NCT06810947

Evaluation of Treatments for Allergic Rhinitis (Rhinal 2)

Evaluation of Treatments for Allergic Rhinitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DEVICE	ALLERSPRAY-G (device A)	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.
DEVICE	PCNS (device B)	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.

Timeline

• Start date: 2025-03-03
• Primary completion: 2025-04-22
• Completion: 2025-04-22
• First posted: 2025-02-06
• Last updated: 2025-06-13

Locations

1 site across 1 country: France