Observational study on biological treatments for severe chronic rhinosinusitis with nasal polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to recruit adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who are eligible to start biological treatments. It will follow these patients over time to assess the long-term outcomes of biological therapies, including their effects on nasal symptoms and polyp scores. The study will also investigate local and systemic biomarkers to predict responses to treatment and explore the mechanisms of biologicals in immune regulation. Collaboration between the ENT and pulmonary departments will enhance the study's insights into patient care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ghent University Hospital
  Ghent, Belgium Recruiting

Study contacts

• Principal investigator: Philippe Gevaert, Prof. Dr. — University Hospital, Ghent
• Study coordinator: Manon Blauwblomme, Masters
• Email: manon.blauwblomme@ugent.be
• Phone: +32 09 332 23 98

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mepolizumab with or without in-office nasal polypectomy for chronic rhinosinusitis with nasal polyps

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• Tezepelumab for Chinese adults with nasal polyps: a 24-week treatment study

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• Reducing how often biologic injections are given for chronic nasal polyps

  This study will test whether spacing out mepolizumab or dupilumab injections to every 6–8 weeks keeps symptoms controlled in adults with partly controlled chronic rhinosinusitis with nasal polyps.

  Recruiting at 3 sites Phase 4 Copenhagen University Hospital, Rigshospitalet · Aalborg and 8 other locations · NCT07187583

• Sinonasal microbiome transplant for chronic rhinosinusitis

  This will try a sinonasal microbiome transplant to see if it reduces symptoms in people with chronic rhinosinusitis with or without nasal polyps.

  Recruiting Phase 2/3 Region Skane · Helsingborg · NCT07184684

• SHR-1905 injection for chronic rhinosinusitis with nasal polyps

  This trial will test whether SHR-1905 injections help adults with chronic rhinosinusitis with nasal polyps reduce polyp size and symptoms compared with placebo.

  Recruiting Phase 3 Guangdong Hengrui Pharmaceutical Co., Ltd · Shanghai, Shanghai Municipality · NCT07132827

• Investigating the effects of Dupilumab on nasal barrier function in chronic rhinosinusitis patients

  This study is testing if the medication Dupilumab can improve the nasal barrier function in people with chronic rhinosinusitis, especially those with nasal polyps.

  Recruiting Medical University of Vienna · Vienna, Austria · NCT06398873

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.