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Effect of dupilumab on olfactory function in patients with chronic rhinosinusitis with nasal polyps

Effect of dupilumab on olfactory function in patients with chronic rhinosinusitis with nasal polyps

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009848
Enrollment
40
Registered
2024-10-16
Start date
2024-09-02
Completion date
Unknown
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Biological/Vaccine, Non-Stem Cell : Study patients are administered dupilumab (300 mg subcutaneously every 2 weeks) for 24 weeks and then are observed for 12 weeks after dupilumab discontinuat

Sponsors

Sanofi-Aventis Korea
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Age: 18-70 years • Chronic rhinosinusitis with bilateral nasal polyps • Ongoing symptoms despite of intranasal corticosteroid therapy - Received systemic corticosteroids (= 2 times) in the preceding 1 years or - Received previous sinonasal surgery (within recent 10 years)

Exclusion criteria

Exclusion criteria: • A history of traumatic brain injury or cerebral diseases, including dementia • Received any biologics including dupilumab within 4 months prior to the study entry • Received systemic steroids due to any medical conditions within 4 weeks prior to the study entry except who maintained low dose steroids for more than 6months

Design outcomes

Primary

MeasureTime frame
olfactory function

Secondary

MeasureTime frame
cognitive function, auditory function, CRS symptoms (sino-nasal outcome test-22), EuroQol-5 dimension

Countries

Korea, Republic of

Contacts

Public ContactYoung- Hee Nam

Dong-A University Hospital

dr00nam@daum.net+82-51-240-5974

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026