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

NCT05443945 | Completed

• 1 other identifier: IC2-2111.11NS
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

  14 days

• Allergic rhinitis control test on D0 and D14

  14 days

• percentage of patients without symptoms at D4 and D14

  14 days

Study Arms (2)

Advanced Water -100 ionized nasal spray

EXPERIMENTAL

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

Device: Nasal Spray

Nasal spray with purified water

PLACEBO COMPARATOR

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

Device: Nasal Spray

Interventions

Nasal Spray DEVICE

3 sprays in each nostril 3 times per day

Advanced Water -100 ionized nasal spray; Nasal spray with purified water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Existence of links with any member of the study staff or the sponsor, or conflicts interests with the promoter
• Known hypersensitivity or allergy to one of the components of the product tested
• Contraindication to the use of a nasal spray
• 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
• Current treatment with systemic corticosteroids

Sponsors & Collaborators

• P & B Group: lead
• MediAxe CRO: collaborator

Study Sites (11)

GHEF

Jossigny, Seine Et Marne, 77600, France

Location

CH Aix Maupertuis

Aix-en-Provence, 13100, France

Location

CHR Metz-Thionville

Ars-Laquenexy, 57530, France

Location

Cabinet Libéral

Lille, 59000, France

Location

Hôpital Saint Vincent

Lille, 59000, France

Location

Cabinet libéral

Manosque, 04100, France

Location

Hôpital Nord - APHM

Marseille, 13015, France

Location

CHU Montpellier

Montpellier, 34000, France

Location

Centre d'allergologie de Gentilly

Nancy, 54000, France

Location

Cabinet Libéral

Paris, 75014, France

Location

Alyatec

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Sébastien Lefevre, Dr

  CHR Metz-Thionville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled study With a 4-7 days run-in period before a 14 days treatment/placebo period

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 5, 2022
• Study Start: August 30, 2022
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

FR (11)