Evaluation of Treatments for Allergic Rhinitis (Rhinal 2)

Phase 4

Completed

• Conditions: Allergic Rhinitis

• Registration Number: NCT06810947
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Study First Posted: 2025-02-06
• Study Start: 2025-03-03
• Primary Completion: 2025-04-22
• Study Completion: 2025-04-22
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• " Score For Allergic Rhinitis " ≥ 8
• Age ≥ 18
• Able to refrain from using any treatment for allergic rhinitis or any other treatment that could interfere with the purpose of the study,
• Effective contraception for women of reproductive age,
• Cooperation and understanding sufficient to comply with the requirements of the study,
• Acceptance to give written consent and inscription to VRB french platform for the duration of the study,
• Affiliation to the French Social Security system,

Exclusion Criteria

• Known hypersensitivity to any of the components of the evaluated products,
• Use of any treatment to treat allergic rhinitis,
• pregnant or breastfeeding women,
• participating in another clinical trial, or being in the exclusion period, or having received a total amount of benefits exceeding EUR 6000 over the 12 months preceding the start of the trial,
• benefiting from a measure of legal protection (guardianship, deprivation of liberty, safeguard of justice),
• having a medical and / or surgical history judged by the investigator or his representative to be incompatible with the test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adverse events	From visit 1 (day 1) to the end of treatment at day 14	Recording of all adverse events on an electronic journal

Secondary Outcome Measures

Name	Time	Method
Total nasal symptom score (TNSS)	basal and twice a day from visit 1 (day 1) to the end of treatment at day 14	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.
Impact of allergic rhinitis on sleep	basal (day 1) and after the study treatment period (day 15)	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
Impact of allergic rhinitis on daily activities	basal (day 1) and after the study treatment period (day 15)	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
Impact of allergic rhinitis on fatigue	basal (day 1) and after the study treatment period (day 15)	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
Impact of allergic rhinitis on irritability	basal (day 1) and after the study treatment period (day 15)	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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France