Asthma AcuteDUPILUMABNCT07637292
Use of Dupilumab in Asthma in Real-world Setting
An observational study of Asthma Acute, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma Acute
- How many people
- 35,000 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2025to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: For this study, we will use the data from the SNDS database. This is the French claims database, which contains all information related to public and private healthcare reimbursements from various regimens in France. It includes all non-hospital reimbursed healthcare expenditures. In 2019, SNIIRAM covered 98.8% of the French population. It also contains demographic characteristics (age, sex, vital status), information on healthcare professionals, presence of chronic condition with ICD-10 codes, as well as information on date and nature of medical and paramedical interventions, laboratory tests, medical transportations, and number of days of paid sick leaves. These data are linked to the hospital discharge ICD-10 diagnoses codes for all medical, obstetric, and surgery hospitalizations, medical procedures, hospitalization department, and cost coding system. Data are also linked to the national deaths database for medical causes of death.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Dupilumab in Asthma in Real-world Setting: Analysis of the SNDS Database
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.
Read more
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
- Keywords
- Recombinant human monoclonal antibody, SNDS database, Real-life setting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | * Patients will be included in the study if they meet the following inclusion criteria: * At least one reimbursement of dupilumab during the inclusion period from November 10, 2020 to December 31, 2023 AND * Be 12 years or older at dupilumab initiation. AND * 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. Two subgroups: 12 to 18 y.o. subgroup vs. 18 and+ y.o. subgroup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's characteristics
Age at index date
- Sex
- Affiliation of Complementary universal healthcare coverage (CMU-C)
- Comorbidities in the 12 months before dupilumab initiation, from diagnoses recorded during hospitalization or LTD status and medications :
- Diabetes
- Cardiovascular diseases
- disabling stroke,
- chronic arterial diseases,
- heart failure, arrhythmias, valvular and severe congenital heart disease,
- severe hypertension,
- coronary heart disease,
- Mental illness, including depression/anxiety
- Eosinophilic Esophagitis
- Nodular prurigo
- Atopic dermatitis
- Osteoporosis
The characteristics of patients will be described in the overall cohort and in age subgroups ([12-18[ and ≥ 18 years old).
Measured: At index date, i.e. at the date of the 1st reimbursement of Dupilumab over the inclusion period (betw Nov 10, 2020 and Dec 31, 2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start2 Jan 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Asthma AcuteStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637292
- Sponsor's protocol ID
- 69HCL24_0491
- Other IDs
- 26-5238
- Acronym
- DUPILUMAB
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tuppin P, Rudant J, Constantinou P, Gastaldi-Menager C, Rachas A, de Roquefeuil L, Maura G, Caillol H, Tajahmady A, Coste J, Gissot C, Weill A, Fagot-Campagna A. Value of a national administrative database to guide public decisions: From the systeme national d'information interregimes de l'Assurance Maladie (SNIIRAM) to the systeme national des donnees de sante (SNDS) in France. Rev Epidemiol Sante Publique. 2017 Oct;65 Suppl 4:S149-S167. doi: 10.1016/j.respe.2017.05.004. Epub 2017 Jul 27.
PubMed 28756037Rabe KF, Nair P, Brusselle G, Maspero JF, Castro M, Sher L, Zhu H, Hamilton JD, Swanson BN, Khan A, Chao J, Staudinger H, Pirozzi G, Antoni C, Amin N, Ruddy M, Akinlade B, Graham NMH, Stahl N, Yancopoulos GD, Teper A. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. N Engl J Med. 2018 Jun 28;378(26):2475-2485. doi: 10.1056/NEJMoa1804093. Epub 2018 May 21.
PubMed 29782224Busse WW, Maspero JF, Rabe KF, Papi A, Wenzel SE, Ford LB, Pavord ID, Zhang B, Staudinger H, Pirozzi G, Amin N, Akinlade B, Eckert L, Chao J, Graham NMH, Teper A. Liberty Asthma QUEST: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Dupilumab Efficacy/Safety in Patients with Uncontrolled, Moderate-to-Severe Asthma. Adv Ther. 2018 May;35(5):737-748. doi: 10.1007/s12325-018-0702-4. Epub 2018 May 3.
PubMed 29725983