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| ID | Type | Description | Link |
|---|---|---|---|
| 46244 | Registry Identifier | EU HMA-EMA Catalogues | |
| EUPAS41963 | Other Identifier | ENCePP |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The primary objective of the study is to characterize the patients who initiate treatment for asthma with DUPIXENT® in a real-world setting to understand the attributes of treated patients in real life.
This includes characterization of:
The secondary objectives of the study are:
3-year registry of real-world use of DUPIXENT® for asthma in patients age 12 and over
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DUPIXENT® | Drug | There is no investigational product provided by the study sponsor and no therapeutic intervention regulated by this protocol. As a condition for eligibility, patients are required to initiate DUPIXENT® for asthma, according to the country-specific prescribing information, prescribed by their physician as part of their normal care (ie, not for the purpose of enrolling in the registry). Once patients enter the study, there are no protocol requirements regarding DUPIXENT® or any other treatments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demography | Including gender, age, race | At Baseline |
| Baseline Characteristics | Including prior medications and procedures, medical history, asthma history, weight, height | At Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Treatment Characteristics | Including but not limited to treatment dose, frequency, duration and asthma treatment associations. | At Baseline |
| Incidence of adverse events (AEs) | Including but not limited to: frequency, percentage and exposure-adjusted incidence rate of AEs |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
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The target population comprises adult and adolescent patients (male or female, ≥12 years old), who are initiating treatment with DUPIXENT® for asthma according to the country-specific prescribing information.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Alabama, LLC | Birmingham | Alabama | 35209 | United States | ||
| Arizona Allergy & Immunology Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42060163 | Derived | Peters AT, Cote A, Munoz X, Xia C, Nash S, Hardin M, de Prado Gomez L, Sacks HJ, Jacob-Nara JA, Rowe PJ, Deniz Y. Coexisting Type 2 Inflammatory Conditions in Patients with Asthma Treated with Dupilumab: the RAPID Registry. Adv Ther. 2026 Apr 30. doi: 10.1007/s12325-026-03568-6. Online ahead of print. | |
| 36626107 | Derived |
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| Baseline up to 3 years |
| Physician Assessment: - Spirometry | Assessment collected as per standard of care. Includes forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF), forced vital capacity (FVC), forced expiratory flow (FEF) between 25% to 75% of vital capacity (FEF25%-75%), post-bronchodilator FEV1. | Baseline up to 3 years |
| Physician Assessment: Fractional exhaled Nitric Oxide (FeNO) | Assessment collected as per standard of care. | Baseline up to 3 Years |
| Patient Reported Outcome: Asthma Control Questionnaire, 6-item (ACQ-6) | Questionnaire assessing the most common asthma symptoms during the previous week, using a 7-point Likert scale (0=fully controlled; 6=severely uncontrolled). Higher score indicates worse asthma control. | Baseline up to 3 Years |
| Patient Reported Outcome: Mini Asthma Quality of Life Questionnaire (MiniAQLQ) | Questionnaire answered using a 7-point Likert scale (1=maximum impairment; 7=no impairment). Higher score indicates less impact of asthma on quality of life. | Baseline up to 3 Years |
| Patient Reported Outcome: Global Patient Assessment | Assessing patient's symptom severity over the past week and the patient's overall satisfaction with their asthma treatment. Higher scores indicate higher severity of asthma symptoms and lower satisfaction with asthma treatment. | Baseline up to 3 Years |
| Patient Reported Outcome: Physical Activity Limitation Questionnaire (PALQ) | Assessing patient's physical activity in their free time. Higher score indicates more health-related quality of life impairment. | Baseline up to 3 Years |
| Patient Reported Outcome in patients with allergic rhinitis: Allergic Rhinitis Visual Analog Scale (AR-VAS) | Assessing severity of rhinits symptoms where higher score indicates more bothersome allergic symptoms. | Baseline up to 3 Years |
| Patient Reported Outcome in patients with allergic rhinitis: Standardized Rhinoconjunctivitis Quality of Life Questionnaire for patients 12 years of age and older (RQLQ[S]+12) | Health-related quality of life signs and symptoms that are most problematic, as a result of perennial or seasonal allergic rhinitis. RQLQ(S)+12 responses are based on 7-point Likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled). Higher score indicates more health-related quality of life impairment. | Baseline up to 3 Years |
| Patient Reported Outcome in patients with chronic (rhino) sinusitis and/or nasal polyps: Sino-Nasal Outcome Test (SNOT-22) | Questionnaire to assess the impact of chronic rhinosinusitis on quality of life. Lower score represents better health related quality of life. | Baseline up to 3 Years |
| Patient Reported Outcome in patients with atopic dermatitis: Patient Oriented Eczema Measure (POEM) | Questionnaire assessing eczema severity with lower score representing impact of lower severity of less severe eczema. | Baseline up to 3 Years |
| Patient Reported Outcome: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-asthma) | Questionnaire to measure impairments in work and activities with higher score indicating greater impairment and less productivity. | Baseline up to 3 Years |
| Healthcare Utilization: Healthcare Resource Utilization Questionnaire (HCRUQ) | The HCRUQ collects information on unscheduled healthcare resource encounters related to asthma | Baseline up to 3 years |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| Medical Research of Arizona, a Division of Allergy, Asthma & Immunology Associates, Ltd. | Scottsdale | Arizona | 85251 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| Riviera Allergy Medical Center | Redondo Beach | California | 90277 | United States |
| Allergy & Asthma Medical Group and Research, A PC | San Diego | California | 92123 | United States |
| Bensch Clinical Research, LLC | Stockton | California | 95207 | United States |
| Allianz Research Institute, Inc. | Westminster | California | 92683 | United States |
| Global Research Solutions | Hollywood | Florida | 33021 | United States |
| Memorial Healthcare System | Hollywood | Florida | 33021 | United States |
| Clinical Research Specialists, LLC | Kissimmee | Florida | 34746 | United States |
| Kratz Allergy & Asthma | Port Richey | Florida | 34653 | United States |
| GCP, Global Clinical Professionals | St. Petersburg | Florida | 33702 | United States |
| Allergy & Asthma Diagnostic Treatment Center | Tallahassee | Florida | 32308 | United States |
| Omni Allergy | Atlanta | Georgia | 30342 | United States |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | United States |
| IACT Health Southeast Lung Associates | Rincon | Georgia | 31326 | United States |
| Treasure Valley Medical Research | Boise | Idaho | 83706 | United States |
| Northwestern Medical Group Allergy & Immunology Clinic | Chicago | Illinois | 60611 | United States |
| The University of Chicago | Chicago | Illinois | 60634 | United States |
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
| Asthma and Allergy Center of Chicago | Oak Park | Illinois | 60301 | United States |
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | 46202 | United States |
| Velocity Clinical Research | Overland Park | Kansas | 66210 | United States |
| Dr. Henry J. Kanarek Allergy, Asthma & Immunology | Overland Park | Kansas | 66211 | United States |
| Family Allergy and Asthma | Louisville | Kentucky | 40291 | United States |
| Allergy & Asthma Specialists, PSC | Owensboro | Kentucky | 42301 | United States |
| Schreiber Allergy | Rockville | Maryland | 20850 | United States |
| Virgo-Carter Pediatrics | Silver Spring | Maryland | 20910 | United States |
| Chesapeake Clinical Research, Inc. | White Marsh | Maryland | 21162 | United States |
| University of Michigan Allergy Specialty Clinic and Food Allergy Clinic | Ann Arbor | Michigan | 48106 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Allergy and Asthma Center of Minnesota | Maplewood | Minnesota | 55109 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| ENT & Allergy Center of Missouri | Columbia | Missouri | 65201 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| The Clinical Research Center, LLC | St Louis | Missouri | 63141 | United States |
| Nebraska Medical Research Institute, Inc. | Bellevue | Nebraska | 68123 | United States |
| CHI Health Clinic Pulmonary | Omaha | Nebraska | 68124 | United States |
| Ocean Allergy & Respiratory Research Center | Brick | New Jersey | 08724 | United States |
| Atlantic Research Center, LLC | Ocean City | New Jersey | 07712 | United States |
| A Atat Progressive Pulmonary & Sleep Medicine | Brooklyn | New York | 11209 | United States |
| New York Allergy and Sinus Centers | Glendale | New York | 11385 | United States |
| Northwell Health Division of Allergy & Immunology | Great Neck | New York | 11021 | United States |
| Northwell Health Physician Partners Pulmonary Medicine and Cardiology at Manhasset | Manhasset | New York | 11030 | United States |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | United States |
| Summit Health | Oakland Gardens | New York | 11364 | United States |
| RRH Allergy, Immunology & Rheumatology | Rochester | New York | 14607 | United States |
| Allergy & Asthma Care of LI | Rockville Centre | New York | 11570 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Allergy Partners of Western North Carolina | Asheville | North Carolina | 28801 | United States |
| Allergy Partners of the Triangle | Cary | North Carolina | 27518 | United States |
| UNC Children's Hospital | Chapel Hill | North Carolina | 27599 | United States |
| Javara Inc. and Tryon Medical Partners, PLLC | Charlotte | North Carolina | 28210 | United States |
| Airways Clinical Research Center | Winston-Salem | North Carolina | 27104 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45220 | United States |
| Allergy, Asthma and Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Oklahoma Institute of Allergy and Asthma Clinical Research, LLC | Oklahoma City | Oklahoma | 73131 | United States |
| Portland Research | Happy Valley | Oregon | 97086 | United States |
| Allergy and Asthma Specialists, P.C. | Blue Bell | Pennsylvania | 19422 | United States |
| Columbo Asthma, Allergy and Immunology, LLC | Bryn Mawr | Pennsylvania | 19010 | United States |
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15212 | United States |
| Asthma, Nasal Disease & Allergy Research Center of New England | East Providence | Rhode Island | 02914 | United States |
| National Allergy and Asthma Research, LLC | North Charleston | South Carolina | 29420 | United States |
| Charleston ENT Associates, LLC | Summerville | South Carolina | 29486 | United States |
| Precision Research Institute, LLC | Houston | Texas | 77029 | United States |
| STAAMP Research, LLC | San Antonio | Texas | 78229 | United States |
| Element Research Group | San Antonio | Texas | 78258 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |
| Allergy Associates of Utah | Murray | Utah | 84107 | United States |
| Seattle Allergy & Asthma Research Institute | Seattle | Washington | 98115 | United States |
| Gundersen Health System | La Crosse | Wisconsin | 54601 | United States |
| The University of British Columbia | Vancouver | British Columbia | V5Z 1M9 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| BLC Clinical Research | Burlington | Ontario | L7N 3V2 | Canada |
| Evidence Based Medical Educator Inc. | Toronto | Ontario | M5G 1E2 | Canada |
| Inspiration Research Limited | Toronto | Ontario | M5T 3A9 | Canada |
| Dr. Syeed Anees Medicine Professional Corporation | Windsor | Ontario | N8X 1T3 | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) - Universite Laval | Québec | G1V 4G5 | Canada |
| Sygehus Lillebaelt - Vejle Sygehus - Lungemedicinsk afdeling | Vejle | 7100 | Denmark |
| Centre Hospitalier du Pays d'Aix - Maladies Respiratoires | Aix-en-Provence | 13100 | France |
| CHU de Bordeaux | Bordeaux | 33076 | France |
| Centre Hospitalier Universitaire Dijon Bourgogne (CHU Dijon) - Hôpital Francois Mitterrand | Dijon | 21079 | France |
| Hôpital de la Croix-Rousse | Lyon | 69317 | France |
| Hôpital Nord | Marseille | 13015 | France |
| Hopital Jacques Monod | Montivilliers | 76290 | France |
| Fondazione Salvatore Maugeri | Bari | Apulia | 70020 | Italy |
| Ospedale dei Bambini Vittore Buzzi ASST Fatebenefratelli Sacco | Milan | Lombardy | 20154 | Italy |
| Ospedale Luigi Sacco, PU, ASST Fatebenefratelli Sacco | Milan | Lombardy | 20157 | Italy |
| La Fondazione IRCCS Policlinico "San Matteo" | Pavia | Lombardy | 27100 | Italy |
| Istituto Clinico Himanitas, Humanitas Mirasole S.p.a. | Rozzano | Lombardy | 20089 | Italy |
| Azienda Sanitaria Locale Salerno | Battipaglia | Salerno | 84091 | Italy |
| Istituto Nazionale di Riposo e Cura per Anziani | Ancona | The Marches | 60127 | Italy |
| Hansaki Clinic | Kiyosu-shi | Aichi-ken | 452-0001 | Japan |
| Hokkaido University Hospital | Kita-ku | Hokkaido | 060-8648 | Japan |
| Kobe University Hospital | Kobe | Hyōgo | 650-0017 | Japan |
| Dokkyo Medical University Hospital | Mibu | Tochigi | 321-0293 | Japan |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | 113-0033 | Japan |
| Incorporated Medical Corporation, Shishin Iryokai, Respiratory Care Clinic Tokyo | Chuo-ku | Tokyo | 104-0031 | Japan |
| Teikyo University Hospital | Itabashi-ku | Tokyo | 173-8606 | Japan |
| Nihon University Itabashi Hospital | Itabashi-ku | Tokyo | 173-8610 | Japan |
| Incorporated Medical Corporation, Jinyukai, Jinyu Clinic | Nakano Ku | Tokyo | 164-0012 | Japan |
| Showa University Hospital | Shinagawa-ku | Tokyo | 142-8666 | Japan |
| Tokyo Women's Medical University Hospital | Shinjuku-ku | Tokyo | 162-8666 | Japan |
| The Fraternity Memorial Hospital | Sumida-ku | Tokyo | 130-8587 | Japan |
| Agosto Allergy and Immunology | Cayey | 00736 | Puerto Rico |
| CardioPulmonary Research CSP | Guaynabo | 00968 | Puerto Rico |
| Instituto Pulmonary Diseases Torre Medica San Lucas | Ponce | 00731 | Puerto Rico |
| Rafael H Zaragoza - Urdaz | San Juan | 00918 | Puerto Rico |
| Fundacion de Investigacion de Diego | San Juan | 00927 | Puerto Rico |
| University of Puerto Rico Medical Sciences Campus | San Juan | 00936 | Puerto Rico |
| Hospital De La Santa Creu I Sant Pau | Barcelona | Catalonia | 08025 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Catalonia | 08035 | Spain |
| Hospital Germans Trias i Pujol | Barcelona | Catalonia | 08916 | Spain |
| Complexo Hospialario Universitario A Coruña | A Coruña | Galicia | 15006 | Spain |
| Fysikalisk Medicin | Lidingö | Stockholms Län [se-01] | SE-181 58 | Sweden |
| Pennine Acute Hospitals NHS Trust | Manchester | Greater Manchester | M8 5RB | United Kingdom |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | B9 5SS | United Kingdom |
| Royal Devon University Healthcare NHS Foundation Trust | Exeter | EX2 5DW | United Kingdom |
| Gartnavel General Hospital | Glasgow | G12 0YN | United Kingdom |
| St. James Hospital Leeds | Leeds | LS9 7TF | United Kingdom |
| Glenfield General Hospital | Leicester | LE3 9QP | United Kingdom |
| St. Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| Wythenshawe Hospital | Manchester | M23 9QZ | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG5 1PD | United Kingdom |
| Gall R, Jain N, Soong W, Settipane RA, Xia C, Zhang Y, Haselkorn T, Jacob-Nara JA, Siddiqui S. Dupilumab-Treated Patients with Asthma in the Real World: The RAPID Global Registry. Adv Ther. 2023 Mar;40(3):1292-1298. doi: 10.1007/s12325-022-02399-5. Epub 2023 Jan 10. |
| 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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