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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Tolerance [Time frame: From visit 1 (day 1) to visit 2 (day 15)]

Secondary outcome measures (3)

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

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 (<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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

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

Identifiers

NCT: NCT07383493 · RBHP 2025 PICKERING 4

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗