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Corticosteroid

Nasal Spray Therapy for Loss of Smell after COVID-19

Phase 2

Recruiting

Led By Bradley Goldstein, MD, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 18 weeks

Awards & highlights

Study Summary

This trial tests a nasal spray to see if it can help with smell.

Who is the study for?

Adults over 18 who've lost their sense of smell for more than 3 months after COVID-19 can join. Not for pregnant or breastfeeding individuals, those with allergies to the trial's drugs or shellfish, glaucoma patients, people with recent feverish illness, active nasal diseases, or anyone treated with another experimental drug recently.Check my eligibility

What is being tested?

The study tests if a nasal spray containing beclomethasone is better than a placebo at restoring smell in post-COVID cases. Participants are randomly assigned to receive either the real drug or a dummy treatment without knowing which one they're getting.See study design

What are the potential side effects?

Beclomethasone may cause nosebleeds, sore throat, headache, sneezing and coughing. Rarely it might lead to more serious effects like vision problems or increased risk of infections due to immune system suppression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 18 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, 18 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 18 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: BeclomethasoneActive Control2 Interventions

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

Group II: PlaceboPlacebo Group2 Interventions

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,364 Previous Clinical Trials

3,420,622 Total Patients Enrolled

Bradley Goldstein, MD, PhDPrincipal InvestigatorDuke Health

Media Library

Beclomethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05970731 — Phase 2

Post-Covid Hyposmia Research Study Groups: Beclomethasone, Placebo

Post-Covid Hyposmia Clinical Trial 2023: Beclomethasone Highlights & Side Effects. Trial Name: NCT05970731 — Phase 2

Beclomethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05970731 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any spaces available to join this clinical trial?

"The clinicaltrial.gov website reports that this medical study is not looking for new enrollees at present. Initially posted on August 1st 2023, it hasn't been updated since July 24th of the same year. However, there are 707 other trials which currently require participants to join their investigations."

Answered by AI