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Evaluation of Treatments for Allergic Rhinitis (Rhinal 2)

NCT06810947 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-06-13

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Vitrobio

    collaborator INDUSTRY

  • University Hospital, Clermont-Ferrand

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2025-04-22
Completion
2025-04-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06810947 on ClinicalTrials.gov