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| Name | Class |
|---|---|
| Vitrobio | INDUSTRY |
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The goal of this clinical study is to perform a post-market clinical follow-up of 2 medical devices (liquid bandage in the form of a spray : ALLERSPRAY G (product A - code AAG), PCNS (product B - code PC) indicated for symptomatic treatment of allergic rhinitis. This follow-up will consist in collecting real-life clinical data to confirm the safety and efficacy of medical devices used in the treatment of allergic rhinitis of adults patients while allowing an assessment of the product's risk/benefit ratio.
The main questions it aims to answer are:
No comparison group will be constituated because of the type of study (post market follow up) and no comparison between device A and B will be done.
58 participants (29 for medical device A and 29 for medical device B) with allergic rhinitis will be asked to :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment using medical device A | Experimental | Treatment using medical device A (ALLERSPRAY G), it's a topically applied liquid filmogen bandage (in the form of a hypertonic slightly viscous liquid solution) for the treatment of ALLERGIC RHINITIS OF VARIOUS ORIGINS. |
|
| Treatment using medical device B | Experimental | Treatment using medical device B (PCNS), it's a topically applied liquid filmogen bandage (in the form of a hypertonic slightly viscous liquid solution) for the treatment of ALLERGIC RHINITIS OF VARIOUS ORIGINS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLERSPRAY-G (device A) | Device | Symptomatic treatment consists of 3 sprays of medical device A in each nostril while breathing in slightly. This process should be repeated 4 times a day for 14 days by patients participating in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Recording of all adverse events on an electronic journal | From visit 1 (day 1) to the end of treatment at day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Total nasal symptom score (TNSS) | 4 symptoms (stuffy nose, runny nose, sneezing, itching nose) will be evaluated (from 0 "no embarassement" to 10 "extremely embarrassed") by the patient every day during the treatment period (from day 1 to day 14). the 4 symptoms composed the total nasal symptom score (TNSS). Basal and the mean last 3 days of treatment TNSS score of will be compared. | basal and twice a day from visit 1 (day 1) to the end of treatment at day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | France |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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2 indépendants parallel groups (Product A and B) treating a common pathology.
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| PCNS (device B) | Device | Symptomatic treatment consists of 3 sprays of medical device B in each nostril while breathing in slightly. This process should be repeated 4 times a day for 14 days by patients participating in the study. |
|
| Impact of allergic rhinitis on sleep | Evaluation of how much your allergic rhinitis and associated symptoms interfere/impact on sleep (from 0 (not annoying/not at all impact) and 10 (extremely annoying/very impacted) on a visual analog scale | basal (day 1) and after the study treatment period (day 15) |
| Impact of allergic rhinitis on daily activities | Evaluation of how much your allergic rhinitis and associated symptoms interfere/impact on daily activities (from 0 (not annoying/not at all impact) and 10 (extremely annoying/very impacted) on a visual analog scale | basal (day 1) and after the study treatment period (day 15) |
| Impact of allergic rhinitis on fatigue | Evaluation of how much your allergic rhinitis and associated symptoms interfere/impact on fatigue (from 0 (not annoying/not at all impact) and 10 (extremely annoying/very impacted) on a visual analog scale | basal (day 1) and after the study treatment period (day 15) |
| Impact of allergic rhinitis on irritability | Evaluation of how much your allergic rhinitis and associated symptoms interfere/impact on irritability (from 0 (not annoying/not at all impact) and 10 (extremely annoying/very impacted) on a visual analog scale | basal (day 1) and after the study treatment period (day 15) |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |