Allergic Rhinitis
Conditions
Brief summary
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.
Interventions
DEVICENasal Spray
3 sprays in each nostril 3 times per day
Sponsors
MediAxe CRO
P & B Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized, double-blind, placebo-controlled study With a 4-7 days run-in period before a 14 days treatment/placebo period
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women ≥ 18 years old 2. Inform consent 3. Beneficiaries of a social security scheme 4. Having documented persistent or intermittent allergic rhinitis for at least 2 years 5. In the respiratory environment allergen battery, at least one prick-test positive at selection (diameter \>3mm compared to the negative control), or prick-test or specific IgE assay less than 6 months old demonstrating an allergic response appropriate 6. Agreeing not to take anti-allergic drug treatment during the duration of the study except in case of aggravation of the disease 7. Having a smartphone or a computer allowing access to the application of seizure To be eligible to be randomized, participants must have: 8. Used the nasal spray at least 2 times a day during the run-in, according to their answers on the application 9. A median VAS for the evaluation of the discomfort due to the symptoms of the selection at D-1 ≥ 50mm Non-inclusion Criteria: 1. Existence of links with any member of the study staff or the sponsor, or conflicts interests with the promoter 2. Known hypersensitivity or allergy to one of the components of the product tested 3. Contraindication to the use of a nasal spray 4. Respiratory pathology other than allergic rhinitis/rhino-conjunctivitis and asthma mild or moderate. People with severe asthma may be included if their asthma is controlled 5. Current treatment with systemic corticosteroids 6. Known pregnancy or positive urine pregnancy test at screening and/or at D0, or breastfeeding in progress 7. Participation in a clinical trial or other clinical investigation using a device medicine for the treatment or prevention of rhinitis or conjunctivitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of patients with a change of at least 23 mm VAS (Visual Analogue Scale) at D4 | 14 days | minimum 0 and maximum 100 (higher scores mean a worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentage of patients who used antihistamines | 14 days | — |
| percentage of change on D4 and D14 compared to D0 of symptoms (nasal obstruction, sneezing, rhinorrhea, sore throat) | 14 days | — |
| percentage of change on D4 and D14 compared to D0 of eye symptoms (itching, tearing, redness) | 14 days | — |
| VAS from D0 to D14 | 14 days | minimum 0 and maximum 100 (higher scores mean a worse outcome) |
| Proportion of premature discontinuations of the study or discontinuations of the product under study | 14 days | — |
| percentage of patients without symptoms at D4 and D14 | 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 | 14 days | — |
| Proportion of participants - satisfied or very satisfied - judging the use easy or very easy | 14 days | — |
| Allergic rhinitis control test on D0 and D14 | 14 days | — |
Countries
France
Outcome results
None listed