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
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Sniffin' Sticks test
概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •Willingness to participate and signed informed consent.
排除标准
- •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).
研究组 & 干预措施
Hormone Nasal Drops Combined with Olfactory Training Group
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.
干预措施: Steroid nasal drops combined with olfactory training (Combination Product)
Placebo Nasal Drops Combined with Olfactory Training Group
The placebo group will receive normal saline nasal drops, with all other procedures identical to those in the intervention group.
干预措施: Placebo nasal drops combined with olfactory training (Combination Product)
结局指标
主要结局
The Sniffin' Sticks test
时间窗: Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.
A clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification(TDI)
次要结局
- 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.)
- Adverse Event(2 weeks, and 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.)
研究者
Dawei Wu
Associate Researcher
Peking University Third Hospital