The Effectiveness of Steroid Nasal Drops in the Olfactory Cleft Combined With Olfactory Training for Patients With PIOD

NCT07386860 | Not Yet Recruiting DMC

• 1 other identifier: 9059106
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of hormone nasal drops in the olfactory cleft combined with olfactory training for treating postinfectious olfactory dysfunction (PIOD). The main questions this clinical trial seeks to answer are: Can the combination of hormone nasal drops and olfactory training improve smell function better than olfactory training alone in PIOD patients? How does this combined treatment work?

Conditions

Smell Dysfunction

Keywords

post-infectious olfactory dysfunction; olfactory training; steroid drops; combined therapy

Outcome Measures

Primary Outcomes (1)

• The Sniffin' Sticks test

  A clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification(TDI)

  Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.

Secondary Outcomes (6)

• Questionnaire of Olfactory Disorders - Negative Statements (QOD-NS)

  Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.

• Olfactory-Visual Analogue Scale (VAS)

  Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.

• CT Evaluation of Olfactory Cleft Blockage

  Baseline and 12 weeks after the initiation of treatment.

• Inflammatory Marker Levels in Olfactory Mucosa

  Baseline and 12 weeks after the initiation of treatment.

• Plasma Cortisol Levels

  Baseline and 12 weeks after the initiation of treatment.

Study Arms (2)

Hormone Nasal Drops Combined with Olfactory Training Group

EXPERIMENTAL

Olfactory Cleft Steroid Nasal Drops: Patients will be instructed to assume the Mygind position. Five drops of budesonide suspension (2ml:1mg) will be instilled into each nostril to facilitate delivery to the olfactory cleft. This position will be maintained for 5 minutes, after which patients should expectorate any residual medication. The treatment regimen will follow a tapered schedule: twice daily during the first treatment month, reduced to once daily in the second month, and further reduced to every other day in the third month. Olfactory Training: Participants will perform olfactory training using a modified training device programmed with four distinct odorants (rose, peppermint, tea tree, and clove). Each odorant will be sniffed for 10 seconds per nostril, with 10-second intervals between odorants. Each training session lasts 5 minutes and is conducted twice daily, before breakfast and at bedtime, for a duration of 3 months.

Combination Product: Steroid nasal drops combined with olfactory training

Placebo Nasal Drops Combined with Olfactory Training Group

PLACEBO COMPARATOR

The placebo group will receive normal saline nasal drops, with all other procedures identical to those in the intervention group.

Combination Product: Placebo nasal drops combined with olfactory training

Interventions

Steroid nasal drops combined with olfactory training COMBINATION_PRODUCT

The intervention consists of two components: steroid nasal drops and modified olfactory training.

Hormone Nasal Drops Combined with Olfactory Training Group

Placebo nasal drops combined with olfactory training COMBINATION_PRODUCT

The intervention consists of two components: normal saline nasal drops and modified olfactory training.

Placebo Nasal Drops Combined with Olfactory Training Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prospective enrollment of otolaryngology clinic patients aged 18-65 years with olfactory dysfunction. Diagnosis of post-infectious olfactory dysfunction (PIOD) will be based on the PPOD 2023 criteria. Participants must demonstrate olfactory impairment via Sniffin' Sticks testing, with TDI scores (sum of Threshold, Discrimination, and Identification) meeting: (1) Hyposmia: 16 \< TDI \< 30.75; (2) Anosmia: TDI ≤ 15.
• Willingness to participate and signed informed consent.

You may not qualify if:

• Use of systemic corticosteroids within 4 weeks or intranasal steroids within 2 weeks prior to enrollment.
• Severe nasal septum deviation, nasal tumors, acute upper respiratory infections, or uncontrolled allergic rhinitis.
• History of functional endoscopic sinus surgery or other nasal procedures within 12 months.
• Severe cardiovascular disease, hepatic/renal insufficiency, uncontrolled diabetes, or immune system disorders.
• Current or planned pregnancy.
• Investigator-determined inability to comply with study requirements (e.g., memory/behavioral disorders, depression, heavy alcohol use, prior non-compliance).

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Dawei Wu

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Olfaction Disorders

Interventions

Olfactory Training

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Dawei Wu, MD, PhD

CONTACT

13522503401; davidwuorl@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 4, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)