Trial Outcomes & Findings for Directed Topical Drug Delivery for Treatment for PASC Hyposmia (NCT NCT05970731)
NCT ID: NCT05970731
Last Updated: 2026-03-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Baseline, 1 month, 3 months
Results posted on
2026-03-19
Participant Flow
Participants were recruited from an academic center otolaryngology clinic.
One participant was found to be ineligible prior to arm assignment.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Baseline SIT (Smell Identification Test) High
|
1
|
0
|
|
Overall Study
COVID infection
|
0
|
1
|
Baseline Characteristics
Directed Topical Drug Delivery for Treatment for PASC Hyposmia
Baseline characteristics by cohort
| Measure |
Beclomethasone
n=7 Participants
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
|
Placebo
n=8 Participants
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
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 21.8 • n=110 Participants
|
56.0 years
STANDARD_DEVIATION 17.5 • n=114 Participants
|
54.7 years
STANDARD_DEVIATION 19.6 • n=224 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=110 Participants
|
6 Participants
n=114 Participants
|
10 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=110 Participants
|
2 Participants
n=114 Participants
|
5 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=110 Participants
|
8 Participants
n=114 Participants
|
15 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
2 Participants
n=224 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=110 Participants
|
3 Participants
n=114 Participants
|
7 Participants
n=224 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=110 Participants
|
5 Participants
n=114 Participants
|
6 Participants
n=224 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=110 Participants
|
8 Participants
n=114 Participants
|
15 Participants
n=224 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 month, 3 monthsPopulation: Participants with data collected at both timepoints used for analysis.
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.
Outcome measures
| Measure |
Beclomethasone
n=6 Participants
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
|
Placebo
n=7 Participants
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
|
|---|---|---|
|
Percentage of Participants Achieving MCID (Minimal Clinically Important Difference) on the Smell Identification Test (SIT)
Baseline to 1 month
|
66.70 percentage of participants
|
28.57 percentage of participants
|
|
Percentage of Participants Achieving MCID (Minimal Clinically Important Difference) on the Smell Identification Test (SIT)
Baseline to 3 months
|
66.70 percentage of participants
|
42.86 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 3 monthsPopulation: Participants with data collected at both timepoints used for analysis.
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.
Outcome measures
| Measure |
Beclomethasone
n=6 Participants
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
|
Placebo
n=7 Participants
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
|
|---|---|---|
|
Change in Olfactory Quality of Life (QOL) Measured by the Questionnaire on Olfactory Disorders (QOD)
|
6.17 score on a scale
Interval 1.7 to 14.04
|
2.66 score on a scale
Interval -0.96 to 4.38
|
Adverse Events
Beclomethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place