NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Use of Dupilumab in Asthma in Real-world Setting

Active Not RecruitingN/A

Sponsor: Hospices Civils de Lyon

Conditions: Asthma Acute

Countries: France

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

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

\-

Locations (1)

Lyon, France