Nasal Polyps Clinical Trials

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English Title: Complete Remission Study Subtitle: Discontinuation of Mepolizumab or Dupilumab After at Least 12 Months Without Symptoms in Patients With Severe Chronic Rhinosinusitis With Polyps - a National Danish RCT Study

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1 Inclusion criteria (all must be fulfilled)

⁃ 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.

Locations
Other Locations
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Gødstrup Hospital
RECRUITING
Gødstrup
Nordsjællands hospital
RECRUITING
Hillerød
Køge øre næse hals afd
RECRUITING
Køge
Dept. of otorhinolaryngology, Odense
RECRUITING
Odense
Vejle sygehus
RECRUITING
Vejle
Contact Information
Primary
Kasper Aanæs, md, phd
kasperaanaes@hotmail.com
60708594
Time Frame
Start Date: 2025-04-03
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 66
Treatments
Active_comparator: Arm 1: Continue Drug D
Participants continue their usual treatment with Drug Dupi throughout the study.
Experimental: Arm 2: Stop Drug D
Participants discontinue Drug Dupi at baseline and receive no active treatment during the study.
Active_comparator: Arm 3: Continue Drug M
Participants continue their usual treatment with Drug Mepo throughout the study.
Experimental: Arm 4: Stop Drug M
Participants discontinue Drug Mepo at baseline and receive no active treatment during the study.
Sponsors
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov