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Trial record 1 of 1 for:    "SPRA"
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Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing Symptoms of Allergic Rhinitis (SPRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05443945
Recruitment Status : Recruiting
First Posted : July 5, 2022
Last Update Posted : February 21, 2023
Sponsor:
Collaborator:
MediAxe CRO
Information provided by (Responsible Party):
P & B Group

Study Description
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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.


Condition or disease Intervention/treatment Phase
Allergic Rhinitis Device: Nasal Spray Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized, double-blind, placebo-controlled study

With a 4-7 days run-in period before a 14 days treatment/placebo period
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing Symptoms of Allergic Rhinitis: Randomized, Double-blind, Placebo-controlled Trial
Actual Study Start Date : August 30, 2022
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05443945


Contacts
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Contact: PB Group +33 (0)0 00 00 00 00 contact@clinic-pbgroup.com

Locations
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France
GHEF Recruiting
Jossigny, Seine Et Marne, France, 77600
Contact: Marine Lelot, Dr         
CH Aix Maupertuis Active, not recruiting
Aix en Provence, France, 13100
CHR Metz-Thionville Recruiting
Ars-laquenexy, France, 57530
Contact: Sébastien Lefevre, Dr         
Cabinet Libéral Active, not recruiting
Lille, France, 59000
Hôpital Saint Vincent Active, not recruiting
Lille, France, 59000
Cabinet libéral Active, not recruiting
Manosque, France, 04100
CHU Montpellier Recruiting
Montpellier, France, 34000
Contact: Pascal Demoly, Pr         
Alyatec Recruiting
Strasbourg, France, 67000
Contact: Alina Gherasim, Dr         
Sponsors and Collaborators
P & B Group
MediAxe CRO
Investigators
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Principal Investigator: Sébastien Lefevre, Dr CHR Metz-Thionville
More Information
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Responsible Party: P & B Group
ClinicalTrials.gov Identifier: NCT05443945    
Other Study ID Numbers: IC2-2111.11NS
First Posted: July 5, 2022    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
 Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases