Complete Remission After Treatment With Biologics for Nasal Polyps
ConditionNasal Polyps
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
DUPIXENT®
DrugContinue Dupixent
NUCALA®
Drug"Continue Nucala
Dupi discontinuation
Other interventionStop taking Dupixent at baseline; no substitute is given
Mepo discontinuation
Other interventionStop taking Nucala at baseline; no substitute is given
Treatment groups
66 Participants
are divided into 4 treatment groupsGroup A: Arm 1: Continue Drug DActive comparator 1 intervention
Group B: Arm 2: Stop Drug DExperimental treatment 1 intervention
Group C: Arm 3: Continue Drug MActive comparator 1 intervention
Group D: Arm 4: Stop Drug MExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients who can continue being in complete remission being out of biologic treatment.
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.
Time frame
One year observatonSecondary outcomes
1
Is there any difference in what drug (Dupixent or Nucala) the patient was treated with before they stopped in the ability to obtain complete remission
When randomizing the patients they are stratified for what drug, they are treated with - Dupixent or Nucala. If some of the patients can be out of treatment for a year, thereby obtain-ing complete remission. Thus, the secondary outcome is to describe the percentage of pa-tients with complete remission who started on Dupixent and Nucala, respectively.
Time frame
One year observationSponsors and contacts
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Source ClinicalTrials.gov