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Recruiting

NCT Number: NCT07383493

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

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Plateforme d'investigation clinique/Centre d'Investigation Clinique, Inserm CIC 1405

Clermont-Ferrand, France

Location status: Recruiting

Location contact

Gisèle PICKERING

PRINCIPAL_INVESTIGATOR

Lise Laclautre

CONTACT

[email protected]

+33473754963

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PIR

Device

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

NS

Device

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

NHE

Device

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

NHG

Device

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

Primary outcomes

  1. Tolerance

    Time frame: 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.

Secondary outcomes

  1. Efficiency

    Time frame: From visit 1 (day 1) to the last day of use of the study product (day 14)

    Clinical improvement (yes/no) defined as a decrease of at least 30% in the "total score for symptoms of rhinitis, rhinosinusitis, and rhinopharyngitis" (STS3R) between baseline and the average of the scores measured during the last 3 days of use of the study product (days 12, 13, and 14).

  2. Quality of life impact

    Time frame: From visite 1 (day 1) to visit 2 (day 15)

    Change in quality of life measured by four questions before (Day 1) and after (Day 15) use of the study products concerning sleep, daily activities, fatigue, and irritability. Each response will be rated between 0 (not impacted) and 10 (highly impacted) on a visual analog scale.

  3. Device defect

    Time frame: From visit 1 (day 1) to visit 2 (day 15)

    Device defect assessed by recording any defect in terms of identity, quality, durability, reliability, safety, or performance, malfunction, or user error, or any defect in the information provided by the manufacturer in the electronic record book.

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

+33473754963

Lise Laclautre

CONTACT

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: RhinAV

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 3, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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