Directed Topical Drug Delivery for Treatment for PASC Hyposmia

Purpose

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.

Condition

  • Post Acute Sequelae Covid-19 Hyposmia

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Beclomethasone 		84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14)
  • 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.
  • Device: Microsponge
    Drug delivery using chitosan-based biocompatible microsponge
Placebo Comparator
Placebo 		Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and 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

Recruiting Locations

Duke University Medical Center
Durham, North Carolina 27710
Contact:
Bradley Goldstein, MD, PhD
919-684-6595
bradley.goldstein@duke.edu

More Details

NCT ID
NCT05970731
Status
Recruiting
Sponsor
Duke University

Study Contact

Revital Benvenisti
919-668-5328
revital.benvenisti@duke.edu

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.