Real Life Study of Biologicals in Patients With Severe CRSwNP

NCT05938972 | Recruiting

• 1 other identifier: ONZ-2022-0033
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

Primary Outcomes (3)

• 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. 1. VAS symptom score: minimum of 0 to maximum of 100. Higher VAS-scores indicate worse symptoms. 2. SNOT-22 score: a validated, self-administered questionnaire that is used to assess CRS patients. It consists of 22 items, rated from 0 ('no problem at all') to 5 ('worst possible symptom'). Possible SNOT-22 total scores range from 0 to 110, with higher SNOT-22 total scores indicating worse symptoms

  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

Interventions

Mepolizumab BIOLOGICAL

Monoclonal antibodies

Also known as: Omalizumab, Dupilumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Patients who do not meet the reimbursement criteria of a biological therapy cannot participate in the study.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples, nasal secretions and small tissue biopsies

MeSH Terms

Interventions

mepolizumab; Omalizumab; dupilumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Philippe Gevaert, Prof. Dr.

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manon Blauwblomme, Masters

CONTACT

+32 09 332 23 98; manon.blauwblomme@ugent.be

Philippe Gevaert, Prof. Dr.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 11, 2023
• Study Start: March 1, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

BE (1)