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

Study Overview
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Brief Summary
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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

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

Conditions
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Chronic Rhinosinusitis With Nasal Polyposis

Intervention / Treatment
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* Drug: DUPIXENT®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DUPIXENT®|No investigational agents will be provided. All treatments will be prescribed at the discretion of the study physician and other healthcare providers.|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRSwNP