Study Assessing Long-teRm Outcomes of dupiluMAb (DUPIXENT®) Treatment in Adult Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) (AROMA)

Assessing Long-Term Outcomes of DUPIXENT® Treatment in Patients With Chronic Rhinosinusitis With Nasal Polyposis (AROMA)

The primary objectives of the study are:

• To longitudinally characterize the long-term effectiveness of DUPIXENT® through assessment of patient-reported symptoms, Health-Related Quality of Life (HRQoL) related to Chronic rhinosinusitis with nasal polyposis (CRSwNP) and other type 2 comorbidities, and their change over-time.
• To characterize patients who receive DUPIXENT® for CRSwNP in a real-world setting with respect to their medical history, demographic and disease characteristics, and type 2 comorbidities

The secondary objectives of the study are:

• To characterize real-world utilization of DUPIXENT® for patients with CRSwNP
• To collect patient and physician global assessment of disease severity and treatment satisfaction for patients receiving DUPIXENT® for CRSwNP
• To collect long-term safety data for patients receiving DUPIXENT® for CRSwNP

Study Overview

• Status: Recruiting
• Conditions: Chronic Rhinosinusitis With Nasal Polyposis
• Intervention / Treatment: Drug: DUPIXENT®

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Study Locations

• Canada
  • Quebec, Canada, G1S 4L8
    • Recruiting
    • Hopital Du Saint-Sacrement
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Recruiting
      • ENT Clinic Sinus Center, St. Paul's Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3P1C7
      • Recruiting
      • Dr. Richard Gall Med Corp
  • Ontario
    • Toronto, Ontario, Canada, M5G 1E2
      • Recruiting
      • Toronto Allergy & Asthma Clinic-Pulmonology
    • Toronto, Ontario, Canada, M3B 3S6
      • Withdrawn
      • Gordon Sussman Clinical Research
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Recruiting
      • Centre Hospitalier de l'Universite de Montreal
• Germany
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68167
      • Recruiting
      • University Hospital Mannheim - Dermatology, Venerology, Allergology
  • Brandenburg
    • Berlin, Brandenburg, Germany, 10117
      • Recruiting
      • Charité
    • Hennigsdorf, Brandenburg, Germany, 16761
      • Recruiting
      • Oberhavelkliniken Hennigsdorf
  • Hessen
    • Wiesbaden, Hessen, Germany, 65183
      • Recruiting
      • Zentrum für Rhinologie
  • Nordrhein-Westfalen
    • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
      • Recruiting
      • Universitätsklinikum Düsseldorf
    • Muenster, Nordrhein-Westfalen, Germany, 48149
      • Recruiting
      • University Hospital Münster
  • Sachsen
    • Dresden, Sachsen, Germany, 01139
      • Recruiting
      • Praxis Dr. Yury Yarin
  • Thüringen
    • Jena, Thüringen, Germany, 07740
      • Recruiting
      • Universitätsklinikum Jena
• Italy
  • Catanzaro, Italy, 88100
    • Recruiting
    • Università Degli Studi Magna Graecia di Catanzaro
  • Genova, Italy, 16126
    • Recruiting
    • ENT Clinic San Martino Hospital
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione universitaria Policlinico A. Gemelli
  • Rome, Italy, 00161
    • Recruiting
    • Azienda Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"
  • Sassari, Italy, 07100
    • Recruiting
    • Azienda Ospedaliero Universitaria di Sassari
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • Istituto Clinico Humanitas
  • Sicily
    • Catania, Sicily, Italy, 95125
      • Recruiting
      • Azienda Ospedaliero Universitara Policlinico di Catania
  • Toscana
    • Pisa, Toscana, Italy, 56100
      • Recruiting
      • Universita Degli Studi di Pisa Ospedale di Cisanello Pisa
    • Siena, Toscana, Italy, 53100
      • Recruiting
      • Azienda Ospedaliero Universitaria Senese
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Recruiting
      • AOU di Padova
• Japan
  • Kyoto, Japan, 600-8216
    • Recruiting
    • Kyoto Nose & Allergy Clinic
  • Hukui
    • Yoshida-gun, Hukui, Japan, 910-1193
      • Recruiting
      • University of Fukui Hospital - Otorhinolaryngology
  • Kanagawa
    • Fujisawa, Kanagawa, Japan, 251-8550
      • Recruiting
      • Fujisawa City Hospital
  • Niigita
    • Nagaoka, Niigita, Japan, 940-2085
      • Recruiting
      • Nagaoka Red Cross Hospital - Otorhinolaryngology
  • Osaka
    • Habikino, Osaka, Japan, 583-8588
      • Recruiting
      • Osaka Haibikino Medical Center
  • Tokyo
    • Meguro-Ku, Tokyo, Japan, 153-8934
      • Recruiting
      • Tokyo Kyosai Hospital
    • Shinagawa-Ku, Tokyo, Japan, 141-0001
      • Recruiting
      • Matsuwaki Clinic Shinagawa
• Netherlands
  • Noord- Holland
    • Amsterdam, Noord- Holland, Netherlands, 1091 AC
      • Recruiting
      • Onze Lieve Vrouwe Gasthuis
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105
      • Recruiting
      • Amsterdam UMC Location AMC
  • Zuid-Holland
    • Leiderdorp, Zuid-Holland, Netherlands, 2353
      • Recruiting
      • Alrijne ziekenhuis
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Recruiting
      • Excel ENT of Alabama
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Recruiting
      • Medical Research of Arizona, a division of Allergy, Asthma & Immunology Associates
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • The Allergy and Rheumatology Medical Clinic
    • Long Beach, California, United States, 90806
      • Recruiting
      • Ark Clinical Research
    • Roseville, California, United States, 95661
      • Withdrawn
      • Sacramento Ear, Nose & Throat
    • San Diego, California, United States, 92130
      • Recruiting
      • Scripps Health - Scripps Clinic Carmel Valley
    • Torrance, California, United States, 90503
      • Recruiting
      • Breathe Clear Institute
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • Allergy & Asthma Clinical Research
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Recruiting
      • AADRS Clincial Research Center
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
    • Lake Mary, Florida, United States, 32746
      • Recruiting
      • Damask Physicians Group
    • Tampa, Florida, United States, 33612
      • Recruiting
      • University of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Recruiting
      • Emory University Hospital Midtown
    • Columbus, Georgia, United States, 31904
      • Recruiting
      • IACT Health
  • Idaho
    • Boise, Idaho, United States, 83706
      • Recruiting
      • Treasure Valley Medical Research
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University Feinberg School of Medicine
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • The University of Chicago Medical Center UCMC Duchossois Center for Advanced Medicine DCAM
    • Oak Park, Illinois, United States, 60301
      • Recruiting
      • Asthma & Allergy Center of Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Health
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • John Hopkins University School of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham & Women's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5000
      • Recruiting
      • University of Michigan, Michigan Medicine Pulmonary Clinic
  • Minnesota
    • Maplewood, Minnesota, United States, 55109
      • Recruiting
      • Allergy & Asthma Center of Minnesota - Allergology
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Recruiting
      • University of Missouri
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
  • New Jersey
    • Ocean City, New Jersey, United States, 07712
      • Recruiting
      • Atlantic Research Center LLC
  • New York
    • Great Neck, New York, United States, 11021
      • Recruiting
      • Northwell Health
    • New York, New York, United States, 10461
      • Recruiting
      • Montefiore Medical Center
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester Medical Center
    • Rochester, New York, United States, 14626
      • Recruiting
      • Rochester Regional Health System
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
    • Raleigh, North Carolina, United States, 27607
      • Recruiting
      • Allergy Partners of the Triangle
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Baptist Health
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • University of Cincinnati College of Medicine
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74137
      • Recruiting
      • Essential Medical Research
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Recruiting
      • Asthma, Nasal Disease & Allergy Research Center of New England
    • Lincoln, Rhode Island, United States, 02865
      • Recruiting
      • Allergy and Asthma Physicians of RI
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Terminated
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 29607
      • Recruiting
      • ADAC research, PA
    • Spartanburg, South Carolina, United States, 29303
      • Recruiting
      • Spartanburg Ear, Nose & Throat Clinical
    • Summerville, South Carolina, United States, 29486
      • Recruiting
      • ENT & Allergy Partners
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • STAAMP Research
  • Utah
    • Layton, Utah, United States, 84041
      • Recruiting
      • Tanner Clinic
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia Health System (UVA)
    • Norfolk, Virginia, United States, 23510
      • Recruiting
      • Eastern Virginia Medical School
    • Richmond, Virginia, United States, 23235
      • Recruiting
      • Richmond Ear Nose & Throat
  • Washington
    • Vancouver, Washington, United States, 98664
      • Recruiting
      • The Vancouver Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are initiating treatment with DUPIXENT® for CRSwNP according to the country-specific prescribing information.

Description

Key Inclusion Criteria:

• All patients who are newly initiated on DUPIXENT® for the treatment of CRSwNP according to the respective prescribing information (Product Label or SmPC)
• Willing and able to comply with clinic visits and study-related procedures as per protocol
• Provide informed consent signed by study patient or legally acceptable representative
• Able to understand and complete study-related questionnaires as per protocol

Key Exclusion Criteria:

• Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information
• Any previous treatment with DUPIXENT® for any condition
• Any condition that, in the opinion of the investigator, may interfere with the patient's ability to participate in the study per protocol
• Participation in an ongoing interventional or observational study that might, in the treating physician's opinion, influence the assessments for the current study per protocol

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2021
• Primary Completion (Estimated): July 25, 2027
• Study Completion (Estimated): July 25, 2027

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: CRSwNP
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Paranasal Sinus Diseases; Nose Diseases; Polyps; Rhinitis; Nasopharyngeal Neoplasms; Colorectal Neoplasms; Sinusitis; Nasal Polyps; Rhinosinusitis
• Other Study ID Numbers: R668-cSNP-2072; EUPAS41656 (Other Identifier: ENCePP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
• IPD Sharing Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• IPD Sharing Access Criteria: 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No