Adults 6 to 21, any sex, with Dysosmia or Anosmia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in University of Pennsylvania Smell Identification Test (UPSIT) Score From Baseline to First Follow-upPrimary· Before and after 8-12 weeks of smell retraining
Change in University of Pennsylvania Smell Identification Test (UPSIT) score from baseline at the initial consult appointment to the first follow-up appointment at 8 weeks (range 8 to 12 weeks). The UPSIT is a smell identification test and is a 40-item scratch and sniff test with a four-choice multiple choice question on each of the 10 pages in the booklet. Indication of smell loss can be determined - anosmia (total loss) and mild, moderate, or severe microsomia and a detection for malingering. The minimum possible score is a 0 and the maximum is a 40. A higher score indicates better smell/out
Before smell retraining
Group
Value
95% CI
Smell Retraining Only
23.3
± 7.3
Smell Retraining + Budesonide
34
After 8-12 weeks of smell retraining
Group
Value
95% CI
Smell Retraining Only
22.3
± 7.3
Smell Retraining + Budesonide
35
Change in Sino-nasal Outcome Test-22 (SNOT-22) Score From Baseline to First Follow-upSecondary· Before and after 8-12 weeks of smell retraining
Change in Sino-nasal Outcome Test-22 (SNOT-22) score from baseline at the initial consult appointment to the first follow-up appointment at 8 weeks (range 8 to 12 weeks). The SNOT-22 is a 22 question survey that asks about symptoms and social/emotional consequences of a nasal disorder. The survey is on a 6 point scale - No problem (0), very mild problem (1), mild or slight problem (2), moderate problem (3), severe problem (4), and problem as bad as it can be (5). The minimum possible score is 0 and the maximum is 110. A higher score indicates more sino-nasal symptoms/worse outcome.
Before smell retraining
Group
Value
95% CI
Smell Retraining Only
23
10 – 41
Smell Retraining + Budesonide
37
After 8-12 weeks of smell retraining
Group
Value
95% CI
Smell Retraining Only
25
11 – 37
Smell Retraining + Budesonide
39
Change in Loss of Smell Question Score From Baseline to First Follow-upSecondary· Before and after 8-12 weeks of smell retraining
Change in loss of smell on a 0-10 scale from baseline at the initial consult appointment to the first follow-up appointment at 8 weeks (range 8 to 12 weeks). Subjects are asked to rate the symptom severity of loss of smell from 0 (no loss) to 10 (total loss). A higher score indicates worse smell/outcome.
Before smell retraining
Group
Value
95% CI
Smell Retraining Only
6.0
± 3.3
Smell Retraining + Budesonide
6.0
After 8-12 weeks of smell retraining
Group
Value
95% CI
Smell Retraining Only
5.0
± 3.7
Smell Retraining + Budesonide
8.0
Change in University of Pennsylvania Smell Identification Test (UPSIT) Score From Baseline to 6 Month Follow-upSecondary· Baseline and 6 months after initial consult appointment
Change in University of Pennsylvania Smell Identification Test (UPSIT) score from baseline at the initial consult appointment to the 6 month follow-up appointment. The minimum possible score is a 0 and the maximum is a 40. A higher score indicates better smell/outcome.
Before smell retraining
Group
Value
95% CI
Smell Retraining Only
15
13 – 21
After 6 months of smell retraining
Group
Value
95% CI
Smell Retraining Only
17
14 – 24
Change in Sino-nasal Outcome Test-22 (SNOT-22) Score From Baseline to 6 Month Follow-upSecondary· Baseline and 6 months after initial consult appointment
Change in Sino-nasal Outcome Test-22 (SNOT-22) score from baseline at the initial consult appointment to the 6 month follow-up appointment. The minimum possible score is 0 and the maximum is 110. A higher score indicates more sino-nasal symptoms/worse outcome.
Before smell retraining
Group
Value
95% CI
Smell Retraining Only
25
15 – 41
After 6 months of smell retraining
Group
Value
95% CI
Smell Retraining Only
9
8 – 14
Change in Loss of Taste Question Score From Baseline to First Follow-upSecondary· Before and after 8-12 weeks of smell retraining
Change in loss of taste on a 0-10 scale from baseline at the initial consult appointment to the first follow-up appointment at 8 weeks (range 8 to 12 weeks). Subjects are asked to rate the symptom severity of loss of taste from 0 (no loss) to 10 (total loss). A higher score indicates less taste/worse outcome.
Before smell retraining
Group
Value
95% CI
Smell Retraining Only
3.6
± 3.8
Smell Retraining + Budesonide
6.0
After 8-12 weeks of smell retraining
Group
Value
95% CI
Smell Retraining Only
1.6
± 2.1
Smell Retraining + Budesonide
8.0
Change in Anxiety Question Score From Baseline to First Follow-upSecondary· Before and after 8-12 weeks of smell retraining
Change in anxiety on a 0-10 scale from baseline at the initial consult appointment to the first follow-up appointment at 8 weeks (range 8 to 12 weeks). Subjects are asked to rate the symptom severity of anxiety from 0 (no anxiety) to 10 (worst possible anxiety). A higher score indicates more anxiety/worse outcome.
Before smell retraining
Group
Value
95% CI
Smell Retraining Only
5.0
± 4.4
Smell Retraining + Budesonide
7.0
After 8-12 weeks of smell retraining
Group
Value
95% CI
Smell Retraining Only
3.4
± 4.4
Smell Retraining + Budesonide
8.5
Sponsor's own description
This research study is a randomized controlled trial in pediatric and young adult patients who have lost their sense of smell due to COVID-19 viral infection. The goals are:
1. to learn more about the effects of smell retraining therapy on smell loss following COVID-19 and
2. to determine if budesonide-saline irrigations make smell retraining therapy more effective.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amanda Stapleton
Last refreshed: 13 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04964414.