CompletedPhase 2

Directed Topical Drug Delivery for Treatment for PASC Hyposmia

United States16 participantsStarted 2023-09-05

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Percentage of Participants Achieving MCID (Minimal Clinically Important Difference) on the Smell Identification Test (SIT)

Timeframe: Baseline, 1 month, 3 months

Trial details

NCT IDNCT05970731

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-07

Results submitted2025-09-22

View on ClinicalTrials.gov More Post Acute Sequelae Covid-19 Hyposmia trials