A nasal spray based on Advanced Water S-100 ionized water would clean the nasal cavities, reduce the viscosity of mucus and facilitate its elimination and decongestion of the nose and the prevention of the bridging of the allergen to the epithelial cells of the cavity nose at the origin of the onset of symptoms. Indeed, a water-based nasal spray ionized Advanced Water S-100 would modify the electrostatic environment of all the interactions ensuring this bridging. Negative ions (OH-) contained in water ionized Advanced Water S-100 competes with negative ions from acids negatively charged amino acids and also neutralize basic amino acids positively charged. The destabilization of all the links governing the process of epitope/IgE association would prevent the bridging of the FcɛRI receptors of the mast cell and thus the cascade of cellular responses that cause symptoms. The purpose of this study is to assess whether the use of ionized water nasal spray ADW S-100 allows to sufficiently reduce the intensity of the symptoms of allergic rhinitis and thus improve the quality of life of people with allergies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
95
3 sprays in each nostril 3 times per day
GHEF
Jossigny, Seine Et Marne, France
CH Aix Maupertuis
Aix-en-Provence, France
CHR Metz-Thionville
Ars-Laquenexy, France
Cabinet Libéral
Lille, France
Hôpital Saint Vincent
Lille, France
Cabinet libéral
Manosque, France
Hôpital Nord - APHM
Marseille, France
CHU Montpellier
Montpellier, France
Centre d'allergologie de Gentilly
Nancy, France
Cabinet Libéral
Paris, France
...and 1 more locations
percentage of patients with a change of at least 23 mm VAS (Visual Analogue Scale) at D4
minimum 0 and maximum 100 (higher scores mean a worse outcome)
Time frame: 14 days
percentage of change on D4 and D14 compared to D0 of symptoms (nasal obstruction, sneezing, rhinorrhea, sore throat)
Time frame: 14 days
percentage of change on D4 and D14 compared to D0 of eye symptoms (itching, tearing, redness)
Time frame: 14 days
VAS from D0 to D14
minimum 0 and maximum 100 (higher scores mean a worse outcome)
Time frame: 14 days
Allergic rhinitis control test on D0 and D14
Time frame: 14 days
percentage of patients without symptoms at D4 and D14
Time frame: 14 days
percentage of patients who used antihistamines
Time frame: 14 days
Proportion of premature discontinuations of the study or discontinuations of the product under study
Time frame: 14 days
Proportion of attendees presenting events adverse events (AE), serious adverse events (SUE), AEs related to the product of the study, AEs of interest particular: respiratory infections
Time frame: 14 days
Proportion of participants - satisfied or very satisfied - judging the use easy or very easy
Time frame: 14 days
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