Allergic Rhinitis
Conditions
Keywords
post-market, clinical study, follow up, allergic rhinitis
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.
Interventions
DEVICEALLERSPRAY-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.
DEVICEPCNS (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
Vitrobio
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2 indépendants parallel groups (Product A and B) treating a common pathology.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | From visit 1 (day 1) to the end of treatment at day 14 | Recording of all adverse events on an electronic journal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total nasal symptom score (TNSS) | basal and twice a day from visit 1 (day 1) to the end of treatment at day 14 | 4 symptoms (stuffy nose, runny nose, sneezing, itching nose) will be evaluated (from 0 no embarassement to 10 extremely embarrassed) by the patient every day during the treatment period (from day 1 to day 14). the 4 symptoms composed the total nasal symptom score (TNSS). Basal and the mean last 3 days of treatment TNSS score of will be compared. |
| Impact of allergic rhinitis on sleep | basal (day 1) and after the study treatment period (day 15) | Evaluation of how much your allergic rhinitis and associated symptoms interfere/impact on sleep (from 0 (not annoying/not at all impact) and 10 (extremely annoying/very impacted) on a visual analog scale |
| Impact of allergic rhinitis on daily activities | basal (day 1) and after the study treatment period (day 15) | Evaluation of how much your allergic rhinitis and associated symptoms interfere/impact on daily activities (from 0 (not annoying/not at all impact) and 10 (extremely annoying/very impacted) on a visual analog scale |
| Impact of allergic rhinitis on fatigue | basal (day 1) and after the study treatment period (day 15) | Evaluation of how much your allergic rhinitis and associated symptoms interfere/impact on fatigue (from 0 (not annoying/not at all impact) and 10 (extremely annoying/very impacted) on a visual analog scale |
| Impact of allergic rhinitis on irritability | basal (day 1) and after the study treatment period (day 15) | Evaluation of how much your allergic rhinitis and associated symptoms interfere/impact on irritability (from 0 (not annoying/not at all impact) and 10 (extremely annoying/very impacted) on a visual analog scale |
Countries
France
Outcome results
None listed