Directed Topical Drug Delivery for Treatment for PASC Hyposmia

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: Recruiting
• Conditions: Post Acute Sequelae Covid-19 Hyposmia
• Intervention / Treatment: Drug: Beclomethasone; Device: Microsponge; Other: Placebo

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 (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Eliza Sorrell; Phone Number: +1 919 684 6484; Email: eliza.sorrell@duke.edu
• Study Contact Backup: Name: Amy Walker; Phone Number: +1 919 684 1732; Email: amy.walker1@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
      • Contact: Bradley Goldstein, MD, PhD; Phone Number: 919-684-6595; Email: bradley.goldstein@duke.edu

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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
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.	Baseline, 6 weeks, 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 6 weeks, 18 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Bradley Goldstein, MD, PhD, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 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 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Covid-19; hyposmia; smell loss
• Additional Relevant MeSH Terms: Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurologic Manifestations; Sensation Disorders; Olfaction Disorders; COVID-19; Anosmia; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Beclomethasone
• 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