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Completed

NCT Number: NCT05443945

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHEF, Jossigny, Seine Et Marne, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Non-inclusion Criteria:

  • 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
  • Known pregnancy or positive urine pregnancy test at screening and/or at D0, or breastfeeding in progress
  • Participation in a clinical trial or other clinical investigation using a device medicine for the treatment or prevention of rhinitis or conjunctivitis

Treatment and study plan

nasal spray

Device

3 sprays in each nostril 3 times per day

Primary outcomes

  1. percentage of patients with a change of at least 23 mm VAS (Visual Analogue Scale) at D4

    Time frame: 14 days

    minimum 0 and maximum 100 (higher scores mean a worse outcome)

Secondary outcomes

  1. percentage of change on D4 and D14 compared to D0 of symptoms (nasal obstruction, sneezing, rhinorrhea, sore throat)

    Time frame: 14 days

  2. percentage of change on D4 and D14 compared to D0 of eye symptoms (itching, tearing, redness)

    Time frame: 14 days

  3. VAS from D0 to D14

    Time frame: 14 days

    minimum 0 and maximum 100 (higher scores mean a worse outcome)

  4. Allergic rhinitis control test on D0 and D14

    Time frame: 14 days

  5. percentage of patients without symptoms at D4 and D14

    Time frame: 14 days

  6. percentage of patients who used antihistamines

    Time frame: 14 days

  7. Proportion of premature discontinuations of the study or discontinuations of the product under study

    Time frame: 14 days

  8. 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

    Time frame: 14 days

  9. Proportion of participants - satisfied or very satisfied - judging the use easy or very easy

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

P & B Group

Industry

Collaborators

  • MediAxe CRO

Registry information

Official study title

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

Acronym: SPRA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 5, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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