Real Life Study of Biologicals in Patients With Severe CRSwNP

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

— NASUMAB  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938972
• Other study ID #: ONZ-2022-0033
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2024
• Source: University Hospital, Ghent
• Contact: Manon Blauwblomme, Masters
• Phone: +32 09 332 23 98
• Email: manon.blauwblomme[@]ugent.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps
• Rhinosinusitis

Intervention

Biological:
• Mepolizumab
Monoclonal antibodies

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.; VAS symptom score: minimum of 0 to maximum of 100. Higher VAS-scores indicate worse symptoms.; 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
Primary	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-5Ra, 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