Frontlight ResearchEarly access
CompletedPhase 4
Mechanisms of Smell Improvement With Dupilumab.
Key facts
- Who runs it
- Medical University of South Carolina
- Where
- Charleston and Charlottesville, United StatesSee the 2 sites
- Trial code
- Status
- Completed
- Phase
- Phase 4
- People taking part
- 60 people enrolled
- Started
- 10 Aug 2023
- Ended
- 30 Jan 2025
- Type of study
- Interventional
- Treatments tested
- Dupilumab
- Record updated
- 5 August 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Adults ≥18 years of age
- Meet criteria for CRSwNP as defined by ICAR-21
- 2 out of 4 cardinal symptoms for ≥12 weeks
- Visible evidence of inflammation on endoscopy or imaging
- Bilateral visible nasal polyps ≥1 in each nasal cavity (0-4 scale each side)
- Olfaction score ≥1 (0-3 scale)
- Candidate for treatment with dupilumab for CRSwNP
- Elected to proceed with dupilumab for treatment of CRSwNP
Who cannot take part
- Prior use of dupilumab
- Previous treatment with another biologic medication for CRSwNP or asthma within 6 months
- Any nasal or sinus surgery within the last 3 months
- Oral corticosteroid use within the last 1 month
- Presence of antrochoanal nasal polyps; acute rhinosinusitis; upper respiratory infection
- Allergic granulomatous angiitis/eosinophilic granulomatosis with polyangiitis
- Granulomatosis with polyangiitis; cystic fibrosis; Young syndrome
- Kartagener syndrome; or dyskinetic cilia syndrome
- Current pregnancy, breast-feeding, or plan to become pregnant during next 3 months
- Poorly controlled asthma
Where in United States
- Medical University of South CarolinaCharleston, United States
- University of VirginiaCharlottesville, United States
About the trial
What the trial wants to find out
This study seeks to explore the mechanism through which dupilumab improves olfactory cleft inflammation in patients with chronic sinusitis with nasal polyps (CRSwNP). The investigators expect this study to provide convincing evidence that dupilumab improves clinical olfaction via direct reduction in olfactory cleft inflammation.
The group in the trial
- TreatmentTreatment being tested
The treatment group will receive dupilumab at 300mg SC Q2weeks. The first dose will be administered via subcutaneous injection in clinic at baseline. Subjects will self-administer study drug (dupilumab 300 mg) subcutaneous every 2 weeks after initial dosing at visit 2.
Treatment: Dupilumab
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Mechanisms of Smell Improvement With Dupilumab
- Record updated
- 5 August 2026