Symbiofilm Trial in Allergic Kids (SYMBIOFILM-TAK)

NCT05034328 | Completed Results

• 1 other identifier: LPH-2101
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 15

Brief 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 nasal mucosa during common cold and rhinitis for children above 6 years. 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.

Conditions

Common Cold; Allergy

Keywords

Infectious rhinitis, nasal irrigation, perennial allergy

Outcome Measures

Primary Outcomes (1)

• 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)

  Cumulative AUC of the WURSS score assessed from Day 1 to Day 10

Secondary Outcomes (8)

• Number of Days With Runny Nose

  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

  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

  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

  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

  Number of days with cough during the 10-day treatment period and a follow-up of 20 days, up to 30 days

Study Arms (2)

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.

Device: Healsea® Children; Other: Conventional therapies for common cold

Conventional therapies

Children will receive conventional therapies for common cold as needed, nasal irrigation excluded

Other: Conventional therapies for common cold

Interventions

Healsea® Children DEVICE

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

Also known as: Conventional therapies for common cold

Healsea® Children: isotonic seawater based nasal spray supplemented with natural Symbiofilm® extract

Conventional therapies for common cold OTHER

Children will receive conventional therapies for common cold, nasal irrigation excluded (antipyretics, mucolytics, decongestants, antitussives, systemic and topical corticosteroids, antibiotics)

Conventional therapies; Healsea® Children: isotonic seawater based nasal spray supplemented with natural Symbiofilm® extract

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Known hypersensitivity/allergy to any component of the test device
• 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
• 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)

Sponsors & Collaborators

• Lallemand Pharma AG: lead

Study Sites (15)

Research Site

Bialystok, 15-010, Poland

Location

Research Site

Bialystok, 15-430, Poland

Location

Research Site

Bydgoszcz, 85-048, Poland

Location

Research Site

Dys, 21-003, Poland

Location

Research Site

Głowno, 95-015, Poland

Location

Research Site

Krakow, 30-644, Poland

Location

Research Site

Lublin, 20-093, Poland

Location

Research Site

Lublin, 20-141, Poland

Location

Research Site

Lublin, 20-552, Poland

Location

Research Site

Lublin, 20-803, Poland

Location

Research Site

Lublin, 20-865, Poland

Location

Research Site

Rzeszów, 35-061, Poland

Location

Research Site

Tarnów, 33-100, Poland

Location

Research Site

Warsaw, 04-314, Poland

Location

Research Site

Łomża, 18-402, Poland

Location

Related Publications (9)

• 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.

  PMID: 32077450 BACKGROUND

• 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.

  PMID: 31295420 BACKGROUND

• 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.

  PMID: 25875875 BACKGROUND

• 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.

  PMID: 32039733 BACKGROUND

• 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.

  PMID: 16846459 BACKGROUND

• 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.

  PMID: 17578494 BACKGROUND

• Eifan AO, Durham SR. Pathogenesis of rhinitis. Clin Exp Allergy. 2016 Sep;46(9):1139-51. doi: 10.1111/cea.12780.

  PMID: 27434218 BACKGROUND

• 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.

  PMID: 32889648 BACKGROUND

• 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.

  PMID: 30753196 BACKGROUND

MeSH Terms

Conditions

Common Cold; Hypersensitivity

Interventions

Cold Temperature

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Limitations and Caveats

This is a not blinded, nor placebo-controlled investigation

Results Point of Contact

• Title: Dr Bernard Gout
• Organization: Pharmndev Experts

bgout@pharmndev.ch

+41798659000

Study Officials

• Andrzej EMERYK, MD, PhD

  University Children Hospital, Lublin, Poland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 5, 2021
• Study Start: February 14, 2022
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: January 20, 2025
• Results First Posted: January 20, 2025

Record last verified: 2023-03

Locations

PL (15)