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English Title: Tapering of biologics in CRSwNP Subtitle: Tapering of Mepolizumab or Dupilumab after 12 months of complete or partial disease control in patients with severe chronic rhinosinusitis with nasal polyposis – a national Danish RCT.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519758-35-01
Enrollment
135
Registered
2025-04-28
Start date
2025-05-27
Completion date
Unknown
Last updated
2025-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic rhinosinusitis with nasal polyps (CRSwNP)

Brief summary

In "controlled" patients presence of 0 & in "partly controlled" patients max. 2 of the following 7 items: 1) Nasal blockage: present on most days of the week, 2) Rhinorrhoea/postnasal drip: mucopurulent on most days of the week, 3) Facial pain/pressure: present on most days of the week, 4) Sense of smell: impaired, 5) Sleep disturbance or fatigue: present, 6) Nasal endoscopy: diseased mucosa, 7) Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment

Detailed description

1) changes in SNOT-22, ACQ and smell test scores from baseline to 52 weeks; 2) changes in disease control assessments from baseline to 52 weeks by given drug; and 3) baseline and demographic data such as: age, sex, comorbidities, BMI, level of education, duration of biologic treatment.

Interventions

DRUGMEPOLIZUMAB
DRUGDUPILUMAB

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
In "controlled" patients presence of 0 & in "partly controlled" patients max. 2 of the following 7 items: 1) Nasal blockage: present on most days of the week, 2) Rhinorrhoea/postnasal drip: mucopurulent on most days of the week, 3) Facial pain/pressure: present on most days of the week, 4) Sense of smell: impaired, 5) Sleep disturbance or fatigue: present, 6) Nasal endoscopy: diseased mucosa, 7) Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment

Secondary

MeasureTime frame
1) changes in SNOT-22, ACQ and smell test scores from baseline to 52 weeks; 2) changes in disease control assessments from baseline to 52 weeks by given drug; and 3) baseline and demographic data such as: age, sex, comorbidities, BMI, level of education, duration of biologic treatment.

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026