Nasal Polyps Clinical Trials

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Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of this study is to investigate the feasibility of extending the dosing intervals of biological therapies while maintaining optimal treatment effects in chronic rhinosinusitis with nasal polyps (CRSwNP).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥18 years of age.

• Currently receiving treatment with either dupilumab (300 mg) or mepolizumab (100 mg) every four weeks.

• Having received the biologic at unchanged dosing interval for at least three months.

• For at least one year during treatment with biologics, the patients' CRSwNP must be categorized as partly controlled as defined by presence of 1-2 of the following seven items (also available in EPOS 2020 table in protocol):

‣ Nasal blockage: present on most days of the week

⁃ Rhinorrhoea/postnasal drip: mucopurulent on most days of the week

⁃ Facial pain/pressure: present on most days of the week

⁃ Sense of smell: impaired

⁃ Sleep disturbance or fatigue: present

⁃ Nasal endoscopy: diseased mucosa

⁃ Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment

∙ of which 1-5 will be scored by the patient using VAS (0-10) and noted above 5.

Locations
Other Locations
Denmark
Dept of otorhinolaryngology, Aalborg University Hospital
NOT_YET_RECRUITING
Aalborg
Dept of otorhinolaryngology, head and neck surgery, Aarhus University Hospital
NOT_YET_RECRUITING
Aarhus
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University, Rigshospitalet
RECRUITING
Copenhagen
Esbjerg Og Grindsted Sygehus
NOT_YET_RECRUITING
Esbjerg
Dept of otorhinolaryngology, Gødstrup Regional Hospital
NOT_YET_RECRUITING
Herning
Dept of otorhinolaryngology, Nordsjaellands Hospital
RECRUITING
Hillerød
Dept of otorhinolaryngology, Sjællands Universitetshospital
RECRUITING
Køge
Dept of otorhinolaryngology, Odense University Hospital
NOT_YET_RECRUITING
Odense
Dept of otorhinolaryngology, Lillebaelt Hospital
NOT_YET_RECRUITING
Vejle
Contact Information
Primary
Elizabeth M. Stevens Saporito, MD
este0027@regionh.dk
+4535452370
Time Frame
Start Date: 2025-06-05
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 135
Treatments
No_intervention: Standard dosing of biological therapy
Continues dosing of mepolizumab (100 mg via injection pen, subcutaneous injection) or dupilumab (300 mg via injection pen, subcutaneous injection) every 4 weeks.
Active_comparator: Increased dosing interval of biological therapy
Increases to a 6-week dosing interval at baseline - of mepolizumab (100 mg via injection pen, subcutaneous injection) or dupilumab (300 mg via injection pen, subcutaneous injection) - and if response to therapy is maintained, increases to 8-week dosing intervals at the follow-up visit in week 26. Thereafter, dosing every 8 weeks is maintained until the patient completes the trial at week 52.
Sponsors
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov