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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
150
Patients included in the "PIR" arm will receive the medical device of the same name.
Patients included in the "NS" arm will receive the medical device of the same name.
Patients included in the "NHE" arm will receive the medical device of the same name.
Patients included in the "NHG" arm will receive the medical device of the same name.
Plateforme d'investigation clinique/Centre d'Investigation Clinique, Inserm CIC 1405
Clermont-Ferrand, France
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)
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)
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)
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)
Lise Laclautre
CONTACT
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