Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing Symptoms of Allergic Rhinitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-30

Study Completion Date

2023-08-14

Brief Summary

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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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Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, placebo-controlled study

With a 4-7 days run-in period before a 14 days treatment/placebo period

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Advanced Water -100 ionized nasal spray

3 sprays in each nostril, 3 times a day during 14 days

Group Type EXPERIMENTAL

Nasal Spray

Intervention Type DEVICE

3 sprays in each nostril 3 times per day

Nasal spray with purified water

3 sprays in each nostril, 3 times a day during 14 days

Group Type PLACEBO_COMPARATOR

Nasal Spray

Intervention Type DEVICE

3 sprays in each nostril 3 times per day

Interventions

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Nasal Spray

3 sprays in each nostril 3 times per day

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No