An interventional study of administration of an isotonic seawater solution (9g/L) in the nose and administration of a hypertonic seawater solution (21g/L) in the nose in Rhinitis, Sinusitis and Upper Respiratory Infections, sponsored by YSLab. Completed at 1 site in Poland. Open to participants aged 3 Months and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by YSLab · Not applicable, Interventional, and Treatment
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.
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.
246 studies on the registry are indexed under Rhinitis; 22 are open to participants now.
This study's enrollment of 89 is above the median of 80 across 187 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →YSLab is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Isotonic concentration. This solution has a concentration of mineral salts (concentration of halides expressed as NaCl: 9 g/L) similar to the human cells.
Other: administration of an isotonic seawater solution (9g/L) in the nose
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.
Other: administration of a hypertonic seawater solution (21g/L) in the nose
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
1. 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
1. 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
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Immediately after the first use, Day 3, and Day 7
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2025 to primary completion in May 2025, 1 month.
Of 22 industry-sponsored interventional studies with no phase under Rhinitis, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 18. This study's 1 month is below that.
Counting every sponsor, half of 38 studies reached it within 11 months; a quarter within 5 and three quarters within 25.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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