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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beclomethasone | Active Comparator | 84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14) |
|
| Placebo | Placebo Comparator | Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving MCID (Minimal Clinically Important Difference) on the Smell Identification Test (SIT) | 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. | Baseline, 1 month, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Olfactory Quality of Life (QOL) Measured by the Questionnaire on Olfactory Disorders (QOD) | 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. | Baseline, 1 month, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley Goldstein, MD, PhD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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One participant was found to be ineligible prior to arm assignment.
Participants were recruited from an academic center otolaryngology clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Beclomethasone | 84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14) 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. Microsponge: Drug delivery using chitosan-based biocompatible microsponge |
| FG001 | Placebo | Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14) 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. Microsponge: Drug delivery using chitosan-based biocompatible microsponge |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Beclomethasone | 84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14) 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. Microsponge: Drug delivery using chitosan-based biocompatible microsponge |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving MCID (Minimal Clinically Important Difference) on the Smell Identification Test (SIT) | 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. | Participants with data collected at both timepoints used for analysis. | Posted | Number | percentage of participants | Baseline, 1 month, 3 months |
|
Up to approximately 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Beclomethasone | 84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14) 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. Microsponge: Drug delivery using chitosan-based biocompatible microsponge |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bradley J. Goldstein, M.D., Ph.D. | Duke University | 919-684-3834 | bradley.goldstein@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2023 | Sep 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000086582 | Anosmia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| 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 |
|
| BG001 |
| Placebo |
Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14) 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. Microsponge: Drug delivery using chitosan-based biocompatible microsponge |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| Placebo |
Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14) 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. Microsponge: Drug delivery using chitosan-based biocompatible microsponge |
|
|
|
| Secondary | Change in Olfactory Quality of Life (QOL) Measured by the Questionnaire on Olfactory Disorders (QOD) | 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. | Participants with data collected at both timepoints used for analysis. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 1 month, 3 months |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Placebo | Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14) 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. Microsponge: Drug delivery using chitosan-based biocompatible microsponge | 0 | 8 | 0 | 8 | 0 | 8 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000857 | Olfaction Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |