Clinical trial NCT05034328: Symbiofilm Trial in Allergic Kids (SYMBIOFILM-TAK)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Common Cold
Allergy
Keywords: Infectious rhinitis, nasal irrigation, perennial allergy
Lead sponsor: Lallemand Pharma AG
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 186
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: AUC (Area Under Curve) of the Wisconsin Upper Respiratory Symptoms Survey for Kids (WURSS-K) During the 10-day Treatment Period
timeFrame: Cumulative AUC of the WURSS score assessed from Day 1 to Day 10
Secondary outcomes:
measure: Number of Days With Runny Nose
timeFrame: Number of days with runny nose during the 10-day treatment period and a follow-up of 20 days, up to 30 days
measure: Number of Days With Stuffy Nose
timeFrame: Number of days with stuffy nose during the 10-day treatment period and a follow-up period of 20 days, up to 30 days
measure: Number of Days With Sneezing
timeFrame: Number of days with sneezing during the 10-day treatment period and a follow-up of 20 days, up to 30 days
measure: Number of Days With Sore Throat
timeFrame: Number of days with sore throat during the 10-day treatment period and a follow-up of 20 days, up to 30 days
measure: Number of Days With Cough
timeFrame: Number of days with cough during the 10-day treatment period and a follow-up of 20 days, up to 30 days
measure: Number of Days With "Feeling Tired"
timeFrame: Number of days with "feeling tired" during the 10-day treatment period and a follow-up of 20 days, up to 30 days
measure: Respiratory Complication Requiring Antibiotic Prescription After the10-day Treatment Period
timeFrame: Number of subjects with respiratory complications during the 20-day follow-up period
measure: Number of Participants With Use of Concomitant Treatments
timeFrame: During 10-day treatment period and a follow-up period of 20 days, up to 30 days
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Dys
country: Poland
facility: Research Site
city: Głowno
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Rzeszów
country: Poland
facility: Research Site
city: Tarnów
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Łomża
country: Poland
facility: Research Site
Study officials:
affiliation: University Children Hospital, Lublin, Poland
name: Andrzej EMERYK, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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