Investigating the effects of Dupilumab on smell in patients with nasal polyps
The 'Real World' Olfactory Outcomes Treating Nasal Polyposis With Dupilumab
This study is testing if Dupilumab can improve the sense of smell in adults with nasal polyps over six months.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Drugs / interventions | Dupilumab |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT04869436 on ClinicalTrials.gov |
What this trial studies
This study examines how Dupilumab treatment affects the sense of smell in adults suffering from chronic rhinosinusitis with nasal polyps. Participants will undergo olfactory testing using the Sniffin' sticks test at three different time points: baseline, 3 months, and 6 months after starting treatment. The primary focus is on measuring changes in the olfactory TDI score, while secondary outcomes include nasal polyp scores and quality of olfactory disorder symptoms. A total of 27 patients will be enrolled and monitored throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with chronic rhinosinusitis and nasal polyps who experience olfactory loss and have a clinical indication for Dupilumab treatment.
Not a fit: Patients with olfactory loss due to causes other than chronic rhinosinusitis, such as malignancies or trauma, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding of how Dupilumab enhances olfactory function in patients with nasal polyps.
How similar studies have performed: While there is ongoing research into Dupilumab's effects on nasal polyps, this specific focus on olfactory outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients older than 18 years old * Chronic rhinosinusitis with Nasal Polyps * Olfactory loss * Clinical indication for treatment with Dupilumab Exclusion Criteria: Patients with olfactory loss from other causes such as: * Sinonasal malignancies * Trauma * Idiopathic olfactory loss * Use of cocaine * COVID-19 related olfactory loss * Pregnancy
Where this trial is running
London, Ontario
- St. Joseph's Health Care — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Leigh J Sowerby, MD, FRCS — St. Joseph's Hospital London, ON, Canada
- Study coordinator: Cristian Dihel, MD
- Email: cristian.dihel@sjhc.london.on.ca
- Phone: +15196466100
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.