RhinAV_Evaluation of Treatments for Acute Viral Rhinitis, Rhinosinusitis, and Rhinopharyngitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
PIR
DevicePatients included in the "PIR" arm will receive the medical device of the same name.
NS
DevicePatients included in the "NS" arm will receive the medical device of the same name.
NHE
DevicePatients included in the "NHE" arm will receive the medical device of the same name.
NHG
DevicePatients included in the "NHG" arm will receive the medical device of the same name.
Treatment groups
150 Participants
are divided into 4 treatment groupsGroup A: PIRExperimental treatment 1 intervention
Group B: NSExperimental treatment 1 intervention
Group C: NHEExperimental treatment 1 intervention
Group D: NHGExperimental treatment 1 intervention
Trial outcomes
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)Sponsors and contacts
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Source ClinicalTrials.gov