A Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chr… (NCT05942222) | Clinical Trial Compass
Active — Not RecruitingPhase 4
A Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chronic Rhinosinusitis With Nasal Polyps
Denmark220 participantsStarted 2023-04-27
Plain-language summary
The goal of this randomized clinical trial is to compare the effects of two newly available biological drugs for the treatment of severe chronic rhinosinusitis with nasal polyps in Danish patients.
The main questions it aims to answer are whether the two drugs are comparable in effect after 24 weeks in terms of:
* A subjective score (the SNOT-22)
* An objective score, i.e.the physician-assessed score of nasal polyp size (the Nasal Polyp Score (0-8))
Methods:
Participants will be randomized to receive one of the IMPs drug in the standard dose. After 24 weeks the effect is assessed by subjective and objective measures. If the criteria set by the Danish Medicinal Council are met (see elsewhere), treatment continues with the same drug for an additional 24 weeks. If the effect criteria are not met, the subject crosses-over to the opposite drug for an additional 24 weeks. After 48 weeks the effect is assessed once more.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Bilateral polyps in nose and sinuses
* ESS within the last three years (unless unfit for surgery y- in this study defined as either a severe somatic disease, for which other specialist advise against surgery, e.g., cardiac disease, pulmonary disease, or coagulation disorder OR/AND severe anxiety which can either be due to previous traumatic experiences with surgery or the postoperative period, post-traumatic stress disorder or severe anxiety disorder. In cases of doubt, investigators can ask for a written statement from the general practitioner or a psychiatrists/psychologist))
* Optimal local treatment with saline irrigation and topical nasal steroids for at least three months (unless contraindicated)
* Evidence of type 2 inflammation
Furthermore, patients must fulfil three out the following five criteria:
* Need for systemic corticosteroids (at least two courses/year OR long-term treatment \>3 months) or contraindication to systemic steroids
* Significantly impaired QoL (SNOT-22 score≥50)
* Significant LoS (SSIT-16 score 0-8)
* NPS ≥5 (with at least 2 on either side)
* Asthma diagnosis (requiring inhaled corticosteroid (ICS))
Also: Age of 18 years or more and able to read and/or speak Danish
Exclusion criteria
* Systemic corticosteroid treatment within the last three months
* Endoscopic sinus surgery (ESS) within the last six months
* Non-adherent to medicine regimens
* Hypersensitivity to the active substance or any of the excipients in the two …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.