RhinitisNCT06498843
Efficacy of Two Nasal Products Based on Diluted Seawater in the Treatment of Upper Respiratory Infections/Conditions
A study testing administration of an isotonic seawater solution (9g/L) in the nose and administration of a hypertonic seawater solution (21g/L) in the nose in people with Rhinitis and Sinusitis, run by YSLab at 1 site in Poland.
Trial summary
The goal of this interventional clinical trial is to test the safety and efficacy of two medical devices in subjects aged from 3 months old for the treatment of colds, rhinitis, sinusitis, and other upper respiratory infections/conditions for 7 days. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Rhinitis, Sinusitis, Upper Respiratory Infections
- What is being tested?
- administration of an isotonic seawater solution (9g/L) in the nose and administration of a hypertonic seawater solution (21g/L) in the nose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 sitePoland
- Study dates
- 18 Mar 2025to 14 May 2025
- 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 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Autonomous adult, or minor with the consent of their legal representative
- Adults and children from 3 months old
- Ability of the patient (for adults) or their legal representative (for children) to follow the instructions for product use
- Having signed a free and informed consent to participate in the study expressed by the patient (for adults) or by their legal representative (for children) after being informed by the doctor.
- Person with an upper respiratory tract infection (cold, rhinitis, rhinopharyngitis…) with symptoms of nasal congestion and nasal discharge of moderate to severe intensity (Jackson derived score (nasal congestion + nasal discharge) ≥ 4 on Day 0).
- Persons with symptoms that started no more than 48 hours before the first visit
Who cannot join
- Person not showing cold symptoms, particularly no nasal congestion (chronic dry rhinitis, or Jackson derived score (nasal congestion + nasal discharge) \< 4 on Day 0).
- Person undergoing treatment with a cortisone derivative, mucolytic, or medication containing pseudoephedrine or a similar product acting on nasal congestion or having used such a product within the 3 days preceding inclusion.
- Person having used a nasal wash product within the 3 days preceding inclusion.
- Person whose ability to use the product daily and complete the daily follow-up diary is in doubt.
- Person refusing to sign the informed consent form prior to the study.
- Person participating or having participated in any other clinical study within the 30 days preceding the study.
- Person participating in any other clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Effectiveness of Nasal Pump Spray Medical Devices DM004 and DM020 Based on Diluted Seawater in the Treatment of Colds, Rhinitis, Sinusitis, and Other Upper Respiratory Infections/Conditions
The goal of this interventional clinical trial is to test the safety and efficacy of two medical devices in subjects aged from 3 months old for the treatment of colds, rhinitis, sinusitis, and other upper respiratory infections/conditions for 7 days.
Read the detailed description
The main endpoint is a symptom score evaluation. Severity is evaluated using the Jackson scale, which includes 8 symptoms (nasal discharge, nasal congestion, sneezing, sore throat, cough, headache, discomfort, chills) rated as absent, mild, moderate, or severe by the physician/investigator, on Day 0, immediately after the first use, on Day 3, and on Day 7.
The clinical evaluation is also conducted by the ENT specialist using the CGI (Clinical Global Impression - 7-point scale) on Day 0, immediately after the first use, on Day 3, and on Day 7, and by patients using the PGI (Patient Global Impression - 7-point scale) every day.
Concomitant treatments, number and timing of daily use, and tolerance (adverse effects) will also be studied.
- Conditions
- Rhinitis, Sinusitis, Upper Respiratory Infections, Colds
- Being tested
- administration of an isotonic seawater solution (9g/L) in the nose, administration of a hypertonic seawater solution (21g/L) in the nose
- Medical subject headings
- Rhinitis, Sinusitis, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of an isotonic seawater solution (9g/L) in the noseOther
- pump spray group : people with an upper respiratory tract infection (cold, rhinitis, rhinopharyngitis, and other upper respiratory infections/conditions).
- sprays per nostril, at least 2 times a day up to 6 times a day. For 7 days
administration of a hypertonic seawater solution (21g/L) in the noseOther
- pump spray group : people with an upper respiratory tract infection (cold, rhinitis, rhinopharyngitis and other upper respiratory infections/conditions).
- sprays per nostril, at least 2 times a day up to 6 times a day. For 7 days
| Study group | Role | What they receive |
|---|---|---|
| DM004-Isotonic nasal pump spray group (9g/L) | Experimental | Isotonic concentration. This solution has a concentration of mineral salts (concentration of halides expressed as NaCl: 9 g/L) similar to the human cells. Receives: Other: administration of an isotonic seawater solution (9g/L) in the nose |
| DM020-Hypertonic nasal pump spray group (21g/L) | Experimental | Hypertonic concentration. This solution has a concentration of mineral salts (concentration of halides expressed as NaCl: 21 g/L) higher than that of human cells. Receives: Other: administration of a hypertonic seawater solution (21g/L) in the nose |
| common practices | No intervention | 1 control group with common practices people with an upper respiratory tract infection (cold, rhinitis, rhinopharyngitis...), not using nasal sprays nor nasal drops (in single-dose form, for example) but standard practices: hydration, rest, paracetamol if necessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the severity of Upper Respiratory Tract Symptoms (due to common cold, rhinitis, nasopharyngitis) using the Jackson scale.
The severity of 8 symptoms (nasal discharge, nasal congestion, sneezing, sore throat, cough, headache, discomfort, chills) will be measured by an ENT specialist using the Jackson scale, which ranges from 0 to 3 (0 : none, 1 : mild, 2 : moderate, 3 : severe). The results will be reported as overall scores in comparison to Day 0 (baseline) and relative to the control group.
Measured: on Day 0, immediately after the first use, Day 3, and Day 7.
Clinical global impression using a scale
This measure involves the clinical evaluation of the patient's condition by an ENT specialist using the Clinical Global Impression (CGI) scale, which utilizes a 7-point scale ((1: greatly improved; 2: moderately improved; 3: slightly improved; 4: unchanged; 5: slightly worsened; 6: moderately worsened; 7: greatly worsened).
Measured: on Day 0, immediately after the first use, Day 3, and Day 7
Patient global impression using a scale
This measure captures the patient's overall impression of their condition as perceived by the patient themselves. This subjective assessment will be recorded using a standardized 7-point scale ((1: greatly improved; 2: moderately improved; 3: slightly improved; 4: unchanged; 5: slightly worsened; 6: moderately worsened; 7: greatly worsened)), allowing comparison of their current state to the beginning of treatment. This provides insights into the patient's personal perception of their health status and treatment efficacy throughout the study period.
Measured: on Day 0, immediately after the first use, Day 3, and Day 7
Questionnaire on subject's satisfaction and use of devices
This measure involves the subject's daily self-assessment using a questionnaire. The questionnaire is designed to capture the subject's perceptions and expériences during the study period. Moreover, this questionnaire will allow us to record the number and time of daily use of the devices under study.
Measured: Day 7
Concomitant treatments using a questionnaire
This measure involves documenting any additional treatments or medications that participants may be receiving alongside the study intervention. It includes recording the types of treatments, their frequencies, durations, and any changes during the study period.
Measured: Immediately after the first use, Day 3, and Day 7
Collection of Side Effects Using a Questionnaire
This measure involves the daily recording of side effects experienced by participants. Side effects will be systematically documented each day, providing a comprehensive overview of the frequency and severity of adverse events throughout the study period. The number of patient with side effects will be notified
Measured: Immediately after the first use, Day 3, and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start18 Mar 2025
- Primary completion14 May 2025
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- YSLab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498843
- Sponsor's protocol ID
- STUU524AA0972
- Status last verified
- Aug 2026
- First submitted
- 27 Jun 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Effectiveness of Nasal Pump Spray Medical Devices DM004 and DM020 Based on Diluted Seawater in the Treatment of Colds, Rhinitis, Sinusitis, and Other Upper Respiratory Infections/Conditions
- ClinicalTrials.gov ID
- NCT06498843
- Acronym / sponsor ID
- STUU524AA0972
- Conditions
- Rhinitis, Sinusitis, Upper Respiratory Infections, Colds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- YSLabIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 12 Jul 2024 (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.
The goal of this interventional clinical trial is to test the safety and efficacy of two medical devices in subjects aged from 3 months old for the treatment of colds, rhinitis, sinusitis, and other upper respiratory infections/conditions for 7 days.
Detailed description
The main endpoint is a symptom score evaluation. Severity is evaluated using the Jackson scale, which includes 8 symptoms (nasal discharge, nasal congestion, sneezing, sore throat, cough, headache, discomfort, chills) rated as absent, mild, moderate, or severe by the physician/investigator, on Day 0, immediately after the first use, on Day 3, and on Day 7.
The clinical evaluation is also conducted by the ENT specialist using the CGI (Clinical Global Impression - 7-point scale) on Day 0, immediately after the first use, on Day 3, and on Day 7, and by patients using the PGI (Patient Global Impression - 7-point scale) every day.
Concomitant treatments, number and timing of daily use, and tolerance (adverse effects) will also be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DM004-Isotonic nasal pump spray group (9g/L) | Experimental | Other: administration of an isotonic seawater solution (9g/L) in the noseIsotonic concentration. This solution has a concentration of mineral salts (concentration of halides expressed as NaCl: 9 g/L) similar to the human cells. |
| DM020-Hypertonic nasal pump spray group (21g/L) | Experimental | Other: administration of a hypertonic seawater solution (21g/L) in the noseHypertonic concentration. This solution has a concentration of mineral salts (concentration of halides expressed as NaCl: 21 g/L) higher than that of human cells. |
| common practices | No intervention | –1 control group with common practices people with an upper respiratory tract infection (cold, rhinitis, rhinopharyngitis...), not using nasal sprays nor nasal drops (in single-dose form, for example) but standard practices: hydration, rest, paracetamol if necessary |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Autonomous adult, or minor with the consent of their legal representative
- Adults and children from 3 months old
- Ability of the patient (for adults) or their legal representative (for children) to follow the instructions for product use
- Having signed a free and informed consent to participate in the study expressed by the patient (for adults) or by their legal representative (for children) after being informed by the doctor.
- Person with an upper respiratory tract infection (cold, rhinitis, rhinopharyngitis…) with symptoms of nasal congestion and nasal discharge of moderate to severe intensity (Jackson derived score (nasal congestion + nasal discharge) ≥ 4 on Day 0).
Key exclusion criteria (7 listed)
- Person not showing cold symptoms, particularly no nasal congestion (chronic dry rhinitis, or Jackson derived score (nasal congestion + nasal discharge) \< 4 on Day 0).
- Person undergoing treatment with a cortisone derivative, mucolytic, or medication containing pseudoephedrine or a similar product acting on nasal congestion or having used such a product within the 3 days preceding inclusion.
- Person having used a nasal wash product within the 3 days preceding inclusion.
- Person whose ability to use the product daily and complete the daily follow-up diary is in doubt.
- Person refusing to sign the informed consent form prior to the study.
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 |
|---|---|---|
| administration of an isotonic seawater solution (9g/L) in the nose1. pump spray group : people with an upper respiratory tract infection (cold, rhinitis, rhinopharyngitis, and other upper respiratory infections/conditions). 2. sprays per nostril, at least 2 times a day up to 6 times a day. For 7 days | Other | DM004-Isotonic nasal pump spray group (9g/L) |
| administration of a hypertonic seawater solution (21g/L) in the nose1. pump spray group : people with an upper respiratory tract infection (cold, rhinitis, rhinopharyngitis and other upper respiratory infections/conditions). 2. sprays per nostril, at least 2 times a day up to 6 times a day. For 7 days | Other | DM020-Hypertonic nasal pump spray group (21g/L) |
Primary outcome
Measurement of the severity of Upper Respiratory Tract Symptoms (due to common cold, rhinitis, nasopharyngitis) using the Jackson scale.
Time frame: on Day 0, immediately after the first use, Day 3, and Day 7.
The severity of 8 symptoms (nasal discharge, nasal congestion, sneezing, sore throat, cough, headache, discomfort, chills) will be measured by an ENT specialist using the Jackson scale, which ranges from 0 to 3 (0 : none, 1 : mild, 2 : moderate, 3 : severe). The results will be reported as overall scores in comparison to Day 0 (baseline) and relative to the control group.
Clinical global impression using a scale
Time frame: on Day 0, immediately after the first use, Day 3, and Day 7
This measure involves the clinical evaluation of the patient's condition by an ENT specialist using the Clinical Global Impression (CGI) scale, which utilizes a 7-point scale ((1: greatly improved; 2: moderately improved; 3: slightly improved; 4: unchanged; 5: slightly worsened; 6: moderately worsened; 7: greatly worsened).
Patient global impression using a scale
Time frame: on Day 0, immediately after the first use, Day 3, and Day 7
This measure captures the patient's overall impression of their condition as perceived by the patient themselves. This subjective assessment will be recorded using a standardized 7-point scale ((1: greatly improved; 2: moderately improved; 3: slightly improved; 4: unchanged; 5: slightly worsened; 6: moderately worsened; 7: greatly worsened)), allowing comparison of their current state to the beginning of treatment. This provides insights into the patient's personal perception of their health status and treatment efficacy throughout the study period.
Questionnaire on subject's satisfaction and use of devices
Time frame: Day 7
This measure involves the subject's daily self-assessment using a questionnaire. The questionnaire is designed to capture the subject's perceptions and expériences during the study period. Moreover, this questionnaire will allow us to record the number and time of daily use of the devices under study.
Concomitant treatments using a questionnaire
Time frame: Immediately after the first use, Day 3, and Day 7
This measure involves documenting any additional treatments or medications that participants may be receiving alongside the study intervention. It includes recording the types of treatments, their frequencies, durations, and any changes during the study period.
Collection of Side Effects Using a Questionnaire
Time frame: Immediately after the first use, Day 3, and Day 7
This measure involves the daily recording of side effects experienced by participants. Side effects will be systematically documented each day, providing a comprehensive overview of the frequency and severity of adverse events throughout the study period. The number of patient with side effects will be notified
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 19 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing administration of an isotonic seawater solution (9g/L) in the nose and administration of a hypertonic seawater solution (21g/L) in the nose in people with Rhinitis and Sinusitis, run by YSLab at 1 site in Poland.
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 6 inclusion and 7 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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. 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?
Measurement of the severity of Upper Respiratory Tract Symptoms (due to common cold, rhinitis, nasopharyngitis) using the Jackson scale. (time frame: on Day 0, immediately after the first use, Day 3, and Day 7.). The study lists 6 primary outcomes in all. 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 19 Aug 2026.