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: * Primary objective : Evaluate in real life the tolerance of medical device A and B used in the treatment of allergic rhinitis. * Secondary objectives : Evaluate the efficacy of medical device A and B on allergic rhinitis and the quality of life using the device A and B. 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 : * use medical device A or B during 2 weeks (from inclusion visit to end of study visit), * complete each day at home a diary (recording intensity of 4 nasal symptoms, adverse events, concomitant treatments), * complete " Quality of life evaluation (sleep, daily activities, fatigue, irritability) " at inclusion visit and end of study visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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.
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.
CHU Clermont-Ferrand
Clermont-Ferrand, France
Adverse events
Recording of all adverse events on an electronic journal
Time frame: From visit 1 (day 1) to the end of treatment at day 14
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.
Time frame: basal and twice a day from visit 1 (day 1) to the end of treatment at day 14
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: basal (day 1) and after the study treatment period (day 15)
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