Upper Resp Tract InfectionAIRNCT07267689
Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children
A study testing Treatment (22‰ Hypertonic seawater aerosol therapy solution) in people with Upper Resp Tract Infection and Rhinitis Acute, run by Laboratoires Gilbert at 4 sites in Poland.
Trial summary
The purpose of this study is to evaluate the tolerance, the performance and safety of this device, 22‰ Hypertonic seawater aerosol therapy solution in unidose container, to treat adult and peadiatric patients with of upper respiratory tract infection such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Upper Resp Tract Infection, Rhinitis Acute, Rhinopharyngitis
- What is being tested?
- Treatment (22‰ Hypertonic seawater aerosol therapy solution)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesPoland
- Study dates
- 21 Apr 2026to 18 May 2026
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult subject voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures.
- Minor subjects (7-17 years old) given informed assent to investigation participation in writing encompassing consent to data recording and verification procedures
- Male and female subjects, aged from 2 years old;
- Subject diagnosed with URTIs such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold based on the medical examination done by the doctor.
- Subject willing to adhere to the requirements of the protocol, including availability for follow-up visits
- Subject who agrees to no use decongestants, corticosteroids, antibiotics, allergen-specific immunotherapy, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), local nasal antiseptics, other nasal saline solutions or irrigations, nasal sprays, nasal creams or gels, systemic analgesics or antipyretics (except paracetamol if needed);
Show all 9Show fewer
- Subject who is able to comply with the study requirements, at the Investigator's appreciation.
- For minor (<18) subjects, parents/guardians willing and able to sign written consent
- Subject able and willing to use an internet-enabled device (computer, tablet, or smartphone) to complete study procedures (online questionnaires) and have regular access to a device with internet connectivity (personal or household device) for the duration of the study.
Who cannot join
- Person with hypersensitivity to seawater
- Subject who previously undergone bronchospasm
- Children under 2 years of age
- Pregnant and breastfeeding women
- Onset of URTI symptoms > 48 hours
- Subject with COVID or flu
Show all 19Show fewer
- Subject presenting alarm symptoms (periorbital oedema/erythema, displaced globe, double vision, ophthalmoplegia, reduced visual acuity, severe headache, frontal swelling, signs of sepsis, sign of meningitis, neurological signs) at the day of inclusion
- Subject known to have allergy to the components of the masks that is used with the inhalation device;
- Subject with asthma,
- Subject presenting infection or pathology of the inferior respiratory tracts;
- Subject with chronic nasal obstruction (polypes)
- Subject who used any decongestants, corticosteroids, antibiotics or allergen-specific immunotherapy within 4 weeks prior to inclusion;
- Subject who used any antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs) or local nasal antiseptics within 7 days prior to inclusion;
- Subject who used any nasal saline solutions or irrigations, nasal sprays, nasal creams or gels, systemic analgesics or antipyretics within 24 hours prior to inclusion;
- Subject with drug or alcohol abuse
- Subjects who is deprived for their freedom by administrative or legal decision
- Subject living in a social or sanitary establishment.
- Subject being in an exclusion period for a previous study or with a current or recent (<3 months) participation in another investigational study involving a drug or combined device with drug.
- Other condition preventing the subject to participate the study in the investigator's opinion: subject deemed unreliable or incapable of understanding and complying with the study assessment or unrealistic expectations of treatment results
Trial locations and contacts
4 sites in 1 country.
Poland4 sites
Centrum Medyczne PZU Zdrowie
Kielce, 25-017
Centrum Medyczne Zdrowie
Kielce, 25-713
Centrum Nowoczesnych Terapii "Dobry Lekarz"
Krakow, 31-011
Krajmed Centrum Medyczne
Warsaw, 02-743
About this study
Official title: Performance and Safety Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children With Upper Respiratory Tract Infection: a Prospective and Multicenter Study
The purpose of this study is to evaluate the tolerance, the performance and safety of this device, 22‰ Hypertonic seawater aerosol therapy solution in unidose container, to treat adult and peadiatric patients with of upper respiratory tract infection such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold.
The main questions it aims to answer are to assess if the 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation:
Read more
- improve nasal symptoms relief;
- improve sleep quality;
- improve mucus fluidizing;
- is safe and well tolerated.
The study is none comparative and will assess prospectively the symptomatic and functional benefits, the tolerance and the general safety of the medical device when used as an aerosol therapy solution, measured by change from baseline.
Treatments will be done at home and participants will be required to perform two on sites visits and to complete questionnaires and scales for 7 consecutive days from the treatment starting.
Read the detailed description
Hypertonic seawater-based solution is a simple and well-known product. The performance of these solutions has been established in paediatric (infants, children), and in adult populations. The mode of action is based on the physical (mechanical) osmotic effect of the solution. Hypertonic saline induces an osmotic flow of water into the mucus layer, rehydrating the airway surface liquid and improving mucus clearance. Hypertonic saline also reduces viscosity and elasticity of mucus.
Hypertonic saline solution (seawater based or not) can be used for intranasal wash, or in association with a nebulization system as an aerosol therapy solution for inhalation. Inhalation via nebulization allows the formation of fine particles or liquid droplets in a gas.
In this study, 22‰ Hypertonic seawater solution, in unidose container, manufactured by Laboratoires Gilbert will be used as an aerosol therapy solution for inhalation in the treatment of URTIs such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold. The investigational medical device 22‰ Hypertonic seawater solution from Laboratoires Gilbert will be used in association with a nebulization system.
The purpose of this study is to evaluate the tolerance, the performance and safety of this device, 22‰ Hypertonic seawater aerosol therapy solution in unidose container, to treat adult and peadiatric patients with of upper respiratory tract infection such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold.
The main questions it aims to answer are to assess if the 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation:
- improve nasal symptoms relief;
- improve sleep quality;
- improve mucus fluidizing;
- is safe and well tolerated.
The study is none comparative and will assess prospectively the symptomatic and functional benefits, the tolerance and the general safety of the medical device when used as an aerosol therapy solution, measured by change from baseline.
Treatments will be done at home and participants will be required to perform two on sites visits and to complete questionnaires and scales for 7 consecutive days from the treatment starting.
- Conditions
- Upper Resp Tract Infection, Rhinitis Acute, Rhinopharyngitis, Cold Symptom, Rhinitis Viral
- Being tested
- Treatment (22‰ Hypertonic seawater aerosol therapy solution)
- Keywords
- hypertonic seawater, upper respiratory tract infection (URTIs), inhalation, nebulization
- Medical subject headings
- Respiratory Tract Infections, Common Cold, Nasopharyngitis, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment (22‰ Hypertonic seawater aerosol therapy solution)Device
Treatment twice a day for 7 consecutive days with 22‰ Hypertonic seawater aerosol therapy solution used in association with a nebulizer
| Study group | Role | What they receive |
|---|---|---|
| Patient treated with 22‰ Hypertonic seawater solution, used as aerosol therapy for inhalati | Experimental | 5mL of 22‰ Hypertonic seawater per treatments, 14 treatments on 7 consecutive days Receives: Device: Treatment (22‰ Hypertonic seawater aerosol therapy solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-21 questionnaire in minor patients from 14 years old and adults.
Change in global WURSS-21 score as measured in the morning before treatment on Day 1 and Day 3 .
Measured: From Day 1 to Day 3
Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-K questionnaire in minor patients from 4 to 13 years old.
Change in global WURSS-K score as measured in the morning before treatment on Day 1 and Day 3.
Measured: From Day 1 to Day 3
Secondary outcomes (13)
Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-21 questionnaire in minor patients from 14 years old and adults.
Change in global WURSS-21 score as measured in the morning before treatment at Day2, at Day 4, at Day 5, at Day 6, at Day 7 and at Day 8 compared to Day 1 (before treatment) as baseline.
Measured: Day 1, Day 2, Day 4, Day 5, Day 6, Day 7 and Day 8
Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-K questionnaire in minor patients from 4 to 13 years old.
Change in global WURSS-K score as measured in the morning before treatment at Day 2, at Day 4, at Day 5, at Day 6, at Day 7 and at Day 8 compared to Day 1 (before treatment) as baseline.
Measured: Day 1, Day 2, Day 4, Day 5, Day 6, Day 7 and Day 8
Assess the immediate benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.
Change in VAS (Visual Analog Scale) score before and immediately after treatment (nasal symptom relief).
Measured: Day 1, Day 3, Day 5 and Day 7
Assess the proportion of patients that note an immediate benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.
Proportion of patients reporting improvement in nasal symptom relief (defined as a VAS increase of more than 3 points on a 10-point scale) immediately after treatment.
Measured: Day 1, Day 3, Day 5 and Day 7
Assess the sustained benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.
Change in VAS (Visual Analog Scale) score before treatment and 3 hours post-treatment (nasal symptom relief).
Measured: Day 1, Day 3, Day 5 and Day 7
Assess the proportion of patients that note a sustained benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief during the day.
Proportion of patients reporting improvement in nasal symptom relief (defined as a VAS increase of more than 3 points on a 10-point scale) 3 hours post- treatment
Measured: Day 1, Day 3, Day 5 and Day 7
Assess the benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation in improving sleep quality.
Improvement in sleep quality defined as a VAS score increase of more than 3 points on a 10-point scale, in the morning following evening treatment compared to baseline (assessment at Day 1 before treatment regarding the sleep quality during the night between Day 0 and Day 1).
Measured: Day 1 before treatment, Day 2, Day 3, Day 5 and Day 7
Assess the proportion of patients reporting an improvement of sleep quality following evening treatment with the of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation.
Proportion of patients reporting improvement in sleep quality (defined as a VAS increase of more than 3 points on a 10-point scale), in the morning following evening treatment with the device compared to baseline (assessment at Day 1 before treatment regarding the sleep quality during the night between Day 0 and Day 1)
Measured: Day 1 before treatment, Day 2, Day 3, Day 5 and Day 7
Evaluate the performance of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on the improvement of mucus fluidizing
Assess performance to improve mucus fluidizing (6-point Likert scale) 6-point-Likert scale: 0 (None) - 1 (Very mild) - 2 (Mild) - 3 (Moderate) - 4 (Strong) - 5 (Very strong). Lower score means a worse outcome.
Measured: Day 1, Day 3, Day 5, Day 7
Evaluate the overall patient's satisfaction.
Assessment by the patient of the overall satisfaction through 5-point Likert scale ((1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied)) at Day 8.
Measured: Day 8
Evaluate the overall tolerance of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation.
Assessment by the investigator of the occurrence of adverse device effect related to the use of 22‰ Hypertonic seawater solution when used as aerosol therapy solution for inhalation.
Measured: From Day 1 to Day 7
Evaluate the overall safety of 22‰ Hypertonic seawater solution throughout the study.
Assessment by the investigators of the occurrence and severity of adverse events (AE)
Measured: From Day 0 to Day 8
Evaluate the device related complications rates throughout the study.
Assessment of the proportion of patients with at least one adverse device effect related to the use of 22‰ Hypertonic seawater solution as an aerosol therapy solution for inhalation .
Measured: From Day 1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start21 Apr 2026
- Primary completion18 May 2026
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Resp Tract InfectionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pivotal clinical investigation Interventional, prospective, non-comparative, open, multicentric
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Gilbert
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sebastian Kędzierski, Dr., Principal investigator, Centrum Medyczne PZU ZdrowieMichal Tyrek, Dr., Principal investigator, Centrum Medyczne Pratia Częstochowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267689
- Sponsor's protocol ID
- MAR-2022-0832
- Acronym
- AIR
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children With Upper Respiratory Tract Infection: a Prospective and Multicenter Study
- ClinicalTrials.gov ID
- NCT07267689
- Acronym / sponsor ID
- AIR / MAR-2022-0832
- Conditions
- Upper Resp Tract Infection, Rhinitis Acute, Rhinopharyngitis, Cold Symptom, Rhinitis Viral
- Keywords
- hypertonic seawater, upper respiratory tract infection (URTIs), inhalation, nebulization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Laboratoires GilbertIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 5 Dec 2025 (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 purpose of this study is to evaluate the tolerance, the performance and safety of this device, 22‰ Hypertonic seawater aerosol therapy solution in unidose container, to treat adult and peadiatric patients with of upper respiratory tract infection such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold.
The main questions it aims to answer are to assess if the 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation:
- improve nasal symptoms relief;
- improve sleep quality;
- improve mucus fluidizing;
- is safe and well tolerated.
The study is none comparative and will assess prospectively the symptomatic and functional benefits, the tolerance and the general safety of the medical device when used as an aerosol therapy solution, measured by change from baseline.
Treatments will be done at home and participants will be required to perform two on sites visits and to complete questionnaires and scales for 7 consecutive days from the treatment starting.
Detailed description
Hypertonic seawater-based solution is a simple and well-known product. The performance of these solutions has been established in paediatric (infants, children), and in adult populations. The mode of action is based on the physical (mechanical) osmotic effect of the solution. Hypertonic saline induces an osmotic flow of water into the mucus layer, rehydrating the airway surface liquid and improving mucus clearance. Hypertonic saline also reduces viscosity and elasticity of mucus.
Hypertonic saline solution (seawater based or not) can be used for intranasal wash, or in association with a nebulization system as an aerosol therapy solution for inhalation. Inhalation via nebulization allows the formation of fine particles or liquid droplets in a gas.
In this study, 22‰ Hypertonic seawater solution, in unidose container, manufactured by Laboratoires Gilbert will be used as an aerosol therapy solution for inhalation in the treatment of URTIs such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold. The investigational medical device 22‰ Hypertonic seawater solution from Laboratoires Gilbert will be used in association with a nebulization system.
The purpose of this study is to evaluate the tolerance, the performance and safety of this device, 22‰ Hypertonic seawater aerosol therapy solution in unidose container, to treat adult and peadiatric patients with of upper respiratory tract infection such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold.
The main questions it aims to answer are to assess if the 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation:
- improve nasal symptoms relief;
- improve sleep quality;
- improve mucus fluidizing;
- is safe and well tolerated.
The study is none comparative and will assess prospectively the symptomatic and functional benefits, the tolerance and the general safety of the medical device when used as an aerosol therapy solution, measured by change from baseline.
Treatments will be done at home and participants will be required to perform two on sites visits and to complete questionnaires and scales for 7 consecutive days from the treatment starting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pivotal clinical investigation Interventional, prospective, non-comparative, open, multicentric
| Arm | Type | Receives |
|---|---|---|
| Patient treated with 22‰ Hypertonic seawater solution, used as aerosol therapy for inhalati | Experimental | Device: Treatment (22‰ Hypertonic seawater aerosol therapy solution)5mL of 22‰ Hypertonic seawater per treatments, 14 treatments on 7 consecutive days |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Adult subject voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures.
- Minor subjects (7-17 years old) given informed assent to investigation participation in writing encompassing consent to data recording and verification procedures
- Male and female subjects, aged from 2 years old;
- Subject diagnosed with URTIs such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold based on the medical examination done by the doctor.
- Subject willing to adhere to the requirements of the protocol, including availability for follow-up visits
Key exclusion criteria (19 listed)
- Person with hypersensitivity to seawater
- Subject who previously undergone bronchospasm
- Children under 2 years of age
- Pregnant and breastfeeding women
- Onset of URTI symptoms > 48 hours
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 |
|---|---|---|
| Treatment (22‰ Hypertonic seawater aerosol therapy solution)Treatment twice a day for 7 consecutive days with 22‰ Hypertonic seawater aerosol therapy solution used in association with a nebulizer | Device | Patient treated with 22‰ Hypertonic seawater solution, used as aerosol therapy for inhalati |
Primary outcome
- Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-21 questionnaire in minor patients from 14 years old and adults.
Time frame: From Day 1 to Day 3
Change in global WURSS-21 score as measured in the morning before treatment on Day 1 and Day 3 .
Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-K questionnaire in minor patients from 4 to 13 years old.
Time frame: From Day 1 to Day 3
Change in global WURSS-K score as measured in the morning before treatment on Day 1 and Day 3.
13 secondary outcomes
Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-21 questionnaire in minor patients from 14 years old and adults.
Time frame: Day 1, Day 2, Day 4, Day 5, Day 6, Day 7 and Day 8
Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-K questionnaire in minor patients from 4 to 13 years old.
Time frame: Day 1, Day 2, Day 4, Day 5, Day 6, Day 7 and Day 8
Assess the immediate benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.
Time frame: Day 1, Day 3, Day 5 and Day 7
Assess the proportion of patients that note an immediate benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.
Time frame: Day 1, Day 3, Day 5 and Day 7
Assess the sustained benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.
Time frame: Day 1, Day 3, Day 5 and Day 7
Assess the proportion of patients that note a sustained benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief during the day.
Time frame: Day 1, Day 3, Day 5 and Day 7
Assess the benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation in improving sleep quality.
Time frame: Day 1 before treatment, Day 2, Day 3, Day 5 and Day 7
Assess the proportion of patients reporting an improvement of sleep quality following evening treatment with the of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation.
Time frame: Day 1 before treatment, Day 2, Day 3, Day 5 and Day 7
Evaluate the performance of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on the improvement of mucus fluidizing
Time frame: Day 1, Day 3, Day 5, Day 7
Evaluate the overall patient's satisfaction.
Time frame: Day 8
Evaluate the overall tolerance of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation.
Time frame: From Day 1 to Day 7
Evaluate the overall safety of 22‰ Hypertonic seawater solution throughout the study.
Time frame: From Day 0 to Day 8
Evaluate the device related complications rates throughout the study.
Time frame: From Day 1 to Day 7
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 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Sebastian Kędzierski, Dr. principal investigator
Centrum Medyczne PZU Zdrowie
Michal Tyrek, Dr. principal investigator
Centrum Medyczne Pratia Częstochowa
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment (22‰ Hypertonic seawater aerosol therapy solution) in people with Upper Resp Tract Infection and Rhinitis Acute, run by Laboratoires Gilbert at 4 sites 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 9 inclusion and 19 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 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
- Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-21 questionnaire in minor patients from 14 years old and adults. (time frame: From Day 1 to Day 3). The study lists 2 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 23 Jul 2026.