Assessing long-term outcomes of dupixent treatment in patients with chronic rhinosinusitis with nasal polyposis
- Conditions
- nasal polyps1003866710046304Inflammation of the nasal and paranasal sinus mucosa
- Registration Number
- NL-OMON53573
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 39
1. Patients >=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
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, such as short life
expectancy, substance abuse, severe cognitive impairment, or other medical,
social, or personal conditions and circumstances that can predictably prevent
the patient from adequately completing the schedule of visits and assessments
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 non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Descriptive summary of symptoms, HRQoL, and change over time<br /><br>• Descriptive summary of patients and disease characteristics with CRSwNP, and<br /><br>type 2 comorbidities </p><br>
- Secondary Outcome Measures
Name Time Method <p>• Descriptive summaries of DUPIXENT and other CRSwNP treatments used during the<br /><br>study, including most commonly used treatments, dosage, adherence,<br /><br>interruption, place, and frequency of administration (home or clinic)<br /><br>• Reasons for initiation of new CRSwNP treatment(s), concomitant therapies,<br /><br>treatment durations, and reasons for discontinuation and/or switching<br /><br>• Global assessment of disease severity and treatment satisfaction (patient and<br /><br>physician)<br /><br>• Descriptive summary of adverse events</p><br>