Plateforme d'investigation clinique/Centre d'Investigation Clinique, Inserm CIC 1405
Clermont-Ferrand, France
Location status: Recruiting
Location contact
Gisèle PICKERING
PRINCIPAL_INVESTIGATOR
Lise Laclautre
CONTACT
CONTACT
NCT Number: NCT07383493
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Clermont-Ferrand, France
Location status: Recruiting
Gisèle PICKERING
PRINCIPAL_INVESTIGATOR
Lise Laclautre
CONTACT
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
University Hospital, Clermont-Ferrand
Other
Evaluation of Treatments for Acute Viral Rhinitis, Rhinosinusitis, and Rhinopharyngitis
Acronym: RhinAV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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