Clinical trial NCT05443945: Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing Symptoms of Allergic Rhinitis
Official title: Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing Symptoms of Allergic Rhinitis: Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Lead sponsor: P & B Group
Sponsor class: INDUSTRY
Collaborators: name: MediAxe CRO
First posted: 2022-07-05
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled study

With a 4-7 days run-in period before a 14 days treatment/placebo period
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: percentage of patients with a change of at least 23 mm VAS (Visual Analogue Scale) at D4
timeFrame: 14 days
Secondary outcomes:
measure: percentage of change on D4 and D14 compared to D0 of symptoms (nasal obstruction, sneezing, rhinorrhea, sore throat)
timeFrame: 14 days
measure: percentage of change on D4 and D14 compared to D0 of eye symptoms (itching, tearing, redness)
timeFrame: 14 days
measure: VAS from D0 to D14
timeFrame: 14 days
measure: Allergic rhinitis control test on D0 and D14
timeFrame: 14 days
measure: percentage of patients without symptoms at D4 and D14
timeFrame: 14 days
measure: percentage of patients who used antihistamines
timeFrame: 14 days
measure: Proportion of premature discontinuations of the study or discontinuations of the product under study
timeFrame: 14 days
measure: 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
timeFrame: 14 days
measure: Proportion of participants - satisfied or very satisfied - judging the use easy or very easy
timeFrame: 14 days
Other outcomes:
Locations:
city: Jossigny
country: France
facility: GHEF
state: Seine Et Marne
city: Aix en Provence
country: France
facility: CH Aix Maupertuis
city: Ars-laquenexy
country: France
facility: CHR Metz-Thionville
city: Lille
country: France
facility: Cabinet Libéral
city: Lille
country: France
facility: Hôpital Saint Vincent
city: Manosque
country: France
facility: Cabinet libéral
city: Marseille
country: France
facility: Hôpital Nord - APHM
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: Centre d'allergologie de Gentilly
city: Paris
country: France
facility: Cabinet Libéral
city: Strasbourg
country: France
facility: Alyatec
Study officials:
affiliation: CHR Metz-Thionville
name: Sébastien Lefevre, Dr
role: PRINCIPAL_INVESTIGATOR
References: