Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis
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: Interleukin-4 receptor responders, Placebo.
- Кому может быть актуально
- Состояния в реестре: Seasonal Allergic Rhinitis. 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Efficacy and Safety of Humanized Antibody Targeting the Interleukin-4 Receptor Alpha Subunit (IL-4Rα) in Patients With Uncontrolled Seasonal Allergic Rhinitis Under Standard Treatment： A Randomized, Double-Blind, Placebo-controlled IIT Study
Обзор
Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.
Подробное описание
AR is a common clinical chronic nasal disease, affecting 10% to 20% of the world's population, and has become a global health problem. AR not only seriously affects the quality of life of patients, resulting in patient fatigue, impaired learning, attention, and decision-making ability, but also causes a heavy social burden.
AR has a variety of classification methods. According to the type of allergen, it can be divided into seasonal (SAR, common allergens are seasonal allergens such as pollen) and perennial (PAR, common allergens are indoor allergens such as dust mites or occupational allergies), which is a classification method often used in clinical studies. According to the course of the disease, it can be divided into intermittent (symptom onset \< 4 days/week, or \< 4 consecutive weeks) and persistent (symptom onset ≥ 4 days/week, and ≥ 4 consecutive weeks). According to the severity of the disease, it can be divided into minor AR (mild symptoms, with no significant impact on quality of life) and moderate-severe AR (more severe or severe symptoms, with significant impact on quality of life). The results of the cooperative survey showed that persistent moderate-to-severe disease was the most common in the overall population, accounting for 52.2%, indicating that the treatment and control of AR has become an urgent problem to be solved.
Вмешательства
- Биопрепарат Interleukin-4 receptor responders
Interleukin-4 receptor was injected subcutaneously. - Другое Placebo
Placebo was injected subcutaneously.
Первичные конечные точки
- Average change from baseline in daily retrospective total nasal symptom score (rTNSS) at week 2. [Срок оценки: up to Week 2]
Критерии участия
Критерии включения
- Voluntarily sign the informed consent form.
Критерии исключения
- Have any condition that are not suitable for participating in this study.
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
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Beijing Tongren Hospital, Capital Medical University — Пекин
Идентификаторы
NCT: NCT06300203 · CM310_IIS_SAR07