Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05598814
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2022-10-25
Brief Title:
Mepolizumab to CRSwNP Through 12 Months - Randomised to FESS and Non-FESS Within the First 2 Weeks
Sponsor:
Vibeke Backer
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Optimisation of Treatment in Patients With CRSwNP An RCT of Mepolizumab and Surgical Treatment With FESS and Mepolizumab Versus Only Mepolizumab Over a 6- and 12-month Follow-up
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial will compare treatment in patients with chronic rhinosinusitis with nasal polyps CRSwNP and asthma The patients will be randomized to treatment with the biologic drug Mepolizumab or the biologic drug Mepolizumab combined with Functional Endoscopic Sinus Surgery FESS
The aim of this study is to evaluate the effect of combined treatment with biologic treatment and surgery vs biologic treatment only
The hypothesis is that surgical removal of polyps and inflamed tissue from the nasal sinuses will increase the effect of the biologic treatment leading to a lower disease burden after 6 months of treatment compared with biologic drugs only Furthermore combined biologics and surgery will keep a lower disease burden and better general health after 12 months of treatment than biologics alone
Inclusion criteria
Patients 18 years old at the time of signed informed consent no upper limit
Patients who are referred to the outpatient clinic for the following reasons
Doctors diagnosis of CRS
NPS 22 out of a score of 8 max
Severity measured as an SNOT22 score 35
One FESS in general anaesthesia performed prior to inclusion no time limitations
No course of systemic steroids within the last 3 months whereas a daily low dose is allowed
Possible doctors diagnosis of asthma
Type 2 inflammation
Exclusion criteria
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
Patients who have previously or currently received biologics for CRS or asthma
Patients who are not able to give informed consent ie patients who are permanently incapable
Patients who meet 1 of the following
Malignant lung disease
Cardiac disease of clinical importance
Current pregnancy and breastfeeding as well as planning to be pregnant in the near future
Unwillingness to have FESS performed
Patients needing FESS or systemic steroids OCS during the study period will be excluded after an unscheduled visit last observation carried forward LOCF
Patients who are not eligible because of the investigators judgement
The effect of the treatment will be evaluated with objective procedures and questionnaires related to CRSwNP and asthma after 3 6 and 12 months
The aim of this study is to evaluate the effect of combined treatment with biologic treatment and surgery vs biologic treatment only
The hypothesis is that surgical removal of polyps and inflamed tissue from the nasal sinuses will increase the effect of the biologic treatment leading to a lower disease burden after 6 months of treatment compared with biologic drugs only Furthermore combined biologics and surgery will keep a lower disease burden and better general health after 12 months of treatment than biologics alone
Inclusion criteria
Patients 18 years old at the time of signed informed consent no upper limit
Patients who are referred to the outpatient clinic for the following reasons
Doctors diagnosis of CRS
NPS 22 out of a score of 8 max
Severity measured as an SNOT22 score 35
One FESS in general anaesthesia performed prior to inclusion no time limitations
No course of systemic steroids within the last 3 months whereas a daily low dose is allowed
Possible doctors diagnosis of asthma
Type 2 inflammation
Exclusion criteria
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
Patients who have previously or currently received biologics for CRS or asthma
Patients who are not able to give informed consent ie patients who are permanently incapable
Patients who meet 1 of the following
Malignant lung disease
Cardiac disease of clinical importance
Current pregnancy and breastfeeding as well as planning to be pregnant in the near future
Unwillingness to have FESS performed
Patients needing FESS or systemic steroids OCS during the study period will be excluded after an unscheduled visit last observation carried forward LOCF
Patients who are not eligible because of the investigators judgement
The effect of the treatment will be evaluated with objective procedures and questionnaires related to CRSwNP and asthma after 3 6 and 12 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None