What side effects are associated with this type of intervention?

Smell Retraining Therapy, which involves repeated exposure to various odors to stimulate the olfactory system, is generally considered safe with minimal side effects, though some individuals may experience temporary discomfort or irritation from strong smells. Budesonide-Saline Irrigations, a corticosteroid treatment used to reduce nasal inflammation, can have side effects such as nasal irritation, dryness, and, in rare cases, nosebleeds. Long-term use of corticosteroids may also carry a risk of systemic effects like adrenal suppression, though this is uncommon with nasal administration.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for treatments directly targeting loss of smell, particularly those involving smell retraining therapy or budesonide-saline irrigations. Smell retraining therapy, which involves repeated exposure to various odors to stimulate the olfactory system, is a non-pharmacological approach and thus does not require FDA approval. Budesonide, a corticosteroid used to reduce nasal inflammation, is FDA-approved for conditions like chronic rhinosinusitis, which can indirectly help with olfactory function. However, its specific use in saline irrigations for treating loss of smell due to COVID-19 or other causes is still under investigation.

What other types of research exist?

Promising novel alternatives for treating loss of smell in 2024 may include: 1) Intranasal insulin therapy, which has shown potential in enhancing olfactory function by promoting neuronal growth and repair. 2) Platelet-rich plasma (PRP) therapy, which involves injecting concentrated platelets to stimulate tissue regeneration and repair. 3) Olfactory training combined with virtual reality (VR) to create immersive environments that enhance the effectiveness of traditional smell retraining. 4) Gene therapy targeting specific olfactory receptor genes to restore function in cases of genetic olfactory loss. These alternatives are still under investigation but offer hope for more effective treatments.

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Smell Training + Budesonide for Loss of Smell

Q: What is the mechanism of action of this treatment?

Smell Retraining Therapy involves repeated exposure to specific odors to stimulate and potentially regenerate the olfactory system, which can help improve the sense of smell over time. This method leverages the brain's plasticity to enhance olfactory function. Budesonide-Saline Irrigations use a corticosteroid to reduce nasal inflammation, which can clear nasal passages and improve airflow, thereby enhancing the effectiveness of smell retraining. These treatments are crucial for patients with loss of smell as they address both the neurological and inflammatory components of olfactory dysfunction, offering a comprehensive approach to rehabilitation.

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

Must not have

Duration of anosmia or dysosmia <60 days

Previous smell retraining

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 6 months after initial consult appointment

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests if smell retraining therapy and budesonide-saline nasal rinses can help children and young adults regain their sense of smell after losing it due to COVID-19. Smell retraining involves smelling different scents regularly, while budesonide-saline rinses aim to reduce nasal inflammation. The study aims to see if combining these treatments is more effective than smell retraining alone. Budesonide has been widely studied and used in various nasal treatments, including for allergic rhinitis and chronic rhinosinusitis.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a loss or change in my sense of smell for less than 60 days.

Select...

I have undergone smell training before.

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I have had a brain tumor in the past.

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I have multiple sclerosis.

Select...

I have a seizure disorder.

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I have cystic fibrosis.

Select...

I have been diagnosed with Primary Ciliary Dyskinesia.

Select...

I have had nasal polyps in the past.

Select...

I cannot report my own health status.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6 months after initial consult appointment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in University of Pennsylvania Smell Identification Test (UPSIT) Score From Baseline to First Follow-up

Secondary study objectives

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 study objectives

Change in Anxiety Question Score From Baseline to First Follow-up

Change in Loss of Taste Question Score From Baseline to First Follow-up

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Smell Retraining Therapy involves repeated exposure to specific odors to stimulate and potentially regenerate the olfactory system, which can help improve the sense of smell over time. This method leverages the brain's plasticity to enhance olfactory function. Budesonide-Saline Irrigations use a corticosteroid to reduce nasal inflammation, which can clear nasal passages and improve airflow, thereby enhancing the effectiveness of smell retraining. These treatments are crucial for patients with loss of smell as they address both the neurological and inflammatory components of olfactory dysfunction, offering a comprehensive approach to rehabilitation.

Applying nasal airflow - inducing maneuvers with patients with hyposmia after total laryngectomy.