Real Life Study of Biologicals in Patients With Severe CRSwNP
Recruiting · NCT05938972 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Hospital, Ghent
View the official record on ClinicalTrials.gov →Interventions studied
Mepolizumab
What this trial is about
This study is a pragmatic, real-life, observational study recruiting adult patients with chronic rhinosinusitis with nasal polyposis who are eligible to start biologicals as standard treatment. The aim of this study is to observe the long-term outcomes of biologicals in CRSwNP patients with or without comorbid asthma in 'real life'. Moreover, the investigators will gain insight into the mechanisms of biologicals in the local and systemic immunity of these patients and investigate novel local and systemic biomarkers and predictors of response.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Patients must meet the following criteria to be eligible for the enrolment in the study:
- Signed informed consent form (ICF),
- Age between 18 and 80 years at time of signing ICF,
- Able to comply with the study protocol, in the investigator's judgment,
- In group one: patients with severe allergic and/or eosinophilic asthma, defined by being currently treated with a biological (SoC) OR starting treatment with a biological (SoC).
- In group two: patients with CRSwNP with or without asthma, defined by starting treatment with a biological (SoC) and fulfill the criteria for reimbursement of a biological therapy
Exclusion criteria
- Patients who do not meet the reimbursement criteria of a biological therapy cannot participate in the study.
Where it is running
1 location listed.
- Ghent University Hospital - Ghent, Belgium