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Use of Dupilumab in Asthma in Real-world Setting

NCT07637292 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 35000

Last updated 2026-06-09

No results posted yet for this study

Summary

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

Conditions

  • Asthma Acute

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2026-09-01
Completion
2026-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07637292 on ClinicalTrials.gov