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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Primary Objective:
The primary objective of the study is to characterize patients initiating DUPIXENT for asthma in a real-world setting, with respect to their medical history, including asthma history and asthma treatment history, socio-demographic, biomarkers (including Fractional exhaled nitric oxide [FeNO]), and concomitant treatments for asthma.
Secondary Objectives:
The secondary objectives of the study are:
Each patient will be followed for up to 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with asthma | Eligible participants are initiating treatment with Dupixent for asthma according to the prescribing information in effect in each country |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab SAR231893 | Drug | Pharmaceutical form:solution Route of administration: subcutaneous Dose regimen: |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Characteristics: Socio-demographics | Socio-demographics including but not limited to gender, age, race, weight, and height | At baseline |
| Baseline Characteristics: Medical history | Including asthma history and asthma treatment history | At baseline |
| Baseline Characteristics: Disease characteristics | Disease characteristics including asthma, comorbid conditions, family history and history of inflammatory diseases | At baseline |
| Baseline Characteristics: Biomarkers | Including fractional exhaled nitric oxide (FeNo), blood eosinophils count, immunoglobulin E (IgE total/specific) | At baseline |
| Baseline Characteristics: Concomitant treatments for asthma | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Dupixent and other asthma treatment use patterns | Including doses and dose frequency, treatment duration, asthma treatment associations (eg, Dupixent monotherapy, Dupixent + inhaled corticosteroids (ICS), Dupixent + ICS + additional controllers, oral corticosteroid (OCS) burst), and reasons for initiation and for discontinuation/switching. | Baseline to Month 36 |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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Patients with asthma initiating DUPIXENT for their asthma according to the prescribing information in effect in each country.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number : 0320005 | La Plata | Buenos Aires | B1900BNN | Argentina | ||
| Investigational Site Number : 0320006 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42268495 | Derived | Maspero JF, Arnaout RK, Vargas-Ramirez L, Mobayed H, Mahboub B, Irani C, Bar-Shai A, Koh MS, Chao J, Zaghloul S, Kwah JH, Dewhurst J, Al-Ahmad MS. Baseline Characteristics of Patients with Asthma Initiating Dupilumab in a Real-World Setting: The REVEAL Registry. Adv Ther. 2026 Jun 10. doi: 10.1007/s12325-026-03623-2. Online ahead of print. |
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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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| Lung function | Pre and post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) over time. | Baseline to Month 36 |
| Annualized exacerbation rate | A severe exacerbation event is defined as a deterioration of asthma requiring:
| Baseline to Month 36 |
| Patient reported outcomes: Asthma Control Questionnaire (6-item) (ACQ-6) | To evaluate asthma control | Baseline to Month 36 |
| Patient reported outcomes: Patient Oriented Eczema Measure (POEM) among participants with atopic dermatitis | Among participants with atopic dermatitis | Baseline to Month 36 |
| Patient reported outcomes: Allergic Rhinitis Visual Analogue Scale (AR-VAS) among participants with allergic rhinitis | Among participants with allergic rhinitis | Baseline to Month 36 |
| Patient reported outcomes: Sino-nasal Outcome Test (SNOT-22) | Among participants with chronic rhinosinusitis with nasal polyps [CRSwNP] and chronic rhinosinusitis [CRS] without nasal polyps [NP]) | Baseline to Month 36 |
| Healthcare Resource Utilization | The Healthcare Resource Utilization (HCRU) collects information on unscheduled healthcare resource encounters including inpatient visits, emergency room visits, physician office visits related to asthma, including the dates of visits and duration of any hospitalizations, together with the reason for the visits | Baseline to Month 36 |
| Number of participants with adverse events (AE) and serious adverse events (SAE) | Baseline to Month 36 |
| Villa Rosa |
| Buenos Aires |
| 1631 |
| Argentina |
| Investigational Site Number : 0320001 | Ciudad Autonoma Bs As | C1121ABE | Argentina |
| Investigational Site Number : 0320008 | Ciudad Autonoma Buenos Aires | C1425BEN | Argentina |
| Investigational Site Number : 0320009 | San Miguel de Tucumán | T4000IAI | Argentina |
| Investigational Site Number : 0320004 | Santa Fe | 3000 | Argentina |
| Investigational Site Number : 1520001 | Santiago | Reg Metropolitana de Santiago | 7500692 | Chile |
| Investigational Site Number : 1520002 | Quillota | Valparaiso | 2260877 | Chile |
| Investigational Site Number : 1700009 | Barranquilla | 080001 | Colombia |
| Investigational Site Number : 1700004 | Bogotá | Colombia |
| Investigational Site Number : 1700003 | Bucaramanga | Colombia |
| Investigational Site Number : 3760008 | Ashdod | 7747629 | Israel |
| Investigational Site Number : 3760004 | Ashkelon | 78278 | Israel |
| Investigational Site Number : 3760005 | Jerusalem | 91031 | Israel |
| Investigational Site Number : 3760003 | Jerusalem | 91120 | Israel |
| Investigational Site Number : 3760001 | Kfar Saba | 4428164 | Israel |
| Investigational Site Number : 3760006 | Rehovot | 7642001 | Israel |
| Investigational Site Number : 3760007 | Tel Aviv | 64239 | Israel |
| Investigational Site Number : 4140001 | Kuwait City | 00000 | Kuwait |
| Investigational Site Number : 4220002 | Beirut | 11 0236 | Lebanon |
| Investigational Site Number : 4220001 | Beirut | Lebanon |
| Investigational Site Number : 4220003 | El Achrafiyé | Lebanon |
| Investigational Site Number : 4840003 | Durango | 34000 | Mexico |
| Investigational Site Number : 6340001 | Doha | Qatar |
| Investigational Site Number : 6430005 | Chelyabinsk | 454091 | Russia |
| Investigational Site Number : 6430007 | Moscow | 105077 | Russia |
| Investigational Site Number : 6430004 | Moscow | 115522 | Russia |
| Investigational Site Number : 6430006 | Rostov-on-Don | 344012 | Russia |
| Investigational Site Number : 6430008 | Saratov | 410012 | Russia |
| Investigational Site Number : 6430002 | Stavropol | 355020 | Russia |
| Investigational Site Number : 6820005 | Jeddah | 23433 | Saudi Arabia |
| Investigational Site Number : 6820004 | Mecca | 24246 | Saudi Arabia |
| Investigational Site Number : 6820002 | Riyadh | 11525 | Saudi Arabia |
| Investigational Site Number : 6820001 | Riyadh | 12713 | Saudi Arabia |
| Investigational Site Number : 7020002 | Singapore | 119074 | Singapore |
| Investigational Site Number : 7020001 | Singapore | 169308 | Singapore |
| Investigational Site Number : 7840006 | Abu Dhabi | 0000 | United Arab Emirates |
| Investigational Site Number : 7840007 | Dubai | 2 | United Arab Emirates |
| Investigational Site Number : 7840001 | Dubai | 4545 | United Arab Emirates |
| Investigational Site Number : 7840004 | Sharjah city | 00000 | United Arab Emirates |
| Investigational Site Number : 7840002 | Sharjah city | 3499 | United Arab Emirates |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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