Symbiofilm Trial in Allergic Kids (SYMBIOFILM-TAK)

March 9, 2023 updated by: Lallemand Pharma AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  1. Male/Female subjects ≥6 and ≤10-year-old
  2. AsIgE (Allergy specific IgE) ≥ class 2 (RAST) or positive prick test for at least one perennial allergen
  3. Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry
  4. Patient presenting with fever ≥ 37.5 °C at screening
  5. 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])
  6. At least one of these symptoms: sore throat, runny nose or blocked nose (i.e., with a score ≥1)
  7. Written consent obtained from parent/legal guardians
  8. Written assent obtained from patient

Exclusion Criteria:

  1. Known hypersensitivity/allergy to any component of the test device
  2. Medical history that is considered by the investigator as a reason for non-inclusion,
  3. Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps
  4. History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores
  5. Antibiotic intake within 2 weeks before screening
  6. Systemic corticosteroids within 4 weeks before screening
  7. Antihistamines intake for allergy when treatment was started from less than 4 weeks
  8. Bacterial lysate intake within 6 months before screening
  9. Chronic decongestant use
  10. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Other Names:
  • Conventional therapies for common cold
Other: Conventional therapies for common cold
Children will receive conventional therapies for common cold, nasal irrigation excluded (antipyretics, mucolytics, decongestants, antitussives, systemic and topical corticosteroids, antibiotics)
Conventional therapies
Children will receive conventional therapies for common cold as needed, nasal irrigation excluded
Other: Conventional therapies for common cold
Children will receive conventional therapies for common cold, nasal irrigation excluded (antipyretics, mucolytics, decongestants, antitussives, systemic and topical corticosteroids, antibiotics)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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, in the evening, considering the symptoms from the morning to the evening, from Day1 to Day10 (treatment period)
Cumulative AUC of the WURSS score assessed from Day 1 to Day 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of common cold symptoms during the whole study: items 2 to 7 of WURSS-K
Time Frame: Number of days with cold symptoms during the intervention period (10-day treatment) and up to 30 days
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.
Number of days with cold symptoms during the intervention period (10-day treatment) and 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
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
Number of subjects with respiratory complications during the 20-day follow-up period
Use of concomitant treatments
Time Frame: During the intervention, up to 30 days
Frequency and number of days of use of concomitant treatments (conventional therapies) that may affect common cold symptoms (antibiotics, antipyretics, systemic or local mucolytics, decongestants, antitussives, systemic and topical corticosteroids) will be assessed in both groups and compared
During the intervention, up to 30 days
Spread of the common cold
Time Frame: During the intervention, up to 30 days
The number of family members in close contact developing common cold symptoms after the patient all over the study period
During the intervention, up to 30 days
Reporting of incidents, undesirable expected side effects and adverse events
Time Frame: During the intervention, up to 30 days
Assessment of adverse events, incidents, undesirable expected side effects during the intervention up to 30 in both groups
During the intervention, up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lallemand Pharma AG

Investigators

  • Principal Investigator: Andrzej EMERYK, MD, PhD, University Children Hospital, Lublin, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2022

Primary Completion (Actual)

November 3, 2022

Study Completion (Actual)

November 3, 2022

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPH-2101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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