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

University Hospital, Clermont-Ferrand

Status: Not yet enrolling

Conditions: Rhinosinusitis Acute; Rhinosinusitis; Rhinitis; Rhinitis Viral; Rhinitis Acute; Rhinopharyngitis

Treatments: Device: NHE; Device: NS; Device: NHG; Device: PIR

Study type: Interventional

Funder types: Other

Identifiers

NCT07383493

RBHP 2025 PICKERING 4

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 4 patient groups

PIR

Experimental group

Description:

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

Treatment:

Device: PIR

NS

Experimental group

Description:

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

Treatment:

Device: NS

NHE

Experimental group

Description:

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

Treatment:

Device: NHE

NHG

Experimental group

Description:

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

Treatment:

Device: NHG