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Directed Topical Drug Delivery for Treatment for PASC Hyposmia

NCT05970731 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-03-19

Study results available
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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.

Conditions

  • Post Acute Sequelae Covid-19 Hyposmia

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Bradley Goldstein, MD, PhD · Duke Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-05
Primary Completion
2024-10-07
Completion
2024-10-07
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05970731 on ClinicalTrials.gov