Rhinitis Acute, Rhinitis Viral, Rhinosinusitis Acute, Rhinopharyngitis, Rhinitis, Rhinosinusitis
Conditions
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.
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.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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, * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance | 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
| Measure | Time frame | Description |
|---|---|---|
| Efficiency | 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). |
| Quality of life impact | 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. |
| Device defect | 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. |
Countries
France
Contacts
CONTACTLise Laclautre
STUDY_CHAIRLise Laclautre
University Hospital, Clermont-Ferrand
Outcome results
None listed