RECRUITINGOBSERVATIONAL
Real Life Study of Biologicals in Patients With Severe CRSwNP
Real Life Study Assessing Long Term Outcomes and Predictive Factors of Response to Biologicals in Patients With Severe CRSwNP and/or Severe Allergic and/or Eosinophilic Asthma
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
Patients must meet the following criteria to be eligible for the enrolment in the study:
- Signed willing to sign a consent form 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
Who Should NOT Join This Trial:
Patients who do not meet the reimbursement criteria of a biological therapy cannot participate in the study.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
BIOLOGICAL
Mepolizumab
Monoclonal antibodies
Locations (1)
Ghent University Hospital
Ghent, Belgium