Clinical trial NCT05938972: Real Life Study of Biologicals in Patients With Severe CRSwNP
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (between 18 and 80 years old) with severe allergic and/or eosinophilic asthma in group 1 and CRSwNP in group 2 that are receiving or will start to receive a biological as standard of care treatment, and agree on participating (signature of a written informed consent).

Brief summary: 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.

Detailed description: In this project, thanks to intense collaboration between the ENT department and the pulmonary diseases within the Allergy Network UZ Gent, the investigators set up a prospective study and biobank with the following aims:

* To observe and follow-up on clinical characteristics in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) with or without asthma. Primary outcomes will be the endoscopic total nasal polyp score (NPS) and the nasal symptom scores (SNOT-22, VAS, NCS and UPSIT).
* Identifying key nasal inflammatory biomarkers to predict therapeutic response to biologicals in CRSwNP patients (identification on blood samples, nasal secretions, small tissue biopsies and superficial scrapings before, during and at month 24 of treatment).
* Unravel the effects of biologicals in the local nasal immune regulation.
* Performing additional analyses to search for new biomarkers via complete proteomic analysis.

Using a unique combination of nasal sampling and state of the art biomarker discovery, the investigators believe this research will provide unprecedented insights which will aid the treatment of patients with biologicals.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical characteristics
timeFrame: 24 months
measure: Clinical characeristics
timeFrame: 24 months
measure: Local nasal immunity
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Philippe Gevaert, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: