RhinAV_Evaluation of Treatments for Acute Viral Rhinitis, Rhinosinusitis, and Rhinopharyngitis

Официальное название

Evaluation of Treatments for Acute Viral Rhinitis, Rhinosinusitis, and Rhinopharyngitis

Обзор

The objective of this study is to conduct post-marketing clinical follow-up of four products: NS, NHE, NHG, and PIR. This follow-up will consist of collecting clinical data in real-life conditions to confirm the tolerance, safety, and efficacy of medical devices used in the treatment of acute viral rhinitis, rhinosinusitis, and rhinopharyngitis, while also assessing the benefit/risk ratio of the products.

Вмешательства

• Устройство PIR
  Patients included in the "PIR" arm will receive the medical device of the same name.
• Устройство NS
  Patients included in the "NS" arm will receive the medical device of the same name.
• Устройство NHE
  Patients included in the "NHE" arm will receive the medical device of the same name.
• Устройство NHG
  Patients included in the "NHG" arm will receive the medical device of the same name.

Первичные конечные точки

• Tolerance [Срок оценки: From visit 1 (day 1) to visit 2 (day 15)]

Вторичные конечные точки (3)

• Efficiency [Срок оценки: From visit 1 (day 1) to the last day of use of the study product (day 14)]
• Quality of life impact [Срок оценки: From visite 1 (day 1) to visit 2 (day 15)]
• Device defect [Срок оценки: From visit 1 (day 1) to visit 2 (day 15)]

Критерии участия

Критерии включения

• Acute viral rhinitis or acute rhinosinusitis or viral rhinopharyngitis (sneezing, rhinorrhea, nasal obstruction, cough secondary to posterior rhinorrhea, sore throat) that began less than 72 hours prior to the inclusion visit, in the investigator's judgment,
• Effective contraception for female patients of childbearing age.
• Cooperation and sufficient understanding to comply with the requirements of the trial.
• Acceptance of registration in the SI-RIPH VRB file.
• Having received informed information and agreeing to give written consent.
• Affiliated with the French Social Security system.

Критерии исключения

• Hypersensitivity/history of allergy to any of the product's components,
• Complicated rhinitis, rhinosinusitis, or rhinopharyngitis (acute bacterial sinusitis, acute otitis media, acute bronchitis, or pneumonia) or severe cough that is poorly tolerated,
• Chronic rhinosinusitis,
• Allergic rhinosinusitis,
• Other ongoing treatments for acute rhinitis (local treatment, antitussives, antibiotics, antiretrovirals, corticosteroids, etc.),
• Positive antigen test for influenza A/B or COVID-19 and infection requiring etiological treatment according to the recommendations,
• Bacterial rhinopharyngitis with positive TROD test
• Comorbidities or health conditions deemed incompatible with the trial by the investigator,
• Recent ENT surgery (<6 months),
• ENT pathology such as nasal septum deviation or other causes of nasal obstruction,
• Pulmonary pathology (COPD, asthma, etc.),
• Immunosuppression (as reported by the patient),
• Pregnant or breastfeeding women,
• Currently participating in another clinical trial, or in the exclusion period, or having received total compensation of more than €6,000 in the 12 months prior to the start of the trial,
• Benefiting from legal protection measures (guardianship, trusteeship, deprivation of liberty, judicial protection).

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

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Plateforme d'investigation clinique/Centre d'Investigation Clinique, Inserm CIC 1405 — Clermont-Ferrand

Идентификаторы

NCT: NCT07383493 · RBHP 2025 PICKERING 4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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