Rhinitis AcuteRhinAVNCT07383493
RhinAV_Evaluation of Treatments for Acute Viral Rhinitis, Rhinosinusitis, and Rhinopharyngitis
A study testing PIR, NS and NHE in people with Rhinitis Acute and Rhinitis Viral, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rhinitis Acute, Rhinitis Viral, Rhinosinusitis Acute
- What is being tested?
- PIR, NS and NHE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2026to Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lise Laclautre contact
France1 site, 1 recruiting
- Recruiting
Plateforme d'investigation clinique/Centre d'Investigation Clinique, Inserm CIC 1405
Clermont-Ferrand
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
promo_interne_drci@chu-clermontferrand.fr
About this study
Official title: 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.
- Conditions
- Rhinitis Acute, Rhinitis Viral, Rhinosinusitis Acute, Rhinopharyngitis, Rhinitis, Rhinosinusitis
- Being tested
- PIR, NS, NHE, NHG
- Medical subject headings
- Common Cold, Nasopharyngitis, Rhinitis, Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIRDevice
Patients included in the "PIR" arm will receive the medical device of the same name.
NSDevice
Patients included in the "NS" arm will receive the medical device of the same name.
NHEDevice
Patients included in the "NHE" arm will receive the medical device of the same name.
NHGDevice
Patients included in the "NHG" arm will receive the medical device of the same name.
| Study group | Role | What they receive |
|---|---|---|
| PIR | Experimental | Patients included in the "PIR" arm will receive the medical device of the same name. Receives: Device: PIR |
| NS | Experimental | Patients included in the "NS" arm will receive the medical device of the same name. Receives: Device: NS |
| NHE | Experimental | Patients included in the "NHE" arm will receive the medical device of the same name. Receives: Device: NHE |
| NHG | Experimental | Patients included in the "NHG" arm will receive the medical device of the same name. Receives: Device: NHG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance
Collection of adverse events (AEs) during the period of use of PIR, NS, NHE, and NHG products in an electronic daily recording book.
Measured: From visit 1 (day 1) to visit 2 (day 15)
Secondary outcomes (3)
Efficiency
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).
Measured: From visit 1 (day 1) to the last day of use of the study product (day 14)
Quality of life impact
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.
Measured: From visite 1 (day 1) to visit 2 (day 15)
Device defect
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.
Measured: From visit 1 (day 1) to visit 2 (day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start25 Feb 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lise Laclautre, Study chair, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383493
- Sponsor's protocol ID
- RBHP 2025 PICKERING 4
- Acronym
- RhinAV
- Status last verified
- Jun 2026
- First submitted
- 26 Jan 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No