Healthy Subjects (HS)PHARISNCT06613906
Prevention With Healsea in Adults Against Respiratory Infection Study
A study testing Healsea Children nasal spray in people with Healthy Subjects (HS), run by Lallemand Pharma AG at 1 site in Bulgaria.
Trial summary
Healsea® Children is a class IIa medical device. This is an isotonic seawater-based nasal spray supplemented with a natural Symbiofilm™ extract (0.02%) isolated from marine bacteria. Healsea® Children is indicated in children above 6 years to clean and moisten the nose during colds. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects (HS)
- What is being tested?
- Healsea Children nasal spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteBulgaria
- Study dates
- 29 Nov 2024to 28 Apr 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be enrolled if they meet all the following criteria:
- Healthy Male/Female subjects ≥18 years
- No respiratory tract infection within 15 days before trial entry and at trial entry
- Willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the information consent form
- Availability of a smartphone throughout the study and an internet connection.
Who cannot join
- Subjects will not be enrolled if one of the following criteria is present:
- Known hypersensitivity/allergy to any component of the test device
- Subject with COPD, severe asthma, perennial allergy, immunodeficiency or cystic fibrosis
- Body temperature ≥ 37.8°C
- Medical history or any current disease that is considered by the investigator as a reason for non-inclusion
- Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps
Show all 14Show fewer
- Antibiotic (systemic or per nasal route) or antivirals (systemic) intake within 2 weeks before screening
- Systemic or local corticosteroids (nasal route or inhalation) within 4 weeks before screening
- Antihistamines intake for allergy when treatment was started from less than 4 weeks before screening
- Vaccination against flu or COVID-19 within 6 months before screening
- Chronic decongestant use within 2 weeks before screening
- Bacterial lysates, or immunostimulants (food supplements excluded) used for prevention of infection within the 6 months before the screening
- Prebiotics, probiotics used for prevention of infection within 6 months before the screening
- Pregnant/Lactating female or of childbearing potential without hormonal contraception or intrauterine device or double barrier method.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Healsea® Isotonic Nasal Spray in the Prevention of Upper Respiratory Tract Infections With Nasal Symptoms in Adults: a Pre-market Study
Healsea® Children is a class IIa medical device. This is an isotonic seawater-based nasal spray supplemented with a natural Symbiofilm™ extract (0.02%) isolated from marine bacteria. Healsea® Children is indicated in children above 6 years to clean and moisten the nose during colds.
Symbiofilm™, which is not a medicinal product is able to protect the nasal mucosa from viruses entrance by forming a protective barrier on the nasal mucosa.
Read more
By targeting the nose as entry points for viruses, we hypothesise that Healsea® Children used regularly during the respiratory virus season may prevent upper respiratory tracts infections such as cold or flu with nasal symptoms not only in children (HEALSPIC study, NCT06582589) but also in adults.
The main objective of this premarket clinical investigation is thus to assess the efficacy of Healsea® Children to prevent upper respiratory tract infections with nasal symptoms in healthy adults during 3 treatment periods of 28 days interspersed by 2 wash-out periods of 10 days when compared to adults not taking Healsea® Children.
198 adults will be randomised in the study, 99 in the Healsea® Children group and 99 in the non-treated group.
The subjects will be asked to report the upper respiratory tract infections with nasal symptoms and complication they may have during the study to the physician in charge of the study conduct.
Two study visits and 3 telephone calls are scheduled. The subjects will also complete an electronic diary to report nasal symptoms and adverse events other than upper respiratory tracts infections.
Read the detailed description
Upper respiratory tract infections (URTIs) and sino-nasal symptoms are very frequent.
Human rhinovirus (more than 100 serotypes) is the most common cause, accounting up to 50% viral rhinitis episodes in children and adults. These episodes can last up to 7-10 days and are usually self-limited. Prevalence of acute rhinosinusitis varies with season (higher in the fall and winter months) and climatic variations and increases with a damp environment and air pollution. The incidence of acute rhinitis/rhinosinusitis is very high, estimated to occur from 2 to 5 times per year in the average adult.
Healsea® Children is a class IIa medical device. This is an isotonic seawater-based nasal spray supplemented with a natural Symbiofilm™ extract (0.02%) isolated from marine bacteria. Healsea® Children is indicated in children above 6 years to clean and moisten the nose during colds and rhinitis. The clinical performance of Healsea® Children is supported by the sea water solution and Symbiofilm™. The exact mechanisms by which nasal irrigation works are not known. However, most of the experts agree that it is primarily a mechanical intervention leading to direct cleaning of the nasal mucosa.
The other component of Healsea® Children, Symbiofilm™ is an exopolymeric composition with emulsifying/surfactant properties which enhance the cleansing and moistening of nasal mucosa. Furthermore, a prophylactic activity of Symbiofilm™ against infection by viruses involved in upper respiratory infections i.e., Adenovirus, Rhinovirus, Flu virus and OC 43 Coronavirus has been demonstrated in vitro on human nasal epithelial cells (HNEpC). The antiviral prophylactic activity of Symbiofilm™ is suggested to rely on its physiochemical properties that, by coating the surface of epithelial cells, hinders the viral entry process, thus explaining the reduced viral adsorption and the subsequent reduced onset of infection.
By targeting the nose as entry points for viruses, we hypothesise that Healsea® Children used regularly during the respiratory virus season may prevent upper respiratory tracts infections with nasal symptoms not only in children (HEALSPIC study, NCT06582589) but also in the adult population.
The aim of this two arms prospective randomized open-labelled pre-market clinical investigation, is to establish clinical benefits and clinical safety of Healsea® Children to prevent upper respiratory tract infections with nasal symptoms in healthy adults during 3 treatment periods of 28 days (one puff in each ostril twice daily) interspersed by 2 wash-out periods of 10 days when compared to adults not taking Healsea® Children.
198 children will be randomised in the study, 99 in the Healsea® Children group and 99 in the non-treated group.
The subjects will be asked to immediately call the investigator in case of nasal symptoms and complication of respiratory infection they may have during the study.
Two study visits (Visit 1, Screening/Randomisation at Day 1 and Visit 2, End of study visit at Day 106 up to Day 116) and 3 telephone calls (telephone call 1 TC1 at Day15 ±3 days, TC2 at Day 55 ±3 days and TC3 at Day 95±3days) are scheduled. The subjects will also complete an electronic diary to report nasal symptoms, device deficiencies, and adverse events other than upper respiratory tracts infections from D2 up to end of study (Day 106 up to Day 116).
The duration of patient\'s participation is up to 116 days.
- Conditions
- Healthy Subjects (HS)
- Being tested
- Healsea Children nasal spray
- Keywords
- saline nasal spray, upper respiratory tract infection, prevention
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healsea Children nasal sprayDevice
dosage: 1 puff in each nostril twice daily during 3 treatment periods of 28 days interspersed by 2 wash-out periods of 10 days
| Study group | Role | What they receive |
|---|---|---|
| Healsea Children treated group | Experimental | Subjects of this arm will be treated with Healsea Children nasal spray during 3 treatment periods of 28 days interspersed by 2 wash-out periods of 10 days |
| Untreated arm | No intervention | Subjects of this arm will not receive any treatment for the prevention of respiratory tract infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects without any upper respiratory tract infection (URTI) with nasal symptoms during the study.
The upper respiratory tracts infections with nasal symptoms (blocked nose, runny nose yellow or green discharge, sneezing ) will be collected for each subject throughout the study. An URTI episode with nasal symptoms is defined as follows: (i) at least 1 of the followings must be present: a blocked nose, runny nose, yellow or green nasal discharge, sneezing; (ii) the symptomatic episode must last for at least 3 days.
Measured: From the randomization up to Day 116
Secondary outcomes (5)
Number of Upper Respiratory Tract Infections with nasal symptoms during the study
Upper Respiratory Tract Infections with nasal symptoms will be reported by the subjects to the investigators during the whole study duration and the total number compared between groups
Measured: Time Frame: From the randomization up to Day 116
Number of Upper Respiratory Tract Infections complications
Complications of Upper respiratory Tract Infections (bronchitis, bronchiolitis, pneumoniae, pharyngo-tonsillitis, laryngitis, acute otitis) will be reported by the subjects during the whole study duration and compared between groups
Measured: Time Frame: From the randomization up to Day 116
Number of days of use of concomitant treatments that may affect Upper Respiratory Tract Infections symptoms and associated complications
The number of days of antipyretics intake, systemic or local mucolytics, decongestants, antitussives, systemic and per nasal route antibiotics, local and systemic corticosteroids, systemic antivirals) will be compared between the 2 arms
Measured: From the randomization up to Day 116
Number of school days lost due to Upper Respiratory Tract Infections and complications
Number of school days lost due to Upper Respiratory Tract Infections and complications will be collected during the whole study duration and compared between groups
Measured: From the randomization up to Day 116
Assessment of (serious) adverse events and device deficiences throughout the study
Measured: From the randomization up to Day 116
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start29 Nov 2024
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy Subjects (HS)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lallemand Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613906
- Sponsor's protocol ID
- LPH-2401
- Other IDs
- 2833/06/08/2024
- Acronym
- PHARIS
- Status last verified
- Jul 2025
- First submitted
- 23 Sep 2024
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Williamson S, Dennison L, Greenwell K, Denison-Day J, Mowbray F, Richards-Hall S, Smith D, Bradbury K, Ainsworth B, Little P, Geraghty AWA, Yardley L. Using nasal sprays to prevent respiratory tract infections: a qualitative study of online consumer reviews and primary care patient interviews. BMJ Open. 2022 Jun 30;12(6):e059661. doi: 10.1136/bmjopen-2021-059661.
PubMed 35772824Slapak I, Skoupa J, Strnad P, Hornik P. Efficacy of isotonic nasal wash (seawater) in the treatment and prevention of rhinitis in children. Arch Otolaryngol Head Neck Surg. 2008 Jan;134(1):67-74. doi: 10.1001/archoto.2007.19.
PubMed 18209140Tano L, Tano K. A daily nasal spray with saline prevents symptoms of rhinitis. Acta Otolaryngol. 2004 Nov;124(9):1059-62. doi: 10.1080/00016480410017657.
PubMed 15513550Jaume F, Valls-Mateus M, Mullol J. Common Cold and Acute Rhinosinusitis: Up-to-Date Management in 2020. Curr Allergy Asthma Rep. 2020 Jun 3;20(7):28. doi: 10.1007/s11882-020-00917-5.
PubMed 32495003
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Healsea® Isotonic Nasal Spray in the Prevention of Upper Respiratory Tract Infections With Nasal Symptoms in Adults: a Pre-market Study
- ClinicalTrials.gov ID
- NCT06613906
- Acronym / sponsor ID
- PHARIS / LPH-2401
- Conditions
- Healthy Subjects (HS)
- Keywords
- saline nasal spray, upper respiratory tract infection, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Lallemand Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 26 Sep 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.
Healsea® Children is a class IIa medical device. This is an isotonic seawater-based nasal spray supplemented with a natural Symbiofilm™ extract (0.02%) isolated from marine bacteria. Healsea® Children is indicated in children above 6 years to clean and moisten the nose during colds.
Symbiofilm™, which is not a medicinal product is able to protect the nasal mucosa from viruses entrance by forming a protective barrier on the nasal mucosa.
By targeting the nose as entry points for viruses, we hypothesise that Healsea® Children used regularly during the respiratory virus season may prevent upper respiratory tracts infections such as cold or flu with nasal symptoms not only in children (HEALSPIC study, NCT06582589) but also in adults.
The main objective of this premarket clinical investigation is thus to assess the efficacy of Healsea® Children to prevent upper respiratory tract infections with nasal symptoms in healthy adults during 3 treatment periods of 28 days interspersed by 2 wash-out periods of 10 days when compared to adults not taking Healsea® Children.
198 adults will be randomised in the study, 99 in the Healsea® Children group and 99 in the non-treated group.
The subjects will be asked to report the upper respiratory tract infections with nasal symptoms and complication they may have during the study to the physician in charge of the study conduct.
Two study visits and 3 telephone calls are scheduled. The subjects will also complete an electronic diary to report nasal symptoms and adverse events other than upper respiratory tracts infections.
Detailed description
Upper respiratory tract infections (URTIs) and sino-nasal symptoms are very frequent.
Human rhinovirus (more than 100 serotypes) is the most common cause, accounting up to 50% viral rhinitis episodes in children and adults. These episodes can last up to 7-10 days and are usually self-limited. Prevalence of acute rhinosinusitis varies with season (higher in the fall and winter months) and climatic variations and increases with a damp environment and air pollution. The incidence of acute rhinitis/rhinosinusitis is very high, estimated to occur from 2 to 5 times per year in the average adult.
Healsea® Children is a class IIa medical device. This is an isotonic seawater-based nasal spray supplemented with a natural Symbiofilm™ extract (0.02%) isolated from marine bacteria. Healsea® Children is indicated in children above 6 years to clean and moisten the nose during colds and rhinitis. The clinical performance of Healsea® Children is supported by the sea water solution and Symbiofilm™. The exact mechanisms by which nasal irrigation works are not known. However, most of the experts agree that it is primarily a mechanical intervention leading to direct cleaning of the nasal mucosa.
The other component of Healsea® Children, Symbiofilm™ is an exopolymeric composition with emulsifying/surfactant properties which enhance the cleansing and moistening of nasal mucosa. Furthermore, a prophylactic activity of Symbiofilm™ against infection by viruses involved in upper respiratory infections i.e., Adenovirus, Rhinovirus, Flu virus and OC 43 Coronavirus has been demonstrated in vitro on human nasal epithelial cells (HNEpC). The antiviral prophylactic activity of Symbiofilm™ is suggested to rely on its physiochemical properties that, by coating the surface of epithelial cells, hinders the viral entry process, thus explaining the reduced viral adsorption and the subsequent reduced onset of infection.
By targeting the nose as entry points for viruses, we hypothesise that Healsea® Children used regularly during the respiratory virus season may prevent upper respiratory tracts infections with nasal symptoms not only in children (HEALSPIC study, NCT06582589) but also in the adult population.
The aim of this two arms prospective randomized open-labelled pre-market clinical investigation, is to establish clinical benefits and clinical safety of Healsea® Children to prevent upper respiratory tract infections with nasal symptoms in healthy adults during 3 treatment periods of 28 days (one puff in each ostril twice daily) interspersed by 2 wash-out periods of 10 days when compared to adults not taking Healsea® Children.
198 children will be randomised in the study, 99 in the Healsea® Children group and 99 in the non-treated group.
The subjects will be asked to immediately call the investigator in case of nasal symptoms and complication of respiratory infection they may have during the study.
Two study visits (Visit 1, Screening/Randomisation at Day 1 and Visit 2, End of study visit at Day 106 up to Day 116) and 3 telephone calls (telephone call 1 TC1 at Day15 ±3 days, TC2 at Day 55 ±3 days and TC3 at Day 95±3days) are scheduled. The subjects will also complete an electronic diary to report nasal symptoms, device deficiencies, and adverse events other than upper respiratory tracts infections from D2 up to end of study (Day 106 up to Day 116).
The duration of patient\'s participation is up to 116 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healsea Children treated group | Experimental | –Subjects of this arm will be treated with Healsea Children nasal spray during 3 treatment periods of 28 days interspersed by 2 wash-out periods of 10 days |
| Untreated arm | No intervention | –Subjects of this arm will not receive any treatment for the prevention of respiratory tract infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy Male/Female subjects ≥18 years
- No respiratory tract infection within 15 days before trial entry and at trial entry
- Willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the information consent form
- Availability of a smartphone throughout the study and an internet connection.
Key exclusion criteria (14 listed)
- Known hypersensitivity/allergy to any component of the test device
- Subject with COPD, severe asthma, perennial allergy, immunodeficiency or cystic fibrosis
- Body temperature ≥ 37.8°C
- Medical history or any current disease that is considered by the investigator as a reason for non-inclusion
- Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps
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 |
|---|---|---|
| Healsea Children nasal spraydosage: 1 puff in each nostril twice daily during 3 treatment periods of 28 days interspersed by 2 wash-out periods of 10 days | Device | – |
Primary outcome
Proportion of subjects without any upper respiratory tract infection (URTI) with nasal symptoms during the study.
Time frame: From the randomization up to Day 116
The upper respiratory tracts infections with nasal symptoms (blocked nose, runny nose yellow or green discharge, sneezing ) will be collected for each subject throughout the study. An URTI episode with nasal symptoms is defined as follows: (i) at least 1 of the followings must be present: a blocked nose, runny nose, yellow or green nasal discharge, sneezing; (ii) the symptomatic episode must last for at least 3 days.
5 secondary outcomes
Number of Upper Respiratory Tract Infections with nasal symptoms during the study
Time frame: Time Frame: From the randomization up to Day 116
Number of Upper Respiratory Tract Infections complications
Time frame: Time Frame: From the randomization up to Day 116
Number of days of use of concomitant treatments that may affect Upper Respiratory Tract Infections symptoms and associated complications
Time frame: From the randomization up to Day 116
Number of school days lost due to Upper Respiratory Tract Infections and complications
Time frame: From the randomization up to Day 116
Assessment of (serious) adverse events and device deficiences throughout the study
Time frame: From the randomization up to Day 116
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 22 Jul 2025.
- Background: PubMed 35772824Williamson S, Dennison L, Greenwell K, Denison-Day J, Mowbray F, Richards-Hall S, Smith D, Bradbury K, Ainsworth B, Little P, Geraghty AWA, Yardley L. Using nasal sprays to prevent respiratory tract infections: a qualitative study of online consumer reviews and primary care patient interviews. BMJ Open. 2022 Jun 30;12(6):e059661. doi: 10.1136/bmjopen-2021-059661.
- Background: PubMed 18209140Slapak I, Skoupa J, Strnad P, Hornik P. Efficacy of isotonic nasal wash (seawater) in the treatment and prevention of rhinitis in children. Arch Otolaryngol Head Neck Surg. 2008 Jan;134(1):67-74. doi: 10.1001/archoto.2007.19.
- Background: PubMed 15513550Tano L, Tano K. A daily nasal spray with saline prevents symptoms of rhinitis. Acta Otolaryngol. 2004 Nov;124(9):1059-62. doi: 10.1080/00016480410017657.
- Background: PubMed 32495003Jaume F, Valls-Mateus M, Mullol J. Common Cold and Acute Rhinosinusitis: Up-to-Date Management in 2020. Curr Allergy Asthma Rep. 2020 Jun 3;20(7):28. doi: 10.1007/s11882-020-00917-5.
- 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.
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 Healsea Children nasal spray in people with Healthy Subjects (HS), run by Lallemand Pharma AG at 1 site in Bulgaria.
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 5 inclusion and 14 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 22 Jul 2025. 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 Bulgaria. 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?
Proportion of subjects without any upper respiratory tract infection (URTI) with nasal symptoms during the study. (time frame: From the randomization up to Day 116). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06613906, which also lists 4 linked publications.
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 22 Jul 2025.