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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.
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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepolizumab | Biological | Monoclonal antibodies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical characteristics | Endoscopic total nasal polyp score to quantify nasal polyps with endoscopy. The higher the score, the more polyps are present in the nose. A unilateral score from 0 (absence of polyps) to 4 is given. The total nasal polyp score is the sum of the scores for both nostrils, thus ranging from 0 to 8, and is based on the continuous extension of nasal polyps beyond clear landmarks such as the upper and lower borders of the middle and inferior turbinate. This implies that a score can only be attributed if the criteria of the lower scores are met. E.g. a unilateral score of 3 cannot be given without nasal polyps also meeting the criteria for a score of 2, and similarly, a score of 4 cannot be given without having a score of 3. | 24 months |
| Clinical characeristics | Nasal symptom scores: VAS symptom scores and SNOT-22 questionnaire will be recorded through a questionnaire. The need for surgery or rescue medication (e.g. Systemic corticosteroids, antibiotics,..) will be recorded each study visit.
| 24 months |
| Local nasal immunity | Nasal secretions will be harvested at each visit. Merocels (IVALON 4000 Plus 3,5 x 0,9 x 1,2 cm surgical products Fabco, New London, CT) will be placed in each nostril for 5 minutes and will be stored at -20°C until analysis. Key inflammatory markers will be measured: ECP, IL-5, sIL-5Rα, total IgE, periostin, total lambda- and kappa-FLC concentrations, MMP-9 and MPO. Additional analyses will then be performed to search for new biomarkers via complete proteomic analysis. | 24 months |
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Inclusion Criteria:
Patients must meet the following criteria to be eligible for the enrolment in the study:
Exclusion Criteria:
Patients who do not meet the reimbursement criteria of a biological therapy cannot participate in the study.
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manon Blauwblomme, Masters | Contact | +32 09 332 23 98 | manon.blauwblomme@ugent.be | |
| Philippe Gevaert, Prof. Dr. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Philippe Gevaert, Prof. Dr. | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Recruiting | Ghent | 9000 | Belgium |
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| ID | Term |
|---|---|
| C434107 | mepolizumab |
| D000069444 | Omalizumab |
| C582203 | dupilumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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blood samples, nasal secretions and small tissue biopsies
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |