This is a phase II randomized, double-blinded, placebo-controlled study to evaluate theefficacy of topical intranasal treatment of beclomethasone vs. placebo for improvedolfactory function.
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 visits: 2 visits for drug administration at Baseline and
Week 2, and 2 follow-up visits at Week 6 and Week 18. Participants will be expected to
complete the Smell Identification Test (SIT) and Questionnaire on Olfactory Disorders
(QOD) at baseline, Week 6, and Week 18. The investigator hypothesizes that the
application of beclomethasone directly in the nasal cavity will result in improved
olfactory function.
Drug: 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.
Other: 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.
Device: Microsponge
Drug delivery using chitosan-based biocompatible microsponge
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)
Duke University Medical Center
Durham 4464368, North Carolina 4482348, United States
Bradley Goldstein, MD, PhD, Principal Investigator
Duke Health