Clinical trial NCT06810947: Evaluation of Treatments for Allergic Rhinitis (Rhinal 2)
Official title: Evaluation of Treatments for Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Keywords: post-market
clinical study
follow up
allergic rhinitis
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Vitrobio
First posted: 2025-02-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 indépendants parallel groups (Product A and B) treating a common pathology.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Adverse events
timeFrame: From visit 1 (day 1) to the end of treatment at day 14
Secondary outcomes:
measure: Total nasal symptom score (TNSS)
timeFrame: basal and twice a day from visit 1 (day 1) to the end of treatment at day 14
measure: Impact of allergic rhinitis on sleep
timeFrame: basal (day 1) and after the study treatment period (day 15)
measure: Impact of allergic rhinitis on daily activities
timeFrame: basal (day 1) and after the study treatment period (day 15)
measure: Impact of allergic rhinitis on fatigue
timeFrame: basal (day 1) and after the study treatment period (day 15)
measure: Impact of allergic rhinitis on irritability
timeFrame: basal (day 1) and after the study treatment period (day 15)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
References: