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New treatment option for Chronic Rhinosinusitis With Nasal Polyps
Official title Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps
ClinicalTrials.gov ID: NCT07187583
What this study is testing
What is increased dosing interval of biological therapy?
increased dosing interval of biological therapy is an investigational medicine, being studied as a potential treatment for chronic rhinosinusitis with nasal polyps.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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...
- Nasal blockage: present on most days of the week
You likely can't join if
- 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)
See the full eligibility 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...
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
- Aarhus, Denmark
- Copenhagen, Denmark
- Esbjerg, Denmark
- Herning, Denmark
- Hillerød, Denmark
- Køge, Denmark
- Odense, Denmark
- Vejle, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark; Aarhus, Denmark; Copenhagen, Denmark; Esbjerg, Denmark; Herning, Denmark; Hillerød, Denmark and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.