Study Assessing long-teRm Outcomes of dupiluMAb (DUPIXENT) treatment in adult patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) (AROMA)

Active, not recruiting

• Conditions: Chronic rhinosinusitis with nasal polyposis (CRSwNP)

• Registration Number: jRCT1031210642
• Lead Sponsor: Regeneron pharmaceutical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-03
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients in or over 18 years at initiation
2. All patients who are newly initiated on DUPIXENT for the treatment of CRSwNP according to the respective prescribing information (Product Label or SmPC)
3. Willing and able to comply with clinic visits and study-related procedures as per protocol
4. Provide informed consent signed by study patient or legally acceptable representative
5. Able to understand and complete study-related questionnaires as per protocol

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-		- Baseline Patient Characteristics; - Baseline Disease Characteristics

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs)		Incidence and severity of adverse events (AEs)
Total symptom score (TSS)		Participant Assessment: Total symptom score (TSS), including sub-scores (nasal congestion [NC] and loss of smell [LOS])
Change in University of Pennsylvania Smell Identification Test (UPSIT) score		Physician Assessment: Change in University of Pennsylvania Smell Identification Test (UPSIT) score
CT-Lund-Mackay Score		Physician Assessment: CT-Lund-Mackay Score
Nasal Peak Inspiratory Flow (PNIF)		Physician Assessment: Nasal Peak Inspiratory Flow (PNIF)
Forced Expiratory Volume in 1 second (FEV1)		Physician Assessment: Forced Expiratory Volume in 1 second (FEV1)
Fractional exhaled Nitric Oxide (FeNO)		Physician Assessment: Fractional exhaled Nitric Oxide (FeNO)
Asthma Control Questionnaire, 6-item (ACQ-6)		Participant Assessment: Asthma Control Questionnaire, 6-item (ACQ-6)
Mini Asthma Quality of Life Questionnaire (MiniAQLQ)		Participant Assessment: Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-CRSwNP)		Participant Assessment: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-CRSwNP)
Short Form 12		Participant Assessment: Short Form 12
European Quality of Life 5-Dimensions, 5-Level Questionnaire (EQ-5D-5L)		Participant Assessment: European Quality of Life 5-Dimensions, 5-Level Questionnaire (EQ-5D-5L)
Global Impression for Disease Severity (Global Physician Assessment)		Physician Assessment: Global Impression for Disease Severity (Global Physician Assessment)
Allergic Rhinitis (AR) using AR Visual Analog Scale (VAS)		Participant Assessment: Allergic Rhinitis (AR) using AR Visual Analog Scale (VAS)
Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)		Participant Assessment: Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)
Sino-Nasal Outcome Test (SNOT-22)		Participant Assessment: Sino-Nasal Outcome Test (SNOT-22)
Patient Oriented Eczema Measure (POEM)		Participant Assessment: Patient Oriented Eczema Measure (POEM)
Changes of Healthcare Utilization		Physician Assessment: Changes of Healthcare Utilization
Global Impression for Symptom Severity, Treatment Satisfaction (Global Patient Assessment)		Participant Assessment: Global Impression for Symptom Severity, Treatment Satisfaction (Global Patient Assessment)