Evaluation of Treatments for Allergic Rhinitis (Rhinal 2) (RHINAL 2)

Evaluation of Treatments for Allergic Rhinitis

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 Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Device: ALLERSPRAY-G (device A); Device: PCNS (device B)

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment using medical device A; 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.	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.
Experimental: Treatment using medical device B; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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)

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Vitrobio

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Actual): April 22, 2025
• Study Completion (Actual): April 22, 2025

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: allergic rhinitis; clinical study; follow up; post-market
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: RBHP 2024 PICKERING

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No