Directed Topical Drug Delivery for Treatment for PASC Hyposmia

February 26, 2026 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Device: Microsponge
Drug delivery using chitosan-based biocompatible microsponge
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving MCID (Minimal Clinically Important Difference) on the Smell Identification Test (SIT)
Time Frame: Baseline, 1 month, 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Olfactory Quality of Life (QOL) Measured by the Questionnaire on Olfactory Disorders (QOD)
Time Frame: Baseline, 1 month, 3 months
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. The change from baseline to 3 months is reported.
Baseline, 1 month, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Bradley Goldstein, MD, PhD, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2023

Primary Completion (Actual)

October 7, 2024

Study Completion (Actual)

October 7, 2024

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00113299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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