Evaluation of Treatments for Allergic Rhinitis (Rhinal 2)

NCT ID: NCT06810947

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2025-04-22

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ALLERSPRAY-G (device A)

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

PCNS (device B)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vitrobio

INDUSTRY

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

RBHP 2024 PICKERING

Identifier Type: -

Identifier Source: org_study_id