Directed Topical Drug Delivery for Treatment for PASC Hyposmia

Duke University

Status and phase: Completed; Phase 2

Conditions: Post Acute Sequelae Covid-19 Hyposmia

Treatments: Drug: Beclomethasone; Other: Placebo; Device: Microsponge

Study type: Interventional

Funder types: Other

Identifiers

NCT05970731

Pro00113299

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

Beclomethasone

Active Comparator group

Description:

84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14)

Treatment:

Device: Microsponge

Drug: Beclomethasone

Placebo

Placebo Comparator group

Description:

Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14)

Treatment:

Device: Microsponge

Other: Placebo