increased dosing interval of biological therapy: Increasing dosing interval of biological therapy for CRSwNP from every 4 weeks to every 6 weeks and if continued satisfactory response then to every 8 weeks.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* ≥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):
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
of which 1-5 will be scored by the patient using VAS (0-10) and noted above 5.
Exclusion Criteria:
* Patients with excellent response to biologics (0 of the above-mentioned 7 items for partly controlled disease)
* Patients with no or limited response to biologics (\>2 of the above-mentioned 7 items for partly controlled disease)
* Patients with a cancer diagnosis deemed by the investigator to preclude participation in the trial
* Patients who, because of language barriers, are not able to understand Danish written information and, thus, are not able to answer questionnaires
* Patients who currently receive biologics for any other disease (asthma not included)
* Patients who are not able to give informed consent (i.e., patients who are permanently incapable)
* Patients who are not eligible because of the investigator's judgement
* Patients who experience pregnancy during the study will be excluded after an unscheduled visit - active IVF treatment (please see below)
* Unwillingness to follow the study procedure
Primary outcome measure(s)
The percentage of patients achieving sustained partly controlled disease after tapering of biologics for CRSwNP — from enrollment (week 0) to week 52. "partly controlled" as defined by presence of 1-2 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
Trial sites (9)
Facility
City
Region
Status
Dept of otorhinolaryngology, Aalborg University Hospital
Aalborg
Denmark
Not Yet Recruiting
Dept of otorhinolaryngology, head and neck surgery, Aarhus University Hospital
Aarhus
Denmark
Not Yet Recruiting
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University, Rigshospitalet
Copenhagen
Denmark
Recruiting
Esbjerg Og Grindsted Sygehus
Esbjerg
Denmark
Not Yet Recruiting
Dept of otorhinolaryngology, Gødstrup Regional Hospital
Herning
Denmark
Not Yet Recruiting
Dept of otorhinolaryngology, Nordsjaellands Hospital
Hillerød
Denmark
Recruiting
Dept of otorhinolaryngology, Sjællands Universitetshospital
Køge
Denmark
Recruiting
Dept of otorhinolaryngology, Odense University Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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