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| Name | Class |
|---|---|
| MediAxe CRO | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced Water -100 ionized nasal spray | Experimental | 3 sprays in each nostril, 3 times a day during 14 days |
|
| Nasal spray with purified water | Placebo Comparator | 3 sprays in each nostril, 3 times a day during 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Spray | Device | 3 sprays in each nostril 3 times per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Men and women ≥ 18 years old
Inform consent
Beneficiaries of a social security scheme
Having documented persistent or intermittent allergic rhinitis for at least 2 years
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
Agreeing not to take anti-allergic drug treatment during the duration of the study except in case of aggravation of the disease
Having a smartphone or a computer allowing access to the application of seizure
To be eligible to be randomized, participants must have:
Used the nasal spray at least 2 times a day during the run-in, according to their answers on the application
A median VAS for the evaluation of the discomfort due to the symptoms of the selection at D-1 ≥ 50mm
Non-inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sébastien Lefevre, Dr | CHR Metz-Thionville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GHEF | Jossigny | Seine Et Marne | 77600 | France | ||
| CH Aix Maupertuis |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Randomized, double-blind, placebo-controlled study
With a 4-7 days run-in period before a 14 days treatment/placebo period
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| VAS from D0 to D14 | minimum 0 and maximum 100 (higher scores mean a worse outcome) | 14 days |
| Allergic rhinitis control test on D0 and D14 | 14 days |
| percentage of patients without symptoms at D4 and D14 | 14 days |
| percentage of patients who used antihistamines | 14 days |
| Proportion of premature discontinuations of the study or discontinuations of the product under study | 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 |
| Aix-en-Provence |
| 13100 |
| France |
| CHR Metz-Thionville | Ars-Laquenexy | 57530 | France |
| Cabinet Libéral | Lille | 59000 | France |
| Hôpital Saint Vincent | Lille | 59000 | France |
| Cabinet libéral | Manosque | 04100 | France |
| Hôpital Nord - APHM | Marseille | 13015 | France |
| CHU Montpellier | Montpellier | 34000 | France |
| Centre d'allergologie de Gentilly | Nancy | 54000 | France |
| Cabinet Libéral | Paris | 75014 | France |
| Alyatec | Strasbourg | 67000 | France |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |