Post-marketing follow-up of four devices for acute viral rhinitis and related conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This post-marketing study collects real-world clinical data on four medical devices used to treat acute viral rhinitis, rhinosinusitis, and rhinopharyngitis. It aims to confirm tolerability, safety, and efficacy while evaluating the benefit/risk balance in typical clinical settings. Eligible participants are adults and networked patients who meet the criteria and consent to data collection. The trial is conducted at a clinical investigation platform in Clermont-Ferrand, France, under the SI-RIPH VRB registration and French Social Security affiliation.

Why it matters

Who can join: the full rules

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).

Where it's running

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

Study contacts

• Study coordinator: Lise Laclautre
• Email: promo_interne_drci@chu-clermontferrand.fr
• Phone: +33473754963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.