RecruitingNot Applicable

Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery

Belgium140 participantsStarted 2023-05-22

Plain-language summary

The goal of this clinical trial is to understand the mechanisms leading to olfactory dysfunction (OD) in chronic rhinosinusitis (CRS). The main questions it aims to answer are: * Is the type 2 inflammation impacting the olfactory epithelium regeneration, leading to OD? * Does a treatment interfering with one of the major T2 inflammatory cytokines, have an impact on the mechanisms of OD in CRS? Participants will undergo olfactory testing and nasal brushing before and after 3 months of treatment.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * At least two of the following symptoms: nasal obstruction, rhinorrhoea, smell loss, facial pain for 12 weeks. * Endoscopic visualisation of bilateral sinonasal polyps * SSI (TDI) \< 30.75 and decreased sense of smell subjectively * Eosinophilia \> 300/μl of blood Ku/l * On a stable nasal steroid treatment for at least 4 weeks Exclusion Criteria: * Active smoking * Primary and secondary immune deficiencies * Ciliary diseases (cystic fibrosis, primary ciliary diskinesia) * History of or current nasal malignancies * \< 18 years and \> 70 years * Patients unable to express consent * Use of systemic corticosteroids for \< 4 weeks before visit 1 • Use of systemic or local antibiotics for \< 4 weeks before visit 1

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Genetic profile comparison after single-cell RNA sequencing

Timeframe: Through study completion, an average of 2 years

Trial details

NCT IDNCT06776042

SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Valérie Hox, MD, PhD

+3227648675 valerie.hox@saintluc.uclouvain.be

View on ClinicalTrials.gov More Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) trials