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Smell Training + Budesonide for Loss of Smell

Phase 1 & 2
Waitlist Available
Led By Amanda L Stapleton, MD
Research Sponsored by Amanda Stapleton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects ages 6 to 21 who have loss of smell (anosmia) or dysosmia (disordered smell perception) and thought to have occurred due to COVID-19.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months after initial consult appointment
Awards & highlights

Study Summary

This trial will help researchers learn more about how to help people who have lost their sense of smell due to COVID-19.

Who is the study for?
This trial is for children and young adults aged 6 to 21 who have lost their sense of smell due to COVID-19. Participants must be able to report their condition, take a smell test, and follow daily therapy routines. It's not open to those with certain conditions like cystic fibrosis or previous treatments for smell loss.Check my eligibility
What is being tested?
The study is testing the effectiveness of smell retraining therapy alone versus in combination with budesonide-saline nasal irrigations in restoring the sense of smell after COVID-19 infection among pediatric patients.See study design
What are the potential side effects?
Potential side effects may include irritation or discomfort from the nasal irrigation process and possible reactions to budesonide such as dry or sore throat, coughing, and nosebleeds.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 6 and 21 years old and have lost my sense of smell or it has changed, likely because of COVID-19.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months after initial consult appointment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months after initial consult appointment 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 University of Pennsylvania Smell Identification Test (UPSIT) Score From Baseline to First Follow-up
Secondary outcome measures
Change in Loss of Smell Question Score From Baseline to First Follow-up
Change in Sino-nasal Outcome Test-22 (SNOT-22) Score From Baseline to 12 Month Follow-up
Change in Sino-nasal Outcome Test-22 (SNOT-22) Score From Baseline to 6 Month Follow-up
+3 more
Other outcome measures
Change in Anxiety Question Score From Baseline to First Follow-up
Change in Loss of Taste Question Score From Baseline to First Follow-up

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Smell Retraining + BudesonideExperimental Treatment2 Interventions
Participants will undergo smell retraining as described above. They will also complete budesonide irrigations once a day by pouring 0.5mg/2ml of budesonide into a irrigation bottle with saline and irrigating the nose.
Group II: Smell Retraining OnlyActive Control1 Intervention
Participants will undergo smell retraining for 8 weeks. Each week, participants will choose 4 scents. They will smell each item for 15 seconds very close to the nose once a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budesonide
FDA approved

Find a Location

Who is running the clinical trial?

Amanda StapletonLead Sponsor
Amanda L Stapleton, MDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Smell Retraining Clinical Trial Eligibility Overview. Trial Name: NCT04964414 — Phase 1 & 2
Loss of Smell Research Study Groups: Smell Retraining + Budesonide, Smell Retraining Only
Loss of Smell Clinical Trial 2023: Smell Retraining Highlights & Side Effects. Trial Name: NCT04964414 — Phase 1 & 2
Smell Retraining 2023 Treatment Timeline for Medical Study. Trial Name: NCT04964414 — Phase 1 & 2
Loss of Smell Patient Testimony for trial: Trial Name: NCT04964414 — Phase 1 & 2

Frequently Asked Questions

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

Are people of all ages eligible for this clinical trial?

"Researchers are looking for participants who were born between 1999 and 2006."

Answered by AI

What are the screening procedures for this test?

"The ideal participant for this clinical trial is a child or young adult aged 6-21 who currently suffers from anosmia. Additionally, it is imperative that potential subjects are able to take the UPSIT smell test, self-report any changes in their sense of smell, and commit to the assigned daily therapy."

Answered by AI

For what purpose is Smell Retraining therapy most often used?

"Smell Retraining is a conventional medical intervention used to treat acute coryza. However, it can also be used in less common cases such as when patients suffer from proteinuria or Crohn disease."

Answered by AI

How many people have been invited to participate in this research project?

"The latest information from clinicaltrials.gov suggests that this research study is still looking for participants. The 60 patients will be recruited from a single site, and the trial was first posted on September 30th, 2021."

Answered by AI

Could you share some other studies that have used Smell Retraining?

"At present, there are 32 separate studies being conducted on smell retraining. 10 of those studies are in phase 3 clinical trials. Most of the trials for smell retraining are taking place in Xi'an, Shaanxi, but there are 992 locations around the world where these trials are being run."

Answered by AI

Can patients still enroll in this experiment?

"Yes, the information available on clinicaltrials.gov verifies that this trial is still recruiting patients. This particular study was opened on September 30th, 2021 and was last updated October 5th, 2022. The research team is looking for 60 participants total from 1 location."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
New Mexico
Other
Texas
How old are they?
65+
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
2
What site did they apply to?
UPMC Children's Hospital of Pittsburgh

Why did patients apply to this trial?

I'm a chef who has only been able to smell 3-4 times in the last 18 months, and only for 1 minute increments.
PatientReceived 2+ prior treatments
I lost my sense of smell at the end of having Covid in May. It went completely. I went on steroids and it came back, but within days of finishing my course of steroids it went away again. It differs day to day - sometimes I can faintly smell my coffee, others not at all. I had a hypersensitive sense of smell before and I hate not being able to smell.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Recent research and studies
clinicaltrials.govStudy
Treatment of Pediatric Patients That Lost Sense of Smell Due to COVID-19
Amanda Stapleton 2021. "Treatment of Pediatric Patients That Lost Sense of Smell Due to COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04964414.
~6 spots leftby Apr 2025
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