NCT04959448Active, not recruitingNot Applicable
Assessing Long-Term Outcomes of DUPIXENT® Treatment in Patients With Chronic Rhinosinusitis With Nasal Polyposis (AROMA)
Regeneron Pharmaceuticals144 sites in 4 countries717 target enrollmentStarted: August 12, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 717
- Locations
- 144
- Primary Endpoint
- Baseline Patient Characteristics
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Outcomes
Primary Outcomes
Baseline Patient Characteristics
Time Frame: 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
Time Frame: 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 Outcomes
- DUPIXENT® Treatment Characteristics(Baseline up to 3 years)
- CRSwNP Treatment Characteristics(Baseline up to 3 years)
- Incidence and severity of adverse events (AEs)(Baseline up to 3 years)
- Participant Assessment: Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)(Baseline up to 3 Years)
- Participant Assessment: Total symptom score (TSS), including sub-scores (nasal congestion [NC] and loss of smell [LOS])(Baseline up to 3 years)
- Physician Assessment: Change in University of Pennsylvania Smell Identification Test (UPSIT) score(Baseline up to 3 years)
- Physician Assessment: CT-Lund-Mackay Score(Baseline up to 3 years)
- Physician Assessment: Nasal Peak Inspiratory Flow (PNIF)(Baseline up to 3 years)
- Physician Assessment: - Forced Expiratory Volume in 1 second (FEV1)(Baseline up to 3 years)
- Physician Assessment: Fractional exhaled Nitric Oxide (FeNO)(Baseline up to 3 Years)
- Participant Assessment: Asthma Control Questionnaire, 6-item (ACQ-6)(Baseline up to 3 Years)
- Participant Assessment: Mini Asthma Quality of Life Questionnaire (MiniAQLQ)(Baseline up to 3 Years)
- Participant Assessment: Allergic Rhinitis (AR) using AR Visual Analog Scale (VAS)(Baseline up to 3 Years)
- Participant Assessment: Sino-Nasal Outcome Test (SNOT-22)(Baseline up to 3 Years)
- Participant Assessment: Patient Oriented Eczema Measure (POEM)(Baseline up to 3 Years)
- Participant Assessment: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-CRSwNP)(Baseline up to 3 Years)
- Physician Assessment: Changes of Healthcare Utilization(Baseline up to 3 years)
- Participant Assessment: Short Form 12(Baseline up to 3 years)
- Participant Assessment: European Quality of Life 5-Dimensions, 5-Level Questionnaire (EQ-5D-5L)(Baseline up to 3 years)
- Participant Assessment: Global Impression for Symptom Severity, Treatment Satisfaction (Global Patient Assessment)(Baseline up to 3 years)
- Physician Assessment: Global Impression for Disease Severity (Global Physician Assessment)(Baseline up to 3 years)
Investigators
Study Sites (144)
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