Evaluation of Treatments for Acute Viral Rhinitis, Rhinosinusitis, and Rhinopharyngitis
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University Hospital, Clermont-Ferrand
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Tolerance
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
Arms & Interventions
PIR
Patients included in the "PIR" arm will receive the medical device of the same name.
Intervention: PIR (Device)
NS
Patients included in the "NS" arm will receive the medical device of the same name.
Intervention: NS (Device)
NHE
Patients included in the "NHE" arm will receive the medical device of the same name.
Intervention: NHE (Device)
NHG
Patients included in the "NHG" arm will receive the medical device of the same name.
Intervention: NHG (Device)
Outcomes
Primary Outcomes
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
- 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))