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

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Device: Nasal Spray

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aix en Provence, France, 13100
    • CH Aix Maupertuis
  • Ars-laquenexy, France, 57530
    • CHR Metz-Thionville
  • Lille, France, 59000
    • Hopital Saint Vincent
  • Lille, France, 59000
    • Cabinet libéral
  • Manosque, France, 04100
    • Cabinet libéral
  • Marseille, France, 13015
    • Hôpital Nord - APHM
  • Montpellier, France, 34000
    • CHU Montpellier
  • Nancy, France, 54000
    • Centre d'allergologie de Gentilly
  • Paris, France, 75014
    • Cabinet libéral
  • Strasbourg, France, 67000
    • Alyatec
  • Seine Et Marne
    • Jossigny, Seine Et Marne, France, 77600
      • GHEF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Advanced Water -100 ionized nasal spray; 3 sprays in each nostril, 3 times a day during 14 days	Device: Nasal Spray; 3 sprays in each nostril 3 times per day
Placebo Comparator: Nasal spray with purified water; 3 sprays in each nostril, 3 times a day during 14 days	Device: Nasal Spray; 3 sprays in each nostril 3 times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: P & B Group
• Collaborators: MediAxe CRO
• Investigators: Principal Investigator: Sébastien Lefevre, Dr, CHR Metz-Thionville

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Actual): August 14, 2023
• Study Completion (Actual): August 14, 2023

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: IC2-2111.11NS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No