Evaluation of Treatments for Allergic Rhinitis (Rhinal 2)

NCT06810947 | Completed Phase 4

• 1 other identifier: RBHP 2024 PICKERING
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Keywords

post-market; clinical study; follow up; allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total nasal symptom score (TNSS)

  basal and twice a day from visit 1 (day 1) to the end of treatment at day 14

• Impact of allergic rhinitis on sleep

  basal (day 1) and after the study treatment period (day 15)

• Impact of allergic rhinitis on daily activities

  basal (day 1) and after the study treatment period (day 15)

• Impact of allergic rhinitis on fatigue

  basal (day 1) and after the study treatment period (day 15)

• Impact of allergic rhinitis on irritability

  basal (day 1) and after the study treatment period (day 15)

Study Arms (2)

Treatment using medical device A

EXPERIMENTAL

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)

Treatment using medical device B

EXPERIMENTAL

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)

Interventions

ALLERSPRAY-G (device A) 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 A

PCNS (device B) 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.

Treatment using medical device B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• " 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,

You may not qualify if:

• Known hypersensitivity to any of the components of the evaluated products,
• Use of any treatment to treat allergic rhinitis,
• pregnant or breastfeeding women,
• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Vitrobio: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 indépendants parallel groups (Product A and B) treating a common pathology.

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: March 3, 2025
• Primary Completion: April 22, 2025
• Study Completion: April 22, 2025
• Last Updated: June 13, 2025

Record last verified: 2024-12

Locations

FR (1)