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

University Hospital, Clermont-Ferrand

Status and phase: Not yet enrolling; Phase 4

Conditions: Allergic Rhinitis

Treatments: Device: PCNS (device B); Device: ALLERSPRAY-G (device A)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06810947

RBHP 2024 PICKERING

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Treatment using medical device A

Experimental group

Description:

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:

Device: ALLERSPRAY-G (device A)

Treatment using medical device B

Experimental group

Description:

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.

Treatment:

Device: PCNS (device B)