Clinical trial
Directed Topical Drug Delivery for Treatment for PASC Hyposmia
Name
Pro00113299
Description
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.
Trial arms
Trial start
2023-09-05
Estimated PCD
2024-09-01
Trial end
2024-09-01
Status
Recruiting
Phase
Early phase I
Treatment
Beclomethasone
84 mcg of Beclomethasone administered topically on an intranasal microsponge, placed in the olfactory cleft using a nasal endoscope, on day 1 and repeated on day 14.
Arms:
Beclomethasone
Placebo
Placebo (0.9% sodium chloride) administered topically on an intranasal microsponge, placed in the olfactory cleft using a nasal endoscope, on day 1 and repeated on day 14.
Arms:
Placebo
Microsponge
Drug delivery using chitosan-based biocompatible microsponge
Arms:
Beclomethasone, Placebo
Size
20
Primary endpoint
Change in olfactory function as measured by the Smell Identification Test (SIT)
Baseline, 6 weeks, 18 weeks
Eligibility criteria
Inclusion Criteria:
* Post-COVID hyposmia lasting greater than 3 months following COVID19 by history
* Male or female, aged 18 years or older
Exclusion Criteria:
* 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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2024-03-21
1 organization
1 product
1 indication
Organization
Duke UniversityProduct
Beclomethasone