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| ID | Type | Description | Link |
|---|---|---|---|
| 42822 | Registry Identifier | EU HMA-EMA Catalogue |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The primary objectives of the study are:
The secondary objectives of the study are:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DUPIXENT® | Drug | No investigational agents will be provided. All treatments will be prescribed at the discretion of the study physician and other healthcare providers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Patient Characteristics | Demographics includes but is not limited to gender, age, ethnicity, height, weight, BMI, education, current employment status, physician information. | Baseline up to 3 years |
| Baseline Disease Characteristics | Medical History includes but is not limited to history of CRSwNP, comorbid conditions, age at CRSwNP diagnosis, and baseline measurements of effectiveness variables. | Baseline up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| DUPIXENT® Treatment Characteristics | Including but not limited to: usage, dosage, adherence, interruption, place (home or clinic) and frequency of administration | Baseline up to 3 years |
| CRSwNP Treatment Characteristics |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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Patients who are initiating treatment with DUPIXENT® for CRSwNP 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 |
|---|---|---|---|---|---|---|
| Excel ENT of Alabama | Birmingham | Alabama | 35244 | United States | ||
| Medical Research of Arizona, a division of Allergy, Asthma & Immunology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40958188 | Derived | Peters AT, Shah R, Heffler E, Wagenmann M, Fujieda S, Xia C, Nash S, Clotz M, Corbett M, Radwan A. Baseline disease characteristics among patients with chronic rhinosinusitis with nasal polyps in AROMA: A global registry study. Allergy Asthma Proc. 2025 Sep 1;46(5):414-421. doi: 10.2500/aap.2025.46.250055. | |
| 36451848 | Derived |
| Label | URL |
|---|---|
| THE AROMA LANDMARK REGISTRY: A GLOBAL STUDY INVOLVING AN APPROVED INJECTABLE MEDICINE FOR CHRONIC RHINOSINUSITIS WITH NASAL POLYPS | View source |
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All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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Including but not limited to: usage, dosage, adherence, duration and frequency
| Baseline up to 3 years |
| Incidence and severity of adverse events (AEs) | Baseline up to 3 years |
| Participant Assessment: Total symptom score (TSS), including sub-scores (nasal congestion [NC] and loss of smell [LOS]) | The TSS is a composite score (ranging between 0 and 9) and consisting of the sum of the following symptoms assessed daily: nasal congestion/obstruction, decreased/loss of sense of smell, rhinorrhea (average of anterior/posterior nasal discharge). Higher scores indicate greater symptom burden. | Baseline up to 3 years |
| Physician Assessment: Change in University of Pennsylvania Smell Identification Test (UPSIT) score | The UPSIT (UPSIT 40-odorant test) is a rapid and easy-to-administer method to quantitatively assess human olfactory function. | Baseline up to 3 years |
| Physician Assessment: CT-Lund-Mackay Score | The LMK system is scoring based on CT imaging of the sinuses with points given for degree of opacification: 0 = no opacification, 1 = partial opacification, 2 = total opacification. These points are then applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side. The ostiomeatal complex is graded as 0 = not occluded, or 2 = occluded. The sum of these derives a maximum score of 12 per side and 24 in total. | Baseline up to 3 years |
| Physician Assessment: Nasal Peak Inspiratory Flow (PNIF) | Nasal peak inspiratory flow (NPIF) is a measure of the air flow through both nasal cavities during forced inspiration expressed in liters per minute. | Baseline up to 3 years |
| Physician Assessment: - Forced Expiratory Volume in 1 second (FEV1) | Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled in the first second of a forced exhalation | Baseline up to 3 years |
| Physician Assessment: Fractional exhaled Nitric Oxide (FeNO) | FeNO (Fractional exhaled Nitric Oxiide) is analyzed using a respiratory flow rate of 50 mL/second and reported in ppb. | Baseline up to 3 Years |
| Participant Assessment: Asthma Control Questionnaire, 6-item (ACQ-6) | The ACQ-6 assesses asthma control with scores ranging from 0 (fully controlled; 6=severely uncontrolled). | Baseline up to 3 Years |
| Participant Assessment: Mini Asthma Quality of Life Questionnaire (MiniAQLQ) | The MiniAQLQ is assesses the impact of asthma on health-related quality of life with scores ranging from 1 (maximum impairment) to 7 (no impairment). | Baseline up to 3 Years |
| Participant Assessment: Allergic Rhinitis (AR) using AR Visual Analog Scale (VAS) | The AR-VAS assesses severity of rhinosinusitis symptoms on a 0 (not troublesome) to 10 (worst thinkable troublesome) scale. | Baseline up to 3 Years |
| Participant Assessment: Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) | The MiniRQLQ is an abbreviated version of the RQLQ(S)+12 which assesses health-related quality of life associated with perennial or seasonal allergic rhinitis with scores ranging from 0 (not troubled) to 6 (extremely troubled). | Baseline up to 3 Years |
| Participant Assessment: Sino-Nasal Outcome Test (SNOT-22) | The SNOT-22 assesses the impact of chronic rhinosinusitis on health-related quality of life with scores ranging from 0 to 110; lower scores representing better health related quality of life. | Baseline up to 3 Years |
| Participant Assessment: Patient Oriented Eczema Measure (POEM) | The POEM assesses symptoms of dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping with scores ranging from 0 to 28; higher scores indicate greater symptom burden. | Baseline up to 3 Years |
| Participant Assessment: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-CRSwNP) | The WPAI-CRSwNP measures impairments in work and activities associated with CRSwNP. Scores are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Baseline up to 3 Years |
| Physician Assessment: Changes of Healthcare Utilization | Resource use collected from medical, hospital, and pharmacy records | Baseline up to 3 years |
| Participant Assessment: Short Form 12 | The SF-12 assesses physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy/vitality, pain, and general health perception with scores ranging from 0 to 100; lower scores represent greater quality of life impairment. | Baseline up to 3 years |
| Participant Assessment: European Quality of Life 5-Dimensions, 5-Level Questionnaire (EQ-5D-5L) | The EQ 5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and the EQ-VAS records the respondent's self rated health on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state). | Baseline up to 3 years |
| Participant Assessment: Global Impression for Symptom Severity, Treatment Satisfaction (Global Patient Assessment) | The Global Patient Assessment is a 2-component questionnaire on symptom severity over the past week and the patient's overall satisfaction with their CRSwNP treatment. | Baseline up to 3 years |
| Physician Assessment: Global Impression for Disease Severity (Global Physician Assessment) | The Global Physician Assessment is a 1-item question asking physicians to rate the severity of their patient's CRSwNP. | Baseline up to 3 years |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| The Allergy and Rheumatology Medical Clinic | La Jolla | California | 92037 | United States |
| ARK Clinical Research | Long Beach | California | 90806 | United States |
| Scripps Health - Scripps Clinic Carmel Valley | San Diego | California | 92130 | United States |
| Breathe Clear Institute | Torrance | California | 90503 | United States |
| Allergy & Asthma Clinical Research | Walnut Creek | California | 94598 | United States |
| AADRS Clincial Research Center | Coral Gables | Florida | 33134 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Damask Physicians Group | Lake Mary | Florida | 32746 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| IACT Health | Columbus | Georgia | 31904 | United States |
| Treasure Valley Medical Research | Boise | Idaho | 83706 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| University of Illinois | Chicago | Illinois | 60612 | United States |
| The University of Chicago Medical Center UCMC Duchossois Center for Advanced Medicine DCAM | Chicago | Illinois | 60637 | United States |
| Asthma & Allergy Center of Chicago | Oak Park | Illinois | 60301 | United States |
| Indiana University Health | Indianapolis | Indiana | 46202 | United States |
| John Hopkins University School Of Medicine | Baltimore | Maryland | 21224 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan, Michigan Medicine Pulmonary Clinic | Ann Arbor | Michigan | 48109-5000 | United States |
| Allergy & Asthma Center of Minnesota - Allergology | Maplewood | Minnesota | 55109 | United States |
| University of Missouri | Columbia | Missouri | 65212 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Atlantic Research Center LLC | Ocean City | New Jersey | 07712 | United States |
| Northwell Health | Great Neck | New York | 11021 | United States |
| Montefiore Medical Center | New York | New York | 10461 | United States |
| Rochester Regional Health System | Rochester | New York | 14626 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Allergy Partners of the Triangle | Raleigh | North Carolina | 27607 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| University of Cincinnati College of Medicine | Cincinnati | Ohio | 45229 | United States |
| Essential Medical Research | Tulsa | Oklahoma | 74137 | United States |
| Asthma, Nasal Disease & Allergy Research Center of New England | East Providence | Rhode Island | 02914 | United States |
| Allergy and Asthma Physicians of RI | Lincoln | Rhode Island | 02865 | United States |
| Medical University Of South Carolina | Charleston | South Carolina | 29425 | United States |
| ADAC research, PA | Greenville | South Carolina | 29607 | United States |
| Spartanburg Ear, Nose & Throat Clinical | Spartanburg | South Carolina | 29303 | United States |
| ENT & Allergy Partners | Summerville | South Carolina | 29486 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| STAAMP Research | San Antonio | Texas | 78229 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |
| University of Virginia Health System (UVA) | Charlottesville | Virginia | 22903 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23510 | United States |
| Richmond Ear Nose & Throat | Richmond | Virginia | 23235 | United States |
| The Vancouver Clinic | Vancouver | Washington | 98664 | United States |
| ENT Clinic Sinus Center, St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Dr. Richard Gall Med Corp | Winnipeg | Manitoba | R3P1C7 | Canada |
| Toronto Allergy & Asthma Clinic-Pulmonology | Toronto | Ontario | M5G 1E2 | Canada |
| Centre hospitalier de l'Université de Montréal | Montreal | Quebec | H2X 3E4 | Canada |
| Hopital Du Saint-Sacrement | Québec | G1S 4L8 | Canada |
| University Hospital Mannheim - Dermatology, Venerology, Allergology | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Charité | Berlin | Brandenburg | 10117 | Germany |
| Oberhavelkliniken Hennigsdorf | Hennigsdorf | Brandenburg | 16761 | Germany |
| Zentrum für Rhinologie | Wiesbaden | Hesse | 65183 | Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| University Hospital Münster | Münster | North Rhine-Westphalia | 48149 | Germany |
| Praxis Dr. Yury Yarin | Dresden | Saxony | 01139 | Germany |
| Universitätsklinikum Jena | Jena | Thuringia | 07740 | Germany |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| Azienda Ospedaliero Universitara Policlinico di Catania | Catania | Sicily | 95125 | Italy |
| Universita Degli Studi di Pisa Ospedale di Cisanello Pisa | Pisa | Tuscany | 56100 | Italy |
| Azienda Ospedaliero Universitaria Senese | Siena | Tuscany | 53100 | Italy |
| AOU di Padova | Padova | Veneto | 35128 | Italy |
| Università Degli Studi Magna Graecia di Catanzaro | Catanzaro | 88100 | Italy |
| ENT Clinic San Martino Hospital | Genova | 16126 | Italy |
| Azienda Policlinico Umberto I - Università degli Studi di Roma "La Sapienza" | Rome | 00161 | Italy |
| Fondazione universitaria Policlinico A. Gemelli | Rome | 00168 | Italy |
| Azienda Ospedaliero Universitaria di Sassari | Sassari | 07100 | Italy |
| University of Fukui Hospital - Otorhinolaryngology | Yoshida-gun | Hukui | 910-1193 | Japan |
| Fujisawa City Hospital | Fujisawa | Kanagawa | 251-8550 | Japan |
| Nagaoka Red Cross Hospital - Otorhinolaryngology | Nagaoka | Niigita | 940-2085 | Japan |
| Osaka Haibikino Medical Center | Habikino | Osaka | 583-8588 | Japan |
| Tokyo Kyosai Hospital | Meguro-Ku | Tokyo | 153-8934 | Japan |
| Matsuwaki Clinic Shinagawa | Shinagawa-Ku | Tokyo | 141-0001 | Japan |
| Kyoto Nose & Allergy Clinic | Kyoto | 600-8216 | Japan |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | North Holland | 1091 AC | Netherlands |
| Amsterdam UMC location AMC | Amsterdam | North Holland | 1105 | Netherlands |
| Alrijne Ziekenhuis | Leiderdorp | South Holland | 2353 | Netherlands |
| Siddiqui S, Bachert C, Chaker AM, Han JK, Hellings PW, Peters AT, Heffler E, Kamat S, Zhang H, Nash S, Khan AH, De Prado Gomez L, Jacob-Nara JA, Rowe PJ, Deniz Y. AROMA: real-world global registry of dupilumab for chronic rhinosinusitis with nasal polyps. ERJ Open Res. 2022 Nov 28;8(4):00085-2022. doi: 10.1183/23120541.00085-2022. eCollection 2022 Oct. |
| ID | Term |
|---|---|
| C582203 | dupilumab |
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