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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIR | Experimental | Patients included in the "PIR" arm will receive the medical device of the same name. |
|
| NS | Experimental | Patients included in the "NS" arm will receive the medical device of the same name. |
|
| NHE | Experimental | Patients included in the "NHE" arm will receive the medical device of the same name. |
|
| NHG | Experimental | Patients included in the "NHG" arm will receive the medical device of the same name. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIR | Device | Patients included in the "PIR" arm will receive the medical device of the same name. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance | Collection of adverse events (AEs) during the period of use of PIR, NS, NHE, and NHG products in an electronic daily recording book. | From visit 1 (day 1) to visit 2 (day 15) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From visit 1 (day 1) to the last day of use of the study product (day 14) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | +33473754963 | promo_interne_drci@chu-clermontferrand.fr | |
| Lise Laclautre | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Lise Laclautre | University Hospital, Clermont-Ferrand | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plateforme d'investigation clinique/Centre d'Investigation Clinique, Inserm CIC 1405 | Recruiting | Clermont-Ferrand | France |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| D009304 | Nasopharyngitis |
| D012220 | Rhinitis |
| D000096825 | Rhinosinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| NS |
| Device |
Patients included in the "NS" arm will receive the medical device of the same name. |
|
| NHE | Device | Patients included in the "NHE" arm will receive the medical device of the same name. |
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| NHG | Device | Patients included in the "NHG" arm will receive the medical device of the same name. |
|
| 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. | 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. | From visit 1 (day 1) to visit 2 (day 15) |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D010612 | Pharyngitis |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009668 | Nose Diseases |
| D012852 | Sinusitis |
| D010254 | Paranasal Sinus Diseases |