Directed Topical Drug Delivery for Treatment for PASC Hyposmia
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 12. Participants will be expected to complete the Smell Identification Test (SIT) and Questionnaire on Olfactory Disorders (QOD) at baseline, Week 6, and Week 12. The investigator hypothesizes that the application of beclomethasone directly in the nasal cavity will result in improved olfactory function.
Study Design
Arms and Interventions
| 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) |
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.
Device: Microsponge
Drug delivery using chitosan-based biocompatible microsponge
|
Outcome Measures
Primary Outcome Measures
- Change in olfactory function as measured by the Smell Identification Test (SIT) [Baseline, 6 weeks, 12 weeks]
The SIT has a score range of 0 to 40, where a higher score reflects better olfactory function.
Secondary Outcome Measures
- Change in olfactory quality of life (QOL) measured by the Questionnaire on Olfactory Disorders (QOD) [Baseline, 6 weeks, 12 weeks]
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.
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Duke University
Investigators
- Principal Investigator: Bradley Goldstein, MD, PhD, Duke Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00113299