Common ColdNCT05034328

Symbiofilm Trial in Allergic Kids (SYMBIOFILM-TAK)

An observational study of Common Cold and Allergy, run by Lallemand Pharma AG at 15 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Healsea® Children is a seawater-based nasal spray supplemented with a natural Symbiofilm® extract (0.02%) isolated from marine bacteria. Symbiofilm has antibiofilm activity against various bacterial pathogens involved in respiratory tract infections.Healsea® Children is indicated in the cleaning and moistening of… Read more about this study

Who is it for?: Ages 6 to 10 years
Conditions the study is for: Common Cold, Allergy
What is being tested?: Healsea® Children and Conventional therapies for common cold
Type of treatment: Medical device
How many people: 186 participants
Where: 15 sitesPoland
Study dates: 14 Feb 2022to 3 Nov 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 6 to 10 years
All sexes
No healthy volunteers
Child

Study population: The study population comprises children 6 to10 years old with perennial allergy and early symptoms of common cold. The recruitment will be competitive in both group, exposed to Healsea® Children or not exposed to Healsea® Children. However, when 100 patients will be recruited in one group, the recruitment will be stopped in this group but will continue in the other group until 100 patients to be enrolled.

Who may be able to join

Male/Female subjects ≥6 and ≤10-year-old
AsIgE (Allergy specific IgE) ≥ class 2 (RAST) or positive prick test for at least one perennial allergen
Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry
Patient presenting with fever ≥ 37.5 °C at screening
Symptoms of headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough, sneezing with a total score ≤9 (according to a physician-rated symptom score; scale: 0 to 3 [0: no symptom to 3: severe intensity])
At least one of these symptoms: sore throat, runny nose or blocked nose (i.e., with a score ≥1)
Written consent obtained from parent/legal guardians
Written assent obtained from patient

Who cannot join

Known hypersensitivity/allergy to any component of the test device
Medical history 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
History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores
Antibiotic intake within 2 weeks before screening
Systemic corticosteroids within 4 weeks before screening

Show all 10Show fewer

Antihistamines intake for allergy when treatment was started from less than 4 weeks
Bacterial lysate intake within 6 months before screening
Chronic decongestant use
Recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence symptom score at screening (NSAID, nasal decongestants, cough medicines)

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Poland15 sites

Research Site
Bialystok, 15-010
Research Site
Bialystok, 15-430
Research Site
Bydgoszcz, 85-048
Research Site
Dys, 21-003
Research Site
Głowno, 95-015
Research Site
Krakow, 30-644
Research Site
Łomża, 18-402
Research Site
Lublin, 20-093
Research Site
Lublin, 20-141
Research Site
Lublin, 20-552
Research Site
Lublin, 20-803
Research Site
Lublin, 20-865
Research Site
Rzeszów, 35-061
Research Site
Tarnów, 33-100
Research Site
Warsaw, 04-314

Other trials in Poland

About this study

Official title: Impact of Adding Healsea® Isotonic Nasal Spray to Conventional Therapies for the Care of Children With Allergic Rhinitis Presenting With Symptoms of Acute Infectious Rhinitis: an Observational Study

This non interventional post-market clinical investigation aimed to confirm the benefit of Healsea® Children in real life setting in children with perennial allergy who are more prone to common cold.

Read the detailed description

Healsea® Children is a seawater-based nasal spray supplemented with a natural Symbiofilm® extract (0.02%) isolated from marine bacteria. Symbiofilm® is an exopolymeric composition with emulsifying properties, in vitro antibiofilm activity and detachment properties against various bacterial pathogens involved in respiratory tract infections. Symbiofilm® has no bacteriostatic nor bactericidal activities. Healsea® Children is indicated in the cleaning and moistening of nasal mucosa during common cold and rhinitis.

The common cold is an acute viral infection of the upper respiratory tract, involving, to variable degrees, sneezing, nasal congestion and discharge (rhinorrhea), sore throat, cough, low-grade fever, headache, and malaise (1). It can be caused by members of several families of viruses; the most common are rhinoviruses. Acute viral rhinitis is generally self-limiting. In children where the illness is not self-limiting and extends beyond 7-10 days, many agree that a bacterial infection is likely (1). Bacterial over infections and progression to a chronic state are favoured by the formation of biofilms, which facilitate bacterial growth and persistence as well as reducing antibiotic efficacy (2-3).

Allergic diseases may play a particular role in promoting the respiratory infection recurrences (4). The physiological immune response is impaired in allergic subjects and allergic inflammation favours predisposition to respiratory infections. Subjects with allergic disorders may have functional defect of type 1 immune response that is relevant in fighting infections (5-6).

Allergic rhinitis (AR) may affect up to 40% of the paediatric population. Nasal symptoms are caused by exposure to an allergen to which a patient is sensitized.

AR is characterized by typical nasal symptoms and immunoglobulin E (IgE) -mediated inflammation. The allergic inflammatory process releases many cytokines and other proinflammatory proteins. Inflammation caused by nasal allergy leads to obstruction, fluid accumulation and acute disease. If these diseases are unsuccessfully treated, a chronic state of inflammation, obstruction, and infection develops that can cause mucosal damage and, ultimately, chronic disease (7).

For these reasons, the paediatric IgE-dependent allergic population that is more prone to common cold represents a suitable target for Healsea® Children (8-9).

During this prospective post-market clinical investigation, IgE-dependent allergic children with early symptoms of infectious rhinitis will be followed, children being treated with Healsea® Children on top of common cold conventional therapies or with conventional therapies only (excluded nasal irrigation).

Conventional therapies for non-complicated infectious rhinitis are symptomatic but are not without side effects. For example, decongestant use can increase blood pressure, antihistamine intake is associated with drowsiness.

Healsea® Children represents an interesting alternative that can not only improve acute infectious rhinitis symptomatology but could also limit the complication and progression to chronic state.

This non interventional post-market clinical investigation aimed to confirm the benefit of Healsea® Children in a real life setting in children with perennial allergy.

Conditions: Common Cold, Allergy
Being tested: Healsea® Children, Conventional therapies for common cold
Keywords: Infectious rhinitis, nasal irrigation, perennial allergy
Medical subject headings: Common Cold, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Healsea® ChildrenDevice
Also called Conventional therapies for common cold
Children will be administered Healsea Children , one puff (1-2 sec) in each nostril twice a day for 10 days on top of conventional therapies, as needed
Conventional therapies for common coldOther
Children will receive conventional therapies for common cold, nasal irrigation excluded (antipyretics, mucolytics, decongestants, antitussives, systemic and topical corticosteroids, antibiotics)

Study groups in NCT05034328
Study group	Role	What they receive
Healsea® Children: isotonic seawater based nasal spray supplemented with natural Symbiofilm® extract		Children will receive Healsea® Children nasal spray on top of conventional therapies for common cold, as needed. Receives: Device: Healsea® Children; Other: Conventional therapies for common cold
Conventional therapies		Children will receive conventional therapies for common cold as needed, nasal irrigation excluded Receives: Other: Conventional therapies for common cold

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC (Area Under Curve) of the Wisconsin Upper Respiratory Symptoms Survey for Kids (WURSS-K) During the 10-day Treatment Period
The WURSS-K will be assessed once daily, from Day1 to Day10 (treatment period) WURSS-K is a 3-dimensional structure questionnaire specifically designed for children 4 to 10 years of age.
It includes 6 items assessing symptoms (symptoms score: runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired), 7 items assessing functional impairments (quality of life score: think, sleep, breathe, talk, walk/climb stairs/exercise, go to school, play with friends), 1 item assessing global severity. All these items are scored from 0 (absent or no impairment) through 1 (a little bad), 2 (bad) and 3 (very bad). The AUC value of the WURSS-K during the 10 day- treatment period is comprised between 0 WURSS-K score*day (no impairement) and 420 WURSS-K score *day (maximal impairement)
Measured: Cumulative AUC of the WURSS score assessed from Day 1 to Day 10

Secondary outcomes (8)

Number of Days With Runny Nose
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of each common cold symptoms in both groups. Runny nose is the item 2
Measured: Number of days with runny nose during the 10-day treatment period and a follow-up of 20 days, up to 30 days
Number of Days With Stuffy Nose
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of each common cold symptoms in both groups. Stuffy nose is the item 3.
Measured: Number of days with stuffy nose during the 10-day treatment period and a follow-up period of 20 days, up to 30 days
Number of Days With Sneezing
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of common cold symptoms in both groups. Sneezing is the item 4.
Measured: Number of days with sneezing during the 10-day treatment period and a follow-up of 20 days, up to 30 days
Number of Days With Sore Throat
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of each common cold symptoms in both groups. Sore throat is the item 5.
Measured: Number of days with sore throat during the 10-day treatment period and a follow-up of 20 days, up to 30 days
Number of Days With Cough
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of each common cold symptoms in both groups. Cough is the item 6.
Measured: Number of days with cough during the 10-day treatment period and a follow-up of 20 days, up to 30 days
Number of Days With "Feeling Tired"
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of each common cold symptoms in both groups. Feeling tired is the item 7.
Measured: Number of days with "feeling tired" during the 10-day treatment period and a follow-up of 20 days, up to 30 days
Respiratory Complication Requiring Antibiotic Prescription After the10-day Treatment Period
The number of subjects who develop respiratory complication requiring antibiotic prescription during a 20-day follow-up period after the treatment period will be assessed in both groups and compared
Measured: Number of subjects with respiratory complications during the 20-day follow-up period
Number of Participants With Use of Concomitant Treatments
Number of subjects who took at least one concomitant treatment (antibiotics, antipyretics, systemic or local mucolytics, decongestants, antitussives, systemic and topical corticosteroids) that may impact symptoms of common cold and comparaison between groups
Measured: During 10-day treatment period and a follow-up period of 20 days, up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 20223 Nov 2022

First posted5 Sep 2021
Study start14 Feb 2022
Primary completion3 Nov 2022
Study completion3 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Common ColdStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05034328
Sponsor's protocol ID: LPH-2101
Status last verified: Mar 2023
First submitted: 2 Sep 2021
Last updated: 20 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600.
PubMed 32077450
Yan J, Bassler BL. Surviving as a Community: Antibiotic Tolerance and Persistence in Bacterial Biofilms. Cell Host Microbe. 2019 Jul 10;26(1):15-21. doi: 10.1016/j.chom.2019.06.002.
PubMed 31295420
Rabin N, Zheng Y, Opoku-Temeng C, Du Y, Bonsu E, Sintim HO. Biofilm formation mechanisms and targets for developing antibiofilm agents. Future Med Chem. 2015;7(4):493-512. doi: 10.4155/fmc.15.6.
PubMed 25875875
Varricchio A, La Mantia I, Brunese FP, Ciprandi G. Inflammation, infection, and allergy of upper airways: new insights from national and real-world studies. Ital J Pediatr. 2020 Feb 10;46(1):18. doi: 10.1186/s13052-020-0782-z.
PubMed 32039733
Ciprandi G, Tosca MA, Fasce L. Allergic children have more numerous and severe respiratory infections than non-allergic children. Pediatr Allergy Immunol. 2006 Aug;17(5):389-91. doi: 10.1111/j.1399-3038.2006.00413.x.
PubMed 16846459
Cirillo I, Marseglia G, Klersy C, Ciprandi G. Allergic patients have more numerous and prolonged respiratory infections than nonallergic subjects. Allergy. 2007 Sep;62(9):1087-90. doi: 10.1111/j.1398-9995.2007.01401.x. Epub 2007 Jun 18.
PubMed 17578494
Eifan AO, Durham SR. Pathogenesis of rhinitis. Clin Exp Allergy. 2016 Sep;46(9):1139-51. doi: 10.1111/cea.12780.
PubMed 27434218
De Corso E, Lucidi D, Cantone E, Ottaviano G, Di Cesare T, Seccia V, Paludetti G, Galli J. Clinical Evidence and Biomarkers Linking Allergy and Acute or Chronic Rhinosinusitis in Children: a Systematic Review. Curr Allergy Asthma Rep. 2020 Sep 5;20(11):68. doi: 10.1007/s11882-020-00967-9.
PubMed 32889648
Lin SW, Wang SK, Lu MC, Wang CL, Koo M. Acute rhinosinusitis among pediatric patients with allergic rhinitis: A nationwide, population-based cohort study. PLoS One. 2019 Feb 12;14(2):e0211547. doi: 10.1371/journal.pone.0211547. eCollection 2019.
PubMed 30753196

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Adding Healsea® Isotonic Nasal Spray to Conventional Therapies for the Care of Children With Allergic Rhinitis Presenting With Symptoms of Acute Infectious Rhinitis: an Observational Study
ClinicalTrials.gov ID: NCT05034328
Acronym / sponsor ID: LPH-2101
Conditions: Common Cold, Allergy
Keywords: Infectious rhinitis, nasal irrigation, perennial allergy
Study type: Observational
Recruitment status: Completed
Enrolment: 186 participants (actual)
Lead sponsor: Lallemand Pharma AGIndustry (pharma, biotech, devices)
Study start: 14 Feb 2022 (actual)
Primary completion: 3 Nov 2022 (actual)
Study completion: 3 Nov 2022 (actual)
First posted: 5 Sep 2021 (actual)
Results: Posted 20 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Allergic rhinitis (AR) may affect up to 40% of the paediatric population. Nasal symptoms are caused by exposure to an allergen to which a patient is sensitized.

For these reasons, the paediatric IgE-dependent allergic population that is more prone to common cold represents a suitable target for Healsea® Children (8-9).

Healsea® Children represents an interesting alternative that can not only improve acute infectious rhinitis symptomatology but could also limit the complication and progression to chronic state.

This non interventional post-market clinical investigation aimed to confirm the benefit of Healsea® Children in a real life setting in children with perennial allergy.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Healsea® Children: isotonic seawater based nasal spray supplemented with natural Symbiofilm® extract	–	Device: Healsea® Children, Other: Conventional therapies for common coldChildren will receive Healsea® Children nasal spray on top of conventional therapies for common cold, as needed.
Conventional therapies	–	Other: Conventional therapies for common coldChildren will receive conventional therapies for common cold as needed, nasal irrigation excluded

Who may qualify

Ages: 6 to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: The study population comprises children 6 to10 years old with perennial allergy and early symptoms of common cold. The recruitment will be competitive in both group, exposed to Healsea® Children or not exposed to Healsea® Children. However, when 100 patients will be recruited in one group, the recruitment will be stopped in this group but will continue in the other group until 100 patients to be enrolled.

Key inclusion criteria (8 listed)

Male/Female subjects ≥6 and ≤10-year-old
AsIgE (Allergy specific IgE) ≥ class 2 (RAST) or positive prick test for at least one perennial allergen
Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry
Patient presenting with fever ≥ 37.5 °C at screening
Symptoms of headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough, sneezing with a total score ≤9 (according to a physician-rated symptom score; scale: 0 to 3 [0: no symptom to 3: severe intensity])

Key exclusion criteria (10 listed)

Known hypersensitivity/allergy to any component of the test device
Medical history 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
History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores
Antibiotic intake within 2 weeks before screening

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® ChildrenAlso: Conventional therapies for common coldChildren will be administered Healsea Children , one puff (1-2 sec) in each nostril twice a day for 10 days on top of conventional therapies, as needed	Device	Healsea® Children: isotonic seawater based nasal spray supplemented with natural Symbiofilm® extract
Conventional therapies for common coldChildren will receive conventional therapies for common cold, nasal irrigation excluded (antipyretics, mucolytics, decongestants, antitussives, systemic and topical corticosteroids, antibiotics)	Other	Conventional therapies, Healsea® Children: isotonic seawater based nasal spray supplemented with natural Symbiofilm® extract

Primary outcome

AUC (Area Under Curve) of the Wisconsin Upper Respiratory Symptoms Survey for Kids (WURSS-K) During the 10-day Treatment Period
Time frame: Cumulative AUC of the WURSS score assessed from Day 1 to Day 10
The WURSS-K will be assessed once daily, from Day1 to Day10 (treatment period) WURSS-K is a 3-dimensional structure questionnaire specifically designed for children 4 to 10 years of age. It includes 6 items assessing symptoms (symptoms score: runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired), 7 items assessing functional impairments (quality of life score: think, sleep, breathe, talk, walk/climb stairs/exercise, go to school, play with friends), 1 item assessing global severity. All these items are scored from 0 (absent or no impairment) through 1 (a little bad), 2 (bad) and 3 (very bad). The AUC value of the WURSS-K during the 10 day- treatment period is comprised between 0 WURSS-K score*day (no impairement) and 420 WURSS-K score *day (maximal impairement)

8 secondary outcomes

Number of Days With Runny Nose
Time frame: Number of days with runny nose during the 10-day treatment period and a follow-up of 20 days, up to 30 days
Number of Days With Stuffy Nose
Time frame: Number of days with stuffy nose during the 10-day treatment period and a follow-up period of 20 days, up to 30 days
Number of Days With Sneezing
Time frame: Number of days with sneezing during the 10-day treatment period and a follow-up of 20 days, up to 30 days
Number of Days With Sore Throat
Time frame: Number of days with sore throat during the 10-day treatment period and a follow-up of 20 days, up to 30 days
Number of Days With Cough
Time frame: Number of days with cough during the 10-day treatment period and a follow-up of 20 days, up to 30 days
Number of Days With "Feeling Tired"
Time frame: Number of days with "feeling tired" during the 10-day treatment period and a follow-up of 20 days, up to 30 days
Respiratory Complication Requiring Antibiotic Prescription After the10-day Treatment Period
Time frame: Number of subjects with respiratory complications during the 20-day follow-up period
Number of Participants With Use of Concomitant Treatments
Time frame: During 10-day treatment period and a follow-up period of 20 days, up to 30 days

Results and safety

Results posted to the registry on 20 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract	101	100
Conventional Therapies	85	75

Primary outcome: AUC (Area Under Curve) of the Wisconsin Upper Respiratory Symptoms Survey for Kids (WURSS-K) During the 10-day Treatment Period

Time frame: Cumulative AUC of the WURSS score assessed from Day 1 to Day 10. Mean (Standard Deviation). Unit: scores on WURSS-K scale* days

Measure	Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract n = 101	Conventional Therapies n = 85
Value	36.56 (21.14)	55.54 (27.86)

Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract vs Conventional Therapies: p <0.05, Wilcoxon (Mann-Whitney)

Population analysed: All included subjects who used the investigational medical device at least once and with non-missing value at Day1 and at least another non-missing time point between Day2 and Day10. Otherwise, the AUC was missing.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected during a 10-day treatment period and a follow-up period of 20 days, up to 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract	0 of 101 (0%)	17 of 101 (16.8%)	0 of 101
Conventional Therapies	0 of 85 (0%)	23 of 85 (27.1%)	0 of 85

Limitations and caveats (from the sponsor): This is a not blinded, nor placebo-controlled investigation

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32077450Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600.
Background: PubMed 31295420Yan J, Bassler BL. Surviving as a Community: Antibiotic Tolerance and Persistence in Bacterial Biofilms. Cell Host Microbe. 2019 Jul 10;26(1):15-21. doi: 10.1016/j.chom.2019.06.002.
Background: PubMed 25875875Rabin N, Zheng Y, Opoku-Temeng C, Du Y, Bonsu E, Sintim HO. Biofilm formation mechanisms and targets for developing antibiofilm agents. Future Med Chem. 2015;7(4):493-512. doi: 10.4155/fmc.15.6.
Background: PubMed 32039733Varricchio A, La Mantia I, Brunese FP, Ciprandi G. Inflammation, infection, and allergy of upper airways: new insights from national and real-world studies. Ital J Pediatr. 2020 Feb 10;46(1):18. doi: 10.1186/s13052-020-0782-z.
Background: PubMed 16846459Ciprandi G, Tosca MA, Fasce L. Allergic children have more numerous and severe respiratory infections than non-allergic children. Pediatr Allergy Immunol. 2006 Aug;17(5):389-91. doi: 10.1111/j.1399-3038.2006.00413.x.
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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.

Andrzej EMERYK, MD, PhD principal investigator

University Children Hospital, Lublin, Poland

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Common Cold and Allergy, run by Lallemand Pharma AG at 15 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 8 inclusion and 10 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 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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?

Yes. Results are posted in the registry (first posted 20 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

AUC (Area Under Curve) of the Wisconsin Upper Respiratory Symptoms Survey for Kids (WURSS-K) During the 10-day Treatment Period (time frame: Cumulative AUC of the WURSS score assessed from Day 1 to Day 10). 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 NCT05034328, which also lists 9 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 20 Jan 2025.