MONOPOLY: predicting clinical benefit of dupilumab in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP)

Phase 4

Recruiting

• Conditions: CRSwNP; 10046304; chronic rhinosinusitis with nasal polyps

• Registration Number: NL-OMON54163
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 130

Inclusion Criteria

bilateral CRSwNP (EPOS2020 criteria)
>= 18 years
indication for biological (EPOS2020 criteria) and starting treatment with
dupilumab
(for EPOS 2020 criteria see reference in METC protocol)

Exclusion Criteria

• age < 18 years
• pregnancy
• patient is not able to complete SNOT-22 questionnaire in NL or EN
• strong indication for surgical treatment (e.g.: mucoceles)
• systemic diseases affecting the nose (e.g.: GPA, EGPA, sarcoid, primary
ciliary dyskinesia, cystic fibrosis)
• antrochoanal polyps (isolated benign polyps originating from the mucosa of
the maxillary sinus with a distinctive small stalk)
• inverted papilloma and malignant polyps
• acute upper or lower respiratory tract infections within 2 weeks before the
inclusion visit
• use of systemic corticosteroids within 4 weeks before the inclusion visit
• need of continuous systemic corticosteroid treatment for other disease than
CRSwNP
• systemic diseases preventing participation in the study (all comorbidities
that have a higher impact on quality of life than CRSwNP and/or making the
patient at risk during the study period)
• other systemical medical treatments influencing disease or primary and
secondary study outcome measurements such as (non-)selective immunosuppressants
(e.g.: azathioprine, methotrexate), excluding co-treatment with other type-2
targeting
biologicals for indication of CRSwNP and/or Asthma.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Histochemical and single cell suspension flow cytometry analysis</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>does not apply</p><br>