RhinAV_Evaluation of Treatments for Acute Viral Rhinitis, Rhinosinusitis, and Rhinopharyngitis (RhinAV)

January 26, 2026 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lise LACLAUTRE

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PIR
Patients included in the "PIR" arm will receive the medical device of the same name.
Device: PIR
Patients included in the "PIR" arm will receive the medical device of the same name.
Experimental: NS
Patients included in the "NS" 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.
Experimental: NHE
Patients included in the "NHE" 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.
Experimental: NHG
Patients included in the "NHG" 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From visit 1 (day 1) to visit 2 (day 15)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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)
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.
From visite 1 (day 1) to visit 2 (day 15)
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.
From visit 1 (day 1) to visit 2 (day 15)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Study Chair: Lise Laclautre, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2025 PICKERING 4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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