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Completed

NCT Number: NCT05970731

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.

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Key information

Conditions

Post Acute Sequelae Covid-19 Hyposmia Anosmia COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nervous System Diseases Neurologic Manifestations Nidovirales Infections Olfaction Disorders Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sensation Disorders Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Microsponge

Device

Drug delivery using chitosan-based biocompatible microsponge

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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