Observational study on biological treatments for severe chronic rhinosinusitis with nasal polyps
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
This study is looking at how well new biological treatments work for adults with severe chronic sinus issues and nasal polyps, while also checking how these treatments affect symptoms over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Trial ID | NCT05938972 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with severe CRSwNP who are starting biological treatment and meet reimbursement criteria.
Not a fit: Patients who do not meet the reimbursement criteria for biological therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with severe CRSwNP, enhancing their quality of life.
How similar studies have performed: While this approach is observational and builds on existing knowledge, similar studies have shown promise in understanding the effects of biologicals in chronic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ghent
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.