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NCT Number: NCT05938972

Real Life Study of Biologicals in Patients With Severe CRSwNP

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.

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

Manon Blauwblomme, Masters

CONTACT

[email protected]

+32 09 332 23 95

Philippe Gevaert, Prof. Dr.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mepolizumab

Biological

Monoclonal antibodies

Other names: Omalizumab, Dupilumab

Primary outcomes

  1. Clinical characteristics

    Time frame: 24 months

    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.

  2. Clinical characeristics

    Time frame: 24 months

    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

  3. Local nasal immunity

    Time frame: 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Manon Blauwblomme, Masters

CONTACT

[email protected]

+32 09 332 23 98

Philippe Gevaert, Prof. Dr.

CONTACT

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study 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

Acronym: NASUMAB

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Jul 11, 2023
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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