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
Qualifiers
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
Treatments tested in this trial
- DUPIXENT®
- NUCALA®
- Dupi discontinuation
- Mepo discontinuation
Treatment groups
66 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov