기타 식별자: ID-RCB number,ANSM)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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