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

Allergic Rhinitis Clinical Trial

— SPRA  

Official title:

Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing Symptoms of Allergic Rhinitis: Randomized, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05443945
• Other study ID #: IC2-2111.11NS
• Status: Completed
• Phase: N/A
• Start date: August 30, 2022
• Est. completion date: August 14, 2023

Study information

• Verified date: September 2023
• Source: P & B Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Device:
• Nasal Spray
3 sprays in each nostril 3 times per day

Locations

Country	Name	City	State
France	CH Aix Maupertuis	Aix en Provence
France	CHR Metz-Thionville	Ars-laquenexy
France	GHEF	Jossigny	Seine Et Marne
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	Alyatec	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
P & B Group	MediAxe CRO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	percentage of change on D4 and D14 compared to D0 of symptoms (nasal obstruction, sneezing, rhinorrhea, sore throat)		14 days
Secondary	percentage of change on D4 and D14 compared to D0 of eye symptoms (itching, tearing, redness)		14 days
Secondary	VAS from D0 to D14	minimum 0 and maximum 100 (higher scores mean a worse outcome)	14 days
Secondary	Allergic rhinitis control test on D0 and D14		14 days
Secondary	percentage of patients without symptoms at D4 and D14		14 days
Secondary	percentage of patients who used antihistamines		14 days
Secondary	Proportion of premature discontinuations of the study or discontinuations of the product under study		14 days
Secondary	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
Secondary	Proportion of participants - satisfied or very satisfied - judging the use easy or very easy		14 days