Набор скоро начнётся NCT07620522

Observational Study of RHINOSEDAL in Acute Nasal Obstruction

— Наблюдательное Nasal Obstruction Common Cold Allergic Rhinitis Non-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: RHINOSEDAL.
Кому может быть актуально: Состояния в реестре: Nasal Obstruction, Common Cold, Allergic Rhinitis, Non-allergic Rhinitis. Базовые параметры: от 8 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: Франция
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

Prospective Multicenter Before-After Study in Children and Adults Treated for Acute Nasal Obstruction With RHINOSEDAL

Обзор

This prospective, multicenter, national, observational, non-interventional post-market clinical follow-up study evaluates the performance and safety of RHINOSEDAL in children and adults presenting with acute nasal obstruction associated with common cold, allergic or non-allergic rhinitis, or rhinosinusitis. Patients prescribed RHINOSEDAL in routine care will be followed for 6 ±1 days using patient-reported outcome measures including the NOSE score.

Подробное описание

RHINOSEDAL is a CE-marked class IIa medical device indicated in adults and children older than 2 years to relieve nasal congestion through an osmotic mechanism in cases of common cold, allergic or non-allergic rhinitis, and sinusitis. This prospective observational study is conducted in real-life conditions of use in French general practice. The decision to prescribe RHINOSEDAL is made before and independently from study participation. Patients aged 8 years and older with acute nasal obstruction evolving for less than 48 hours and baseline NOSE score \>40/100 will be included. Patients will complete a self-assessment diary from Day 1 to Day 6 ±1. The primary endpoint is the proportion of patients achieving a decrease greater than 24 mm in the NOSE score between baseline Day 0 and the Day 3 evening assessment. Secondary endpoints include additional NOSE responder analyses, daily NOSE evolution, individual NOSE item evolution, social activity impairment, patient global assessment of effectiveness, associated signs, safety, device deficiencies, and compliance.

Вмешательства

Устройство RHINOSEDAL
RHINOSEDAL is a ready-to-use hypertonic nasal spray containing natural sea water, tamarind extract and mallow extract. It acts mechanically through osmotic decongestion and cleansing of the upper airways. It is used according to the instructions for use and physician prescription.

Первичные конечные точки

NOSE responder rate at Day 3 [Срок оценки: Day 3 evening]

Вторичные конечные точки (8)

NOSE responder rate at Day 6 or end of study [Срок оценки: Day 6 ±1 day or early termination]
Daily evolution of total NOSE score [Срок оценки: Day 0 to Day 6 ±1 day or early termination]
Daily evolution of each NOSE questionnaire item [Срок оценки: Day 0 to Day 6 ±1 day or early termination]
Daily evolution of social activity impairment [Срок оценки: Day 0 to Day 6 ±1 day or early termination]
Patient global assessment of effectiveness [Срок оценки: End of study visit at Day 6 ±1 day or early termination]
Evolution of associated signs [Срок оценки: Day 0 to Day 6 ±1 day or early termination]
Adverse events, serious adverse events, incidents and device deficiencies [Срок оценки: Inclusion to Day 6 ±1 day or early termination]
Compliance / RHINOSEDAL use [Срок оценки: Day 0 to Day 6 ±1 day or early termination]

Критерии участия

Критерии включения

Age 8 years or older.
Acute nasal obstruction evolving for less than 48 hours associated with common cold, allergic or non-allergic rhinitis, or rhinosinusitis.
Baseline NOSE score >40/100.
No warning signs such as pus, unilateral obstruction, bleeding, or pain.
RHINOSEDAL prescribed by the investigator.
Written informed consent signed.
Affiliated with a health insurance system.