MedDataX Logo

Directed Topical Drug Delivery for Treatment for PASC Hyposmia

NCT ID: NCT05970731

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-05

Study Completion Date

2024-10-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Acute Sequelae Covid-19 Hyposmia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Beclomethasone

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

Group Type ACTIVE_COMPARATOR

Beclomethasone

Intervention Type 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.

Microsponge

Intervention Type DEVICE

Drug delivery using chitosan-based biocompatible microsponge

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Microsponge

Intervention Type DEVICE

Drug delivery using chitosan-based biocompatible microsponge

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

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.

Intervention Type OTHER

Microsponge

Drug delivery using chitosan-based biocompatible microsponge

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bradley Goldstein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00113299

Identifier Type: -

Identifier Source: org_study_id