Directed Topical Drug Delivery for Treatment for PASC Hyposmia

Duke University16 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Post Acute Sequelae Covid-19 Hyposmia

Interventions

BeclomethasoneDRUG

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.

PlaceboOTHER

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.

MicrospongeDEVICE

Drug delivery using chitosan-based biocompatible microsponge

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Change in olfactory function as measured by the Smell Identification Test (SIT)

The SIT has a score range of 0 to 40, where a higher score reflects better olfactory function.

Time frame: Baseline, 6 weeks, 18 weeks

Secondary Outcomes

Change in olfactory quality of life (QOL) measured by the Questionnaire on Olfactory Disorders (QOD)

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.

Time frame: Baseline, 6 weeks, 18 weeks

Data from ClinicalTrials.gov

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