Study Assessing Long-teRm Outcomes of dupiluMAb (DUPIXENT®) Treatment in Adult Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
- Conditions
- Chronic Rhinosinusitis With Nasal Polyposis
- Registration Number
- NCT04959448
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 717
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Baseline Patient Characteristics Baseline up to 3 years Demographics includes but is not limited to gender, age, ethnicity, height, weight, BMI, education, current employment status, physician information.
Baseline Disease Characteristics Baseline up to 3 years Medical History includes but is not limited to history of CRSwNP, comorbid conditions, age at CRSwNP diagnosis, and baseline measurements of effectiveness variables.
- Secondary Outcome Measures
Name Time Method DUPIXENT® Treatment Characteristics Baseline up to 3 years Including but not limited to: usage, dosage, adherence, interruption, place (home or clinic) and frequency of administration
CRSwNP Treatment Characteristics Baseline up to 3 years Including but not limited to: usage, dosage, adherence, duration and frequency
Incidence and severity of adverse events (AEs) Baseline up to 3 years Participant Assessment: Sino-Nasal Outcome Test (SNOT-22) Baseline up to 3 Years 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.
Participant Assessment: Patient Oriented Eczema Measure (POEM) Baseline up to 3 Years 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.
Participant Assessment: Total symptom score (TSS), including sub-scores (nasal congestion [NC] and loss of smell [LOS]) Baseline up to 3 years 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.
Physician Assessment: Change in University of Pennsylvania Smell Identification Test (UPSIT) score Baseline up to 3 years The UPSIT (UPSIT 40-odorant test) is a rapid and easy-to-administer method to quantitatively assess human olfactory function.
Physician Assessment: CT-Lund-Mackay Score Baseline up to 3 years 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.Physician Assessment: Nasal Peak Inspiratory Flow (PNIF) Baseline up to 3 years Nasal peak inspiratory flow (NPIF) is a measure of the air flow through both nasal cavities during forced inspiration expressed in liters per minute.
Physician Assessment: - Forced Expiratory Volume in 1 second (FEV1) Baseline up to 3 years 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
Physician Assessment: Fractional exhaled Nitric Oxide (FeNO) Baseline up to 3 Years FeNO (Fractional exhaled Nitric Oxiide) is analyzed using a respiratory flow rate of 50 mL/second and reported in ppb.
Participant Assessment: Asthma Control Questionnaire, 6-item (ACQ-6) Baseline up to 3 Years The ACQ-6 assesses asthma control with scores ranging from 0 (fully controlled; 6=severely uncontrolled).
Participant Assessment: Mini Asthma Quality of Life Questionnaire (MiniAQLQ) Baseline up to 3 Years 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).
Participant Assessment: Allergic Rhinitis (AR) using AR Visual Analog Scale (VAS) Baseline up to 3 Years The AR-VAS assesses severity of rhinosinusitis symptoms on a 0 (not troublesome) to 10 (worst thinkable troublesome) scale.
Participant Assessment: Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Baseline up to 3 Years 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).
Participant Assessment: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-CRSwNP) Baseline up to 3 Years 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.
Physician Assessment: Changes of Healthcare Utilization Baseline up to 3 years Resource use collected from medical, hospital, and pharmacy records
Participant Assessment: Short Form 12 Baseline up to 3 years 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.
Participant Assessment: European Quality of Life 5-Dimensions, 5-Level Questionnaire (EQ-5D-5L) Baseline up to 3 years 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).
Participant Assessment: Global Impression for Symptom Severity, Treatment Satisfaction (Global Patient Assessment) Baseline up to 3 years 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.
Physician Assessment: Global Impression for Disease Severity (Global Physician Assessment) Baseline up to 3 years The Global Physician Assessment is a 1-item question asking physicians to rate the severity of their patient's CRSwNP.
Trial Locations
- Locations (81)
John Hopkins University School Of Medicine
🇺🇸Baltimore, Maryland, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
The University of Chicago Medical Center UCMC Duchossois Center for Advanced Medicine DCAM
🇺🇸Chicago, Illinois, United States
Scripps Health - Scripps Clinic Carmel Valley
🇺🇸San Diego, California, United States
Medical Research of Arizona, a division of Allergy, Asthma & Immunology Associates
🇺🇸Scottsdale, Arizona, United States
AOU di Padova
🇮🇹Padova, Veneto, Italy
IACT Health
🇺🇸Columbus, Georgia, United States
AADRS Clincial Research Center
🇺🇸Coral Gables, Florida, United States
The Allergy and Rheumatology Medical Clinic
🇺🇸La Jolla, California, United States
Allergy & Asthma Clinical Research
🇺🇸Walnut Creek, California, United States
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Nordrhein-Westfalen, Germany
Oberhavelkliniken Hennigsdorf
🇩🇪Hennigsdorf, Brandenburg, Germany
Universita Degli Studi di Pisa Ospedale di Cisanello Pisa
🇮🇹Pisa, Toscana, Italy
Praxis Dr. Yury Yarin
🇩🇪Dresden, Sachsen, Germany
Azienda Ospedaliero Universitara Policlinico di Catania
🇮🇹Catania, Sicily, Italy
Zentrum für Rhinologie
🇩🇪Wiesbaden, Hessen, Germany
Alrijne Ziekenhuis
🇳🇱Leiderdorp, Zuid-Holland, Netherlands
Universitätsklinikum Jena
🇩🇪Jena, Thüringen, Germany
Fujisawa City Hospital
🇯🇵Fujisawa, Kanagawa, Japan
Nagaoka Red Cross Hospital - Otorhinolaryngology
🇯🇵Nagaoka, Niigita, Japan
University Hospital Münster
🇩🇪Muenster, Nordrhein-Westfalen, Germany
Azienda Ospedaliero Universitaria Senese
🇮🇹Siena, Toscana, Italy
Tokyo Kyosai Hospital
🇯🇵Meguro-Ku, Tokyo, Japan
Fondazione universitaria Policlinico A. Gemelli
🇮🇹Rome, Italy
Amsterdam UMC location AMC
🇳🇱Amsterdam, Noord-Holland, Netherlands
Kyoto Nose & Allergy Clinic
🇯🇵Kyoto, Japan
Osaka Haibikino Medical Center
🇯🇵Habikino, Osaka, Japan
University Hospital Mannheim - Dermatology, Venerology, Allergology
🇩🇪Mannheim, Baden-Württemberg, Germany
ENT Clinic Sinus Center, St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Charité
🇩🇪Berlin, Brandenburg, Germany
University of Florida
🇺🇸Gainesville, Florida, United States
Matsuwaki Clinic Shinagawa
🇯🇵Shinagawa-Ku, Tokyo, Japan
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
Università Degli Studi Magna Graecia di Catanzaro
🇮🇹Catanzaro, Italy
Dr. Richard Gall Med Corp
🇨🇦Winnipeg, Manitoba, Canada
Centre hospitalier de l'Université de Montréal
🇨🇦Montreal, Quebec, Canada
Hopital Du Saint-Sacrement
🇨🇦Quebec, Canada
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
University of South Florida
🇺🇸Tampa, Florida, United States
ARK Clinical Research
🇺🇸Long Beach, California, United States
Excel ENT of Alabama
🇺🇸Birmingham, Alabama, United States
Breathe Clear Institute
🇺🇸Torrance, California, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Damask Physicians Group
🇺🇸Lake Mary, Florida, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
University of Illinois
🇺🇸Chicago, Illinois, United States
Asthma & Allergy Center of Chicago
🇺🇸Oak Park, Illinois, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Allergy & Asthma Center of Minnesota - Allergology
🇺🇸Maplewood, Minnesota, United States
Indiana University Health
🇺🇸Indianapolis, Indiana, United States
University of Missouri
🇺🇸Columbia, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Atlantic Research Center LLC
🇺🇸Ocean City, New Jersey, United States
Northwell Health
🇺🇸Great Neck, New York, United States
Rochester Regional Health System
🇺🇸Rochester, New York, United States
Allergy Partners of the Triangle
🇺🇸Raleigh, North Carolina, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Allergy and Asthma Physicians of RI
🇺🇸Lincoln, Rhode Island, United States
Essential Medical Research
🇺🇸Tulsa, Oklahoma, United States
Asthma, Nasal Disease & Allergy Research Center of New England
🇺🇸East Providence, Rhode Island, United States
ADAC research, PA
🇺🇸Greenville, South Carolina, United States
Spartanburg Ear, Nose & Throat Clinical
🇺🇸Spartanburg, South Carolina, United States
ENT & Allergy Partners
🇺🇸Summerville, South Carolina, United States
STAAMP Research
🇺🇸San Antonio, Texas, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
University of Virginia Health System (UVA)
🇺🇸Charlottesville, Virginia, United States
The Vancouver Clinic
🇺🇸Vancouver, Washington, United States
Azienda Ospedaliero Universitaria di Sassari
🇮🇹Sassari, Italy
ENT Clinic San Martino Hospital
🇮🇹Genova, Italy
Azienda Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"
🇮🇹Rome, Italy
University of Fukui Hospital - Otorhinolaryngology
🇯🇵Yoshida-gun, Hukui, Japan
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Noord- Holland, Netherlands
University of Cincinnati College of Medicine
🇺🇸Cincinnati, Ohio, United States
Toronto Allergy & Asthma Clinic-Pulmonology
🇨🇦Toronto, Ontario, Canada
University of Michigan, Michigan Medicine Pulmonary Clinic
🇺🇸Ann Arbor, Michigan, United States
Richmond Ear Nose & Throat
🇺🇸Richmond, Virginia, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Medical University Of South Carolina
🇺🇸Charleston, South Carolina, United States
Montefiore Medical Center
🇺🇸New York, New York, United States