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Recruiting Not applicable

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

NCT07383493 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-02-25
Last updated
2026-06-15

Condition(s) studied

Rhinitis AcuteRhinitis ViralRhinosinusitis AcuteRhinopharyngitisRhinitisRhinosinusitis

Investigational drug(s) / intervention(s)

PIRNSNHENHG

PIR: Patients included in the "PIR" arm will receive the medical device of the same name.

NS: Patients included in the "NS" arm will receive the medical device of the same name.

NHE: Patients included in the "NHE" arm will receive the medical device of the same name.

NHG: Patients included in the "NHG" arm will receive the medical device of the same name.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Primary outcome measure(s)

  • Tolerance — From visit 1 (day 1) to visit 2 (day 15)
    Collection of adverse events (AEs) during the period of use of PIR, NS, NHE, and NHG products in an electronic daily recording book.

Trial sites (1)

FacilityCityRegionStatus
Plateforme d'investigation clinique/Centre d'Investigation Clinique, Inserm CIC 1405 Clermont-Ferrand France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07383493 on ClinicalTrials.gov ↗ ← All trials in France