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Набор скоро начнётся NCT07386860

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

Без фазы С лечением Smell Dysfunction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Steroid nasal drops combined with olfactory training, Placebo nasal drops combined with olfactory training.
Кому может быть актуально
Состояния в реестре: Smell Dysfunction. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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?

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Dawei Wu — Пекин

Идентификаторы

NCT: NCT07386860 · 9059106

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗