Understanding how inflammation affects smell in chronic rhinosinusitis
Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery
NA · Cliniques universitaires Saint-Luc- Université Catholique de Louvain · NCT06776042
This study is testing whether a new treatment for inflammation can help improve the sense of smell in people with chronic rhinosinusitis and nasal polyps.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain (other) |
| Locations | 1 site (Brussels) |
| Trial ID | NCT06776042 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate the mechanisms behind olfactory dysfunction in patients with chronic rhinosinusitis with nasal polyps. It will assess whether type 2 inflammation impacts the regeneration of the olfactory epithelium and if a treatment targeting T2 inflammatory cytokines can influence olfactory dysfunction. Participants will undergo olfactory testing and nasal brushing before and after a 3-month treatment period to evaluate changes in their sense of smell. The study focuses on understanding the relationship between inflammation and olfactory recovery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 with chronic rhinosinusitis and olfactory dysfunction.
Not a fit: Patients with active smoking habits, immune deficiencies, or certain nasal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for patients suffering from smell loss due to chronic rhinosinusitis.
How similar studies have performed: While the specific approach may be novel, similar studies have shown promise in understanding the relationship between inflammation and olfactory function.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brussels
- Cliniques Universitaires Saint-Luc — Brussels, Belgium (RECRUITING)
Study contacts
- Principal investigator: Valérie Hox, MD, PhD — Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study coordinator: Valérie Hox, MD, PhD
- Email: valerie.hox@saintluc.uclouvain.be
- Phone: +3227648675
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.
Conditions: Chronic Rhinosinusitis With Nasal Polyps