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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1256-9593 | Registry Identifier | ICTRP |
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Primary objective:
- Describe the characteristics of enrolled severe asthma patients
Secondary objectives:
52 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with severe asthma | Adolescents, for whom initiation of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was decided by the investigator before the inclusion in the study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Medical history (including history of asthma) | Relevant medical history other than asthma according to the investigator (including documented comorbidities associated with type 2 inflammation). Asthma history includes patient age at the time of diagnosis and family history. | At the start of treatment with Dupixent® (day 1) |
| Previous treatments for asthma | Background asthma treatments (doses and international nonproprietary name (INN) of inhaled corticosteroids (ICS), long-acting beta-2 agonist (LABA) and oral corticosteroids (OCS), etc) including cumulative yearly dose of OCS. Use of oral corticosteroids due to exacerbation of asthma (dose, INN). Use of emergency treatments (short-acting beta-2 agonist (SABA)) (number of times per week). | At the start of treatment with Dupixent® (day 1) |
| Demographic characteristics | Age and gender. | At the start of treatment with Dupixent® (day 1) |
| Disease characteristics | Disease characteristics at the inclusion including severity (Global Initiative for Asthma (GINA) step), number of severe exacerbations during the past year, number of days in intensive care unit (ICU) for severe exacerbation since the diagnosis, forced expiratory volume per second (FEV1), Asthma Control Test (ACT) score. | At the start of treatment with Dupixent® (day 1) |
| Concomitant medication | Relevant concomitant medication other than medication for asthma according to the investigator. | At the start of treatment with Dupixent® (day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 52 in asthma control test (ACT) score at each subsequent visit over the year of treatment | ACT score range: 5-25; higher score indicates better asthma control. | From baseline (day 1) to week 52 |
| Change from baseline to week 52 in number of annualized exacerbations and description of exacerbation setting |
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Inclusion Criteria:
Exclusion Criteria:
- Adult participants ≥ 18 years of age
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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Adolescents, for whom initiation of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was decided by the investigator before the inclusion in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site France | France | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41163372 | Result | Wanin S, Taam RA, Chami LG, Marguet C, Just J, Da Silva C, Msihid J, Ledanois O, Gall R, Sacks HJ, Jacob-Nara JA, Daridon C, Deschildre A. Characteristics of Adolescents With Uncontrolled Severe Asthma Starting Dupilumab: The PEDIASTHMA Registry. Allergy. 2026 Jan;81(1):292-296. doi: 10.1111/all.70119. Epub 2025 Oct 29. No abstract available. |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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An exacerbation is defined as deterioration of asthma requiring use of systemic corticosteroids for ≥3 days; or increase in oral corticosteroids (OCS) dose at ≥2 times the current dose for ≥3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. |
| From baseline (day 1) to week 52 |
| Change from baseline to week 52 in Paediatric Asthma Quality of Life Questionnaire (PAQLQ) score | Questionnaire including 23 questions in 3 domains (symptoms, activity limitation, emotional function) and a 7-point scale (7 = not bothered at all; 1 = extremely bothered). | From baseline (day 1) to week 52 |
| Change from baseline to week 52 in corticosteroid dose | Change in corticosteroid dose. | From baseline (day 1) to week 52 |
| Change from baseline to week 52 in pre- bronchodilator forced expiratory volume per second (FEV1) | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | From baseline (day 1) to week 52 |
| Change from baseline to week 52 in number of food allergic reactions | Following food allergic reactions will be recorded: allergic symptoms and anaphylaxis in real life or during an oral food challenge. | From baseline (day 1) to week 52 |
| Change from baseline to week 52 in in visual analogue scale (VAS) score for allergic rhinitis | VAS score range: 0 ('no symptoms') to 100 ('severe symptoms'). | From baseline (day 1) to week 52 |
| Change from baseline to week 52 in in Score for atopic dermatitis (SCORAD) score for atopic dermatitis | SCORAD is a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis as objectively as possible with scores ranging from 0-100. The higher the score indicates more severe atopic dermatitis. | From baseline (day 1) to week 52 |
| Change from baseline to week 52 in sinonasal symptoms of nasal polyposis of food allergies | Following sinonasal symptoms will be recorded: nasal congestion, loss in smell, posterior nasal discharge, anterior nasal discharge. | From baseline (day 1) to week 52 |
| Responder rates at week 52 for ACT (according to the minimal important difference (MID)) | A participant is defined as responder if he/she has a change from baseline of 3 points or more at week 52 on the ACT score. ACT score range: 5-25; higher score indicates better asthma control. | At week 52 |
| Responder rates at week 52 for PAQLQ (according to the MID)) | A participant is defined as responder if he/she has a change from baseline of 0.5 points or more at week 52 on the PAQLQ score. The PAQLQ(S) overall score is calculated by adding points of individual responses to all questions, with the higher scores indicating less impairment that is, a better quality of life. Questionnaire including 23 questions in 3 domains (symptoms, activity limitation, emotional function) and a 7-point scale (7 = not bothered at all; 1 = extremely bothered). | At week 52 |
| Reasons for Dupixent® discontinuation | All reasons for treatment discontinuation. | Day 1 to week 52 |
| Collection of adverse events | Number of adverse events. | Day 1 to week 52 |
| Collection of serious adverse events | Number of serious adverse events. | Day 1 to week 52 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |