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

P & B Group

Status: Completed

Conditions: Allergic Rhinitis

Treatments: Device: Nasal Spray

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05443945

IC2-2111.11NS

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 2 patient groups, including a placebo group

Advanced Water -100 ionized nasal spray

Experimental group

Description:

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

Treatment:

Device: Nasal Spray

Nasal spray with purified water

Placebo Comparator group

Description:

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

Treatment:

Device: Nasal Spray