Directed Topical Drug Delivery for Treatment for PASC Hyposmia

NCT05970731 | Completed Phase 2 Results FDA Drug FDA Device

• 1 other identifier: Pro00113299
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Acute Sequelae Covid-19 Hyposmia

Keywords

Covid-19; smell loss; hyposmia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving MCID (Minimal Clinically Important Difference) on the Smell Identification Test (SIT)

  The SIT has a score range of 0 to 40, where a higher score reflects better olfactory function. MCID is defined at a 4 point increase.

  Baseline, 1 month, 3 months

Secondary Outcomes (1)

• Change in Olfactory Quality of Life (QOL) Measured by the Questionnaire on Olfactory Disorders (QOD)

  Baseline, 1 month, 3 months

Study Arms (2)

Beclomethasone

ACTIVE COMPARATOR

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

Drug: Beclomethasone; Device: Microsponge

Placebo

PLACEBO COMPARATOR

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

Other: Placebo; Device: Microsponge

Interventions

Beclomethasone DRUG

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.

Beclomethasone

Placebo OTHER

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.

Placebo

Microsponge DEVICE

Drug delivery using chitosan-based biocompatible microsponge

Beclomethasone; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-COVID hyposmia lasting greater than 3 months following COVID19 by history
• Male or female, aged 18 years or older

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

COVID-19; Anosmia

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Results Point of Contact

• Title: Bradley J. Goldstein, M.D., Ph.D.
• Organization: Duke University

bradley.goldstein@duke.edu

919-684-3834

Study Officials

• Bradley Goldstein, MD, PhD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: September 5, 2023
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: March 19, 2026
• Results First Posted: March 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)