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Not yet recruiting NCT07386860

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

No phase Interventional Smell Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Steroid nasal drops combined with olfactory training, Placebo nasal drops combined with olfactory training.
Who it may be relevant to
Registry conditions: Smell Dysfunction. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Randomized Controlled Study on the Effectiveness of Steroid Nasal Drops in the Olfactory Cleft Combined With Olfactory Training for Patients With Post-infectious Olfactory Dysfunction

Overview

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?

Detailed description

Post-infectious olfactory dysfunction (PIOD) is a prevalent condition, particularly following viral upper respiratory infections such as COVID-19, and significantly impacts patients' quality of life. Current treatments primarily rely on olfactory training, but its effectiveness varies, with improvement rates ranging between 30% and 50%. Emerging evidence suggests that olfactory cleft obstruction and chronic inflammation play critical roles in PIOD pathogenesis, highlighting the potential benefits of targeted steroid therapy to address these underlying mechanisms.

In this study, the investigators planned to recruit 100 patients and divided them into two groups for combined therapy with steroid drops or placebo drops alongside olfactory training, and validate the effectiveness of the combined therapy based on the comparison of the outcomes of the two groups.

Interventions

  • Combination product Steroid nasal drops combined with olfactory training
    The intervention consists of two components: steroid nasal drops and modified olfactory training.
  • Combination product Placebo nasal drops combined with olfactory training
    The intervention consists of two components: normal saline nasal drops and modified olfactory training.

Primary outcome measures

  • The Sniffin' Sticks test [Time frame: Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.]
Secondary outcome measures (6)
  • Questionnaire of Olfactory Disorders - Negative Statements (QOD-NS) [Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.]
  • Olfactory-Visual Analogue Scale (VAS) [Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.]
  • CT Evaluation of Olfactory Cleft Blockage [Time frame: Baseline and 12 weeks after the initiation of treatment.]
  • Inflammatory Marker Levels in Olfactory Mucosa [Time frame: Baseline and 12 weeks after the initiation of treatment.]
  • Plasma Cortisol Levels [Time frame: Baseline and 12 weeks after the initiation of treatment.]
  • Adverse Event [Time frame: 2 weeks, and 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Dawei Wu — Beijing

Identifiers

NCT: NCT07386860 · 9059106

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗