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临床试验/NCT07637292
NCT07637292进行中(未招募)不适用

Use of Dupilumab in Asthma in Real-world Setting: Analysis of the SNDS Database

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 35,000 人开始时间: 2025年1月2日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
35,000
试验地点
1

研究概览

简要总结

The main objective of asthma pharmacological management in adults and teenagers is to maintain long-term control of the disease, including symptom relief, the prevention of exacerbations, the improvement of pulmonary function, the reduction of limitations in daily life and side effects of pharmacological treatments.

Dupilumab is a recombinant human monoclonal antibody that inhibits signalling of both IL-4 and IL-13, two Type 2 cytokines involved in inflammatory pathway. Dupixent obtained a European Marketing Authorization in September 2017 and was reimbursed in France from March 5, 2019 in adults with moderate-to-severe atopic dermatitis. On November 10, 2020, the reimbursement of Dupixent was extended to adults and adolescents aged 12 and over as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils (≥ 0.150 g/L) and/or raised fraction of exhaled nitric oxide (FeNO ≥ 20 ppb), who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Lastly, on July 22, 2021, Dupixent was also reimbursed in patients with severe nasal polyposis.

Primary objective: To describe the characteristics of patients using dupilumab for severe asthma in a real-world setting.

Secondary objectives:

  • To describe the Health Care Resource Use (HCRU) and associated costs of severe asthmatic patients using dupilumab.
  • To describe the use of corticosteroids (oral and inhaled) before and after dupilumab initiation.
  • To study persistence with dupilumab in real-world

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least one reimbursement of dupilumab during the inclusion period from November 10, 2020 to December 31, 2023
  • At least one of the following asthma markers:
  • at least one reimbursement of inhaled corticosteroids (ICS and fixed-dose combination ICS/LABA inhalers) in a 3-month time-window before and after one of the reimbursement of dupilumab
  • A Long-Term Disease (LTD) for asthma in the 12 months before dupilumab initiation or over follow-up.
  • An hospital admission for asthma in the 12 months before dupilumab initiation or over follow-up.

排除标准

  • 未提供

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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