Dupi discontinuation: Stop taking Dupixent at baseline; no substitute is given
Mepo discontinuation: Stop taking Nucala at baseline; no substitute is given
Study summary
In this RCT the investigators randomize patients who are treated with biologic treatment (Nucala or Dupixent) due to nasal polyps and have controlled disease within the last year to either stop treatment og continue as a control group.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
5.1 Inclusion criteria (all must be fulfilled)
Inclusion criteria:
At the time when the patient started biological treatment, they must have fulfilled the EPOS criteria for initiation of biologic treatment (REF EPOS):
* Fulfil the criteria for CRSwNP
* Presence of bilateral polyps in a patient
* Had ESS (sinus surgery) (exceptional circumstances excluded)
* Fulfil at least three of the following five criteria Evidence of type 2 inflammation Need for (and treated with) systemic corticosteroids or contraindication to these SNOT-22 score of 40 or above Significant loss of smell Asthma needing regular inhaled corticosteroids
To enter this study, the patient must be:
* Above 18 years of age
* Currently be in treatment with either Dupilumab (300 mg) or Mepolizumab (100 mg) with treatment every fourth week. This treatment should have been stable/unchanged for at least three months.
* Within the latest year, the patient must at all times have scored all the below symptoms of CRS five or below on a VAS scale from 0 - 10 - Doing this, it is according to the EPOS defined as controlled disease. The items are: nasal blockage, rhinorrhea/postnasal drip, facial pain/pressure, smell, sleep disturbance or fatigue) Please view appendix 2.
* Within the latest year the nasal endoscopy cannot have showed polyp score of more than 1+1 out of 4+4, further, no thick secretions or general oedema must have been present.
* Within the latest year the patient is not allowed to have had ESS or rescue treatment for their CRSwNP (antibiotics or systemic steroids)
* The patient must be able to understand Danish and able to sign an informed content.
Exclusion Criteria:
* In the twelve months of remission the patient is not allowed to have had AECRS (acute exacerbation of chronic rhinosinusitis). A common cold is allowed.
* Polyp removal in the out-patient clinic may not have been performed within the last 3 months.
* In the twelve months of remission the patient cannot at any time have scored higher than 1.2 on the ACQ questionnaire, meaning that the patient does not have uncontrolled asthma (Appendix 3).
* Patients who, because of language barriers, are not able to understand 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 (LOCF) - active IVF treatment. (Please look belove)
* Patients who have or recently have had illness, such as cancer that or its treatment is expected to significantly affect morbidity and/or quality of life in the next two years
* Unwillingness to follow the study procedure
* Hypersensitivity to any of either Dupilumab or Mepolizumab.
Primary outcome measure(s)
Number of patients who can continue being in complete remission being out of biologic treatment. — One year observaton It is known that some asthma patients after years of treatment can stop taking biologics without regaining symptoms. Further, studies have shown that a lot of patients can be without symptoms taking biologics every 12th week.
The definition of being in control, also called complete remission, is: not scoring higher than 5 (range 0 -10) on a Visual Analogue Scale (VAS) on nasal blockage, rhinorrhea, facial pressure, decreased smell or sleep; 0 being no symptoms and 10 being worst imaginable further no antibiotics, systemic steroids or surgery should be needed and the nasal examination must also be unchanged.
The primary outcome is to observe how many, if any, patients can stop their biologic treatment still being in complete remission. This is evaluated by VAS questionnaires and nasal endoscopy every third month or even more frequent if the patient has symptoms.
This is compared with the control group that has the same follow-up regime.
Trial sites (6)
Facility
City
Region
Status
Rigshospitalet
Copenhagen
Region H
Recruiting
Nordsjællands hospital
Hillerød
Region H
Recruiting
Køge øre næse hals afd
Køge
Region Sj
Recruiting
Dept. of otorhinolaryngology, Odense
Odense
Region Syd
Recruiting
Vejle sygehus
Vejle
Region S
Recruiting
Gødstrup Hospital
Gødstrup
Denmark
Recruiting
More Copenhagen University Hospital, Rigshospitalet trials in Denmark
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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