Directed Topical Drug Delivery for Treatment for PASC Hyposmia

Phase 2

Completed

• Conditions: Post Acute Sequelae Covid-19 Hyposmia
• Interventions: Drug: Beclomethasone; Other: Placebo; Device: Microsponge

• Registration Number: NCT05970731
• Lead Sponsor: Duke University

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 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.

Study Timeline

• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-08-01
• Study Start: 2023-09-05
• Status Verified: 2024-06
• Primary Completion: 2024-10-07
• Study Completion: 2024-10-07
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beclomethasone	Beclomethasone	84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14)
Beclomethasone	Microsponge	84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14)
Placebo	Placebo	Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14)
Placebo	Microsponge	Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14)

Primary Outcome Measures

Name	Time	Method
Change in olfactory function as measured by the Smell Identification Test (SIT)	Baseline, 6 weeks, 18 weeks	The SIT has a score range of 0 to 40, where a higher score reflects better olfactory function.

Secondary Outcome Measures

Name	Time	Method
Change in olfactory quality of life (QOL) measured by the Questionnaire on Olfactory Disorders (QOD)	Baseline, 6 weeks, 18 weeks	The QOD consists of 17 statements which patients report on a scale of 0 to 3. These scores are summed for a total score range of 0 to 51, where a higher score reflects better olfactory-specific QOL.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States