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

JRCT ID: jRCT1031210642

Registered date:03/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic rhinosinusitis with nasal polyposis (CRSwNP)
• Date of first enrollment: 21/08/2021
• Target sample size: 50
• Countries of recruitment: Canada,Japan,United states,Japan,,Japan
• Study type: Observational

Outcome(s)

Primary Outcome

- Baseline Patient Characteristics
- Baseline Disease Characteristics

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Administrator Clinical Trials
• Secondary Sponsor: Regeneron Pharmaceuticals,Sanofi K. K.
• Secondary ID(s): NCT04959448,EUPAS41565