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Recruiting
NCT07383493
RhinAV_Evaluation of Treatments for Acute Viral Rhinitis, Rhinosinusitis, and Rhinopharyngitis
Conditions: Rhinitis Acute, Rhinitis Viral, Rhinosinusitis Acute, Rhinopharyngitis, Rhinitis, Rhinosinusitis
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: University Hospital, Clermont-Ferrand
Location: Plateforme d'investigation clinique/Centre d'Investigation Clinique, Inserm CIC 1405 Clermont-Ferrand
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 Criteria
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 (\
Source: ClinicalTrials.gov (NCT07383493). StuddyBuddy aggregates publicly available trial information.