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Идёт набор NCT05494346

Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"

Без фазы С лечением Acute Rhinitis Nasal Obstruction Rhinosinusitis Rhinopharyngitis

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: Measurement of peak nasal flow..
Кому может быть актуально
Состояния в реестре: Acute Rhinitis, Nasal Obstruction, Rhinosinusitis, Rhinopharyngitis. Базовые параметры: от 12 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
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Официальное название

Prospective Multicenter Clinical Investigation Evaluating the Performance and Safety of Gilbert Laboratories' Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils

Обзор

The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.

Вмешательства

  • Устройство Measurement of peak nasal flow.
    Peak nasal flow measurements will be performed before and after the first use of the spray at D0, as well as after the use of the spray at the medical office at D3 (only for arm A).

Первичные конечные точки

  • Performance of the Gilbert Laboratories pocket valve spray. [Срок оценки: From Day 0 to Day 3]
Вторичные конечные точки (12)
  • Change of nasal obstruction between Day 0 and Day 3 [Срок оценки: From Day 0 to Day 3]
  • Immediate change of nasale obstruction at D0 on first use (Arm A) [Срок оценки: At Day 0]
  • Subjective feeling of reduced nasal obstruction on each day of use (arms A+B). [Срок оценки: From Day 0 to Day 6]
  • Subjective feeling of nasal cavity cleansing (freshness) each day of use (arms A+B). [Срок оценки: From Day 0 to Day 6]
  • Subjective feeling of nasal secretion thinning on each day of use (arms A+B). [Срок оценки: From Day 0 to Day 6]
  • Subjective feeling of relief of nasal irritation (mucous membrane) on each day of use (arms A+B). [Срок оценки: From Day 0 to Day 6]
  • Subjective feeling of relief of nasal itching on each day of use (arms A+B). [Срок оценки: From Day 0 to Day 6]
  • Speed of action at which the patient feels (subjectively) a decrease in nasal obstruction at D0 and D3 (arms A+B). [Срок оценки: At Day 0 and Day 3]
  • Speed of action at which the patient feels (subjectively) a purification of his nasal cavities (sensation of freshness) at D0 and D3 (arms A+B). [Срок оценки: At Day 0 and Day 3]
  • Improvement in the patient's quality of life after 7 days of use (arms A+B). [Срок оценки: From Day 0 to Day 6]
  • Patient satisfaction with the medical device after 7 days of use (arm A+B). [Срок оценки: At Day 6]
  • Facility of use of the medical device after 7 days of use (arm A+B) [Срок оценки: At Day 6]

Критерии участия

Критерии включения

  • 1\. Patient ≥ 12 years.
  • 2\. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhinopharyngitis (cold), rhinosinusitis, or during non-infectious episodes such as allergic rhinitis.
  • 3\. a. Informed adult patient who has given written consent prior to any study specific procedure. b. Informed minor patient who has given assent and whose legal guardians have given written consent prior to any study-specific procedure.
  • 4\. Patient able to meet the study requirements for monitoring, spray use, and questionnaire completion.
  • 5\. Patient affiliated to a social security scheme.

Критерии исключения

  • 1\. Pregnant and/or breastfeeding woman
  • 2\. Hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray.
  • 3\. Diseases causing narrowing of the airways (e.g. asthma, chronic obstructive pulmonary disease (COPD)) and/or respiratory insufficiency.
  • 4\. Patients with uncontrolled asthma (GINA score greater than or equal to 4)
  • 5\. Patients undergoing allergy desensitization
  • 6\. Patients suffering from chronic nasal obstruction due to a deformation of the nasal wall or nasal polyps. creams or gels.
  • 7\. Patients taking local and systemic vasoconstrictors, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotics, and local antiseptics.
  • 8\. Concomitant use of other nasal sprays, essential oils for local nasal use, creams, or gels for the nose.
  • 9\. Patients under guardianship, conservatorship, or legal protection.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Франция · 5 центров
  • Cabinet Médical — Blainville-sur-Orne
  • Cabinet Médical Caen — Caen
  • MSP du Haut Anjou — Châteauneuf-sur-Sarthe
  • Cabinet Médical Gainneville — Gainneville
  • ALYATEC — Strasbourg

Идентификаторы

NCT: NCT05494346 · 2021-A01898-33

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗