Status:
COMPLETED
Directed Topical Drug Delivery for Treatment for PASC Hyposmia
Lead Sponsor:
Duke University
Conditions:
Post Acute Sequelae Covid-19 Hyposmia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II randomized, double-blinded, placebo-controlled study to evaluate the efficacy of topical intranasal treatment of beclomethasone vs. placebo for improved olfactory function.
Detailed Description
Eligible participants are randomized to receive either Beclomethasone or placebo intranasally via a microsponge twice on day 1 and day 14. Study duration is three months and includes 4 in-person study...
Eligibility Criteria
Inclusion
- Post-COVID hyposmia lasting greater than 3 months following COVID19 by history
- Male or female, aged 18 years or older
Exclusion
- Pregnancy or lactation
- Known allergic reactions to components of microsponge (including shellfish) or to beclomethasone
- Known diagnosis of glaucoma
- Febrile illness within 1 week
- Treatment with another investigational drug or other intervention within 3 months
- Active sinonasal disease by nasal exam, i.e. rhinosinusitis, nasal polyps
- Adults unable to consent
- Prisoners, employees or subordinates
- Individuals who are not yet adults (infants, children, teenagers)
Key Trial Info
Start Date :
September 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05970731
Start Date
September 5 2023
End Date
October 7 2024
Last Update
December 2 2024
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710