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RecruitingNCT07383493RhinAVUpdated Jun 15, 2026

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

An interventional study of PIR and NS in Rhinitis Acute, Rhinitis Viral and Rhinosinusitis Acute, sponsored by University Hospital, Clermont-Ferrand. Recruiting at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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, rhinosinusitis, and rhinopharyngitis, while also assessing the benefit/risk ratio of the products.

02

Conditions studied

  • Rhinitis Acute
  • Rhinitis Viral
  • Rhinosinusitis Acute
  • Rhinopharyngitis
  • Rhinitis
  • Rhinosinusitis
03

In context

Common Cold

219 studies on the registry are indexed under Common Cold; 23 are open to participants now.

This study's planned enrollment of 150 is close to the median of 150 across 184 interventional studies indexed under Common Cold.

Browse Common Cold studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion Criteria:

  • /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, , 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 (, asthma, etc.),
  • (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).
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    PIR

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

    Device: PIR

  • Experimental
    NS

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

    Device: NS

  • Experimental
    NHE

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

    Device: NHE

  • Experimental
    NHG

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

    Device: NHG

Interventions

  • DevicePIR

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

  • DeviceNS

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

  • DeviceNHE

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

  • DeviceNHG

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

06

What researchers measure

Primary outcomes

  1. Tolerance

    Collection of adverse events (AEs) during the period of use of PIR, NS, NHE, and NHG products in an electronic daily recording book.

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

Secondary outcomes

  1. 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).

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

  2. 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.

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

  3. 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.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07383493
Responsible party
Sponsor
First posted
Feb 3, 2026
Start date
Feb 25, 2026
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Jun 15, 2026

Study contacts

Lise Laclautre
Contact
promo_interne_drci@chu-clermontferrand.fr
+33473754963
Lise Laclautre
Contact
Lise Laclautre
study chair · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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