Allergic RhinitisSPRANCT05443945
Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing Symptoms of Allergic Rhinitis
A study testing Nasal Spray in people with Allergic Rhinitis, run by P & B Group at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Nasal Spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 11 sitesFrance
- Study dates
- 30 Aug 2022to 14 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CH Aix Maupertuis
Aix-en-Provence, 13100
CHR Metz-Thionville
Ars-Laquenexy, 57530
GHEF
Jossigny, Seine Et Marne, 77600
Cabinet Libéral
Lille, 59000
Hôpital Saint Vincent
Lille, 59000
Cabinet libéral
Manosque, 04100
Hôpital Nord - APHM
Marseille, 13015
CHU Montpellier
Montpellier, 34000
Centre d'allergologie de Gentilly
Nancy, 54000
Cabinet Libéral
Paris, 75014
Alyatec
Strasbourg, 67000
About this study
Official title: Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing Symptoms of Allergic Rhinitis: Randomized, Double-blind, Placebo-controlled Trial
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
- Being tested
- Nasal Spray
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal SprayDevice
3 sprays in each nostril 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| Advanced Water -100 ionized nasal spray | Experimental | 3 sprays in each nostril, 3 times a day during 14 days Receives: Device: Nasal Spray |
| Nasal spray with purified water | Placebo comparator | 3 sprays in each nostril, 3 times a day during 14 days Receives: Device: Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 14 days
Secondary outcomes (9)
percentage of change on D4 and D14 compared to D0 of symptoms (nasal obstruction, sneezing, rhinorrhea, sore throat)
Measured: 14 days
percentage of change on D4 and D14 compared to D0 of eye symptoms (itching, tearing, redness)
Measured: 14 days
VAS from D0 to D14
minimum 0 and maximum 100 (higher scores mean a worse outcome)
Measured: 14 days
Allergic rhinitis control test on D0 and D14
Measured: 14 days
percentage of patients without symptoms at D4 and D14
Measured: 14 days
percentage of patients who used antihistamines
Measured: 14 days
Proportion of premature discontinuations of the study or discontinuations of the product under study
Measured: 14 days
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
Measured: 14 days
Proportion of participants - satisfied or very satisfied - judging the use easy or very easy
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start30 Aug 2022
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- P & B Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MediAxe CRO
- Responsible party
- Sponsor
- Investigators
- Sébastien Lefevre, Dr, Principal investigator, CHR Metz-Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443945
- Sponsor's protocol ID
- IC2-2111.11NS
- Acronym
- SPRA
- Status last verified
- Sep 2023
- First submitted
- 24 Jun 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing Symptoms of Allergic Rhinitis: Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05443945
- Acronym / sponsor ID
- SPRA / IC2-2111.11NS
- Conditions
- Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- P & B GroupIndustry (pharma, biotech, devices)
- Collaborators
- MediAxe CRO
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled study With a 4-7 days run-in period before a 14 days treatment/placebo period
| Arm | Type | Receives |
|---|---|---|
| Advanced Water -100 ionized nasal spray | Experimental | Device: Nasal Spray3 sprays in each nostril, 3 times a day during 14 days |
| Nasal spray with purified water | Placebo comparator | Device: Nasal Spray3 sprays in each nostril, 3 times a day during 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal Spray3 sprays in each nostril 3 times per day | Device | Advanced Water -100 ionized nasal spray, Nasal spray with purified water |
Primary outcome
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)
9 secondary outcomes
percentage of change on D4 and D14 compared to D0 of symptoms (nasal obstruction, sneezing, rhinorrhea, sore throat)
Time frame: 14 days
percentage of change on D4 and D14 compared to D0 of eye symptoms (itching, tearing, redness)
Time frame: 14 days
VAS from D0 to D14
Time frame: 14 days
Allergic rhinitis control test on D0 and D14
Time frame: 14 days
percentage of patients without symptoms at D4 and D14
Time frame: 14 days
percentage of patients who used antihistamines
Time frame: 14 days
Proportion of premature discontinuations of the study or discontinuations of the product under study
Time frame: 14 days
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
Proportion of participants - satisfied or very satisfied - judging the use easy or very easy
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
Related trials for Allergic Rhinitis
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RecruitingPhase 3
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RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
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Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien Lefevre, Dr principal investigator
CHR Metz-Thionville
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Spray in people with Allergic Rhinitis, run by P & B Group at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients with a change of at least 23 mm VAS (Visual Analogue Scale) at D4 (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.