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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nasal Spray
Sponsored by
P & B Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GHEF
  • CH Aix Maupertuis
  • CHR Metz-Thionville
  • Cabinet Libéral
  • Hôpital Saint Vincent
  • Cabinet libéral
  • Hôpital Nord - APHM
  • CHU Montpellier
  • Centre d'allergologie de Gentilly
  • Cabinet Libéral
  • Alyatec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Advanced Water -100 ionized nasal spray

Nasal spray with purified water

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
June 24, 2022
Last Updated
September 19, 2023
Sponsor
P & B Group
Collaborators
MediAxe CRO
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1. Study Identification

Unique Protocol Identification Number
NCT05443945
Brief Title
Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing Symptoms of Allergic Rhinitis
Acronym
SPRA
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
August 14, 2023 (Actual)
Study Completion Date
August 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
P & B Group
Collaborators
MediAxe CRO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled study With a 4-7 days run-in period before a 14 days treatment/placebo period
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Advanced Water -100 ionized nasal spray
Arm Type
Experimental
Arm Description
3 sprays in each nostril, 3 times a day during 14 days
Arm Title
Nasal spray with purified water
Arm Type
Placebo Comparator
Arm Description
3 sprays in each nostril, 3 times a day during 14 days
Intervention Type
Device
Intervention Name(s)
Nasal Spray
Intervention Description
3 sprays in each nostril 3 times per day
Primary Outcome Measure Information:
Title
percentage of patients with a change of at least 23 mm VAS (Visual Analogue Scale) at D4
Description
minimum 0 and maximum 100 (higher scores mean a worse outcome)
Time Frame
14 days
Secondary Outcome Measure Information:
Title
percentage of change on D4 and D14 compared to D0 of symptoms (nasal obstruction, sneezing, rhinorrhea, sore throat)
Time Frame
14 days
Title
percentage of change on D4 and D14 compared to D0 of eye symptoms (itching, tearing, redness)
Time Frame
14 days
Title
VAS from D0 to D14
Description
minimum 0 and maximum 100 (higher scores mean a worse outcome)
Time Frame
14 days
Title
Allergic rhinitis control test on D0 and D14
Time Frame
14 days
Title
percentage of patients without symptoms at D4 and D14
Time Frame
14 days
Title
percentage of patients who used antihistamines
Time Frame
14 days
Title
Proportion of premature discontinuations of the study or discontinuations of the product under study
Time Frame
14 days
Title
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
Title
Proportion of participants - satisfied or very satisfied - judging the use easy or very easy
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Lefevre, Dr
Organizational Affiliation
CHR Metz-Thionville
Official's Role
Principal Investigator
Facility Information:
Facility Name
GHEF
City
Jossigny
State/Province
Seine Et Marne
ZIP/Postal Code
77600
Country
France
Facility Name
CH Aix Maupertuis
City
Aix en Provence
ZIP/Postal Code
13100
Country
France
Facility Name
CHR Metz-Thionville
City
Ars-laquenexy
ZIP/Postal Code
57530
Country
France
Facility Name
Cabinet Libéral
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hôpital Saint Vincent
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Cabinet libéral
City
Manosque
ZIP/Postal Code
04100
Country
France
Facility Name
Hôpital Nord - APHM
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Centre d'allergologie de Gentilly
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Cabinet Libéral
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Alyatec
City
Strasbourg
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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