Clinical trial NCT04959448: Study Assessing Long-teRm Outcomes of dupiluMAb (DUPIXENT®) Treatment in Adult Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
Official title: Assessing Long-Term Outcomes of DUPIXENT® Treatment in Patients With Chronic Rhinosinusitis With Nasal Polyposis (AROMA)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Rhinosinusitis With Nasal Polyposis
Keywords: CRSwNP
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2021-07-13
Enrollment: 717
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are initiating treatment with DUPIXENT® for CRSwNP according to the country-specific prescribing information.

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Baseline Patient Characteristics
timeFrame: Baseline up to 3 years
measure: Baseline Disease Characteristics
timeFrame: Baseline up to 3 years
Secondary outcomes:
measure: DUPIXENT® Treatment Characteristics
timeFrame: Baseline up to 3 years
measure: CRSwNP Treatment Characteristics
timeFrame: Baseline up to 3 years
measure: Incidence and severity of adverse events (AEs)
timeFrame: Baseline up to 3 years
measure: Participant Assessment: Total symptom score (TSS), including sub-scores (nasal congestion [NC] and loss of smell [LOS])
timeFrame: Baseline up to 3 years
measure: Physician Assessment: Change in University of Pennsylvania Smell Identification Test (UPSIT) score
timeFrame: Baseline up to 3 years
measure: Physician Assessment: CT-Lund-Mackay Score
timeFrame: Baseline up to 3 years
measure: Physician Assessment: Nasal Peak Inspiratory Flow (PNIF)
timeFrame: Baseline up to 3 years
measure: Physician Assessment: - Forced Expiratory Volume in 1 second (FEV1)
timeFrame: Baseline up to 3 years
measure: Physician Assessment: Fractional exhaled Nitric Oxide (FeNO)
timeFrame: Baseline up to 3 Years
measure: Participant Assessment: Asthma Control Questionnaire, 6-item (ACQ-6)
timeFrame: Baseline up to 3 Years
measure: Participant Assessment: Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
timeFrame: Baseline up to 3 Years
measure: Participant Assessment: Allergic Rhinitis (AR) using AR Visual Analog Scale (VAS)
timeFrame: Baseline up to 3 Years
measure: Participant Assessment: Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)
timeFrame: Baseline up to 3 Years
measure: Participant Assessment: Sino-Nasal Outcome Test (SNOT-22)
timeFrame: Baseline up to 3 Years
measure: Participant Assessment: Patient Oriented Eczema Measure (POEM)
timeFrame: Baseline up to 3 Years
measure: Participant Assessment: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-CRSwNP)
timeFrame: Baseline up to 3 Years
measure: Physician Assessment: Changes of Healthcare Utilization
timeFrame: Baseline up to 3 years
measure: Participant Assessment: Short Form 12
timeFrame: Baseline up to 3 years
measure: Participant Assessment: European Quality of Life 5-Dimensions, 5-Level Questionnaire (EQ-5D-5L)
timeFrame: Baseline up to 3 years
measure: Participant Assessment: Global Impression for Symptom Severity, Treatment Satisfaction (Global Patient Assessment)
timeFrame: Baseline up to 3 years
measure: Physician Assessment: Global Impression for Disease Severity (Global Physician Assessment)
timeFrame: Baseline up to 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Excel ENT of Alabama
state: Alabama
city: Scottsdale
country: United States
facility: Medical Research of Arizona, a division of Allergy, Asthma & Immunology Associates
state: Arizona
city: La Jolla
country: United States
facility: The Allergy and Rheumatology Medical Clinic
state: California
city: Long Beach
country: United States
facility: ARK Clinical Research
state: California
city: San Diego
country: United States
facility: Scripps Health - Scripps Clinic Carmel Valley
state: California
city: Torrance
country: United States
facility: Breathe Clear Institute
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Clinical Research
state: California
city: Coral Gables
country: United States
facility: AADRS Clincial Research Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Lake Mary
country: United States
facility: Damask Physicians Group
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Columbus
country: United States
facility: IACT Health
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center UCMC Duchossois Center for Advanced Medicine DCAM
state: Illinois
city: Oak Park
country: United States
facility: Asthma & Allergy Center of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Baltimore
country: United States
facility: John Hopkins University School Of Medicine
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan, Michigan Medicine Pulmonary Clinic
state: Michigan
city: Maplewood
country: United States
facility: Allergy & Asthma Center of Minnesota - Allergology
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Ocean City
country: United States
facility: Atlantic Research Center LLC
state: New Jersey
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester Regional Health System
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Allergy Partners of the Triangle
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Tulsa
country: United States
facility: Essential Medical Research
state: Oklahoma
city: East Providence
country: United States
facility: Asthma, Nasal Disease & Allergy Research Center of New England
state: Rhode Island
city: Lincoln
country: United States
facility: Allergy and Asthma Physicians of RI
state: Rhode Island
city: Charleston
country: United States
facility: Medical University Of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: ADAC research, PA
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Ear, Nose & Throat Clinical
state: South Carolina
city: Summerville
country: United States
facility: ENT & Allergy Partners
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: STAAMP Research
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System (UVA)
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Richmond
country: United States
facility: Richmond Ear Nose & Throat
state: Virginia
city: Vancouver
country: United States
facility: The Vancouver Clinic
state: Washington
city: Vancouver
country: Canada
facility: ENT Clinic Sinus Center, St. Paul's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Dr. Richard Gall Med Corp
state: Manitoba
city: Toronto
country: Canada
facility: Toronto Allergy & Asthma Clinic-Pulmonology
state: Ontario
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
city: Quebec
country: Canada
facility: Hopital Du Saint-Sacrement
city: Mannheim
country: Germany
facility: University Hospital Mannheim - Dermatology, Venerology, Allergology
state: Baden-Württemberg
city: Berlin
country: Germany
facility: Charité
state: Brandenburg
city: Hennigsdorf
country: Germany
facility: Oberhavelkliniken Hennigsdorf
state: Brandenburg
city: Wiesbaden
country: Germany
facility: Zentrum für Rhinologie
state: Hessen
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: University Hospital Münster
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Praxis Dr. Yury Yarin
state: Sachsen
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thüringen
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitara Policlinico di Catania
state: Sicily
city: Pisa
country: Italy
facility: Universita Degli Studi di Pisa Ospedale di Cisanello Pisa
state: Toscana
city: Siena
country: Italy
facility: Azienda Ospedaliero Universitaria Senese
state: Toscana
city: Padova
country: Italy
facility: AOU di Padova
state: Veneto
city: Catanzaro
country: Italy
facility: Università Degli Studi Magna Graecia di Catanzaro
city: Genova
country: Italy
facility: ENT Clinic San Martino Hospital
city: Rome
country: Italy
facility: Azienda Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"
city: Rome
country: Italy
facility: Fondazione universitaria Policlinico A. Gemelli
city: Sassari
country: Italy
facility: Azienda Ospedaliero Universitaria di Sassari
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital - Otorhinolaryngology
state: Hukui
city: Fujisawa
country: Japan
facility: Fujisawa City Hospital
state: Kanagawa
city: Nagaoka
country: Japan
facility: Nagaoka Red Cross Hospital - Otorhinolaryngology
state: Niigita
city: Habikino
country: Japan
facility: Osaka Haibikino Medical Center
state: Osaka
city: Meguro-Ku
country: Japan
facility: Tokyo Kyosai Hospital
state: Tokyo
city: Shinagawa-Ku
country: Japan
facility: Matsuwaki Clinic Shinagawa
state: Tokyo
city: Kyoto
country: Japan
facility: Kyoto Nose & Allergy Clinic
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
state: Noord- Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC location AMC
state: Noord-Holland
city: Leiderdorp
country: Netherlands
facility: Alrijne Ziekenhuis
state: Zuid-Holland
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: