NCT07383493

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Feb 2026Mar 2027

First Submitted

Initial submission to the registry

January 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

January 26, 2026

Last Update Submit

January 26, 2026

Conditions

Rhinitis AcuteRhinitis ViralRhinosinusitis AcuteRhinopharyngitisRhinitisRhinosinusitis

Outcome Measures

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.

    From visit 1 (day 1) to visit 2 (day 15)

Secondary Outcomes (3)

  • Efficiency

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

  • Quality of life impact

    From visite 1 (day 1) to visit 2 (day 15)

  • Device defect

    From visit 1 (day 1) to visit 2 (day 15)

Study Arms (4)

PIR

EXPERIMENTAL

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

Device: PIR

NS

EXPERIMENTAL

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

Device: NS

NHE

EXPERIMENTAL

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

Device: NHE

NHG

EXPERIMENTAL

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

Device: NHG

Interventions

PIRDEVICE

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

PIR
NSDEVICE

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

NS
NHEDEVICE

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

NHE
NHGDEVICE

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

NHG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • Benefiting from legal protection measures (guardianship, trusteeship, deprivation of liberty, judicial protection).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Common ColdNasopharyngitisRhinitisRhinosinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPharyngitisNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesNose DiseasesSinusitisParanasal Sinus Diseases

Study Officials

  • Lise Laclautre

    University Hospital, Clermont-Ferrand

    STUDY CHAIR

Central Study Contacts

Lise Laclautre

CONTACT

+33473754963promo_interne_drci@chu-clermontferrand.fr

Lise Laclautre

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 3, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations

FR(1)