Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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?
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steroid nasal drops combined with olfactory training | Combination Product | The intervention consists of two components: steroid nasal drops and modified olfactory training. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire of Olfactory Disorders - Negative Statements (QOD-NS) | The QOD-NS includes 17 negative statements, each graded from 0 (disagree) to 3 (agree) for a maximum score of 51. Higher QOD-NS scores reflect worse QoL. | Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dawei Wu, MD, PhD | Contact | 13522503401 | davidwuorl@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dawei Wu | Beijing | Beijing Municipality | 100191 | China |
We will decide whether to share the individual participant data after the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo nasal drops combined with olfactory training | Combination Product | The intervention consists of two components: normal saline nasal drops and modified olfactory training. |
|
| Olfactory-Visual Analogue Scale (VAS) |
Subjects rate the impact of smell loss on their mood, ability to enjoy food, social interactions, safety, personal hygiene, sex life, ability to cook food, appetite and change in weight from 0 (no impact) to 10 (most impact) for a maximum score of 90. Higher olfactory-VAS scores reflect more severe impacts on daily life. |
| Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment. |
| CT Evaluation of Olfactory Cleft Blockage | The olfactory cleft was divided into anterior and posterior, divided by the anterior end of the superior turbinate. The anterior and posterior olfactory cleft opacifications were graded separately on a scale of 0-4 by the ratio of the opacified area to the whole area of the olfactory cleft, with 0 (no opacification), 1 (25%), 2 (25%-50%), 3 (50%-75%), and 4 (>75%). The olfactory cleft CT score, calculated as the sum of the anterior and posterior olfactory cleft scores, ranged from 1 to 8 (Kim DW, Kim JY, Jeon SY. The status of the olfactory cleft may predict postoperative olfactory function in chronic rhinosinusitis with nasal polyposis. Am J Rhinol Allergy. 2011;25(2):e90-4.). | Baseline and 12 weeks after the initiation of treatment. |
| Inflammatory Marker Levels in Olfactory Mucosa | Analysis of inflammatory cytokines (IL-4、IL-5、IL-13、IL-25、IL-33 and TSLP)via ELISA and single-cell sequencing from olfactory mucosal brush samples. | Baseline and 12 weeks after the initiation of treatment. |
| Plasma Cortisol Levels | Measurement of systemic cortisol concentrations through venous blood sampling | Baseline and 12 weeks after the initiation of treatment. |
| Adverse Event | Documentation of local (nasal irritation, epistaxis) and systemic steroid-related adverse events using standardized case report forms during all follow-up visits. | 2 weeks, and 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment. |
| ID | Term |
|---|---|
| D000857 | Olfaction Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000094562 | Olfactory Training |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided