Symbiofilm Trial in Allergic Kids (SYMBIOFILM-TAK)

Completed

Conditions: Common Cold
Allergy

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

Registration Number: NCT05034328

Lead Sponsor: Lallemand Pharma AG

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 186

Inclusion Criteria

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

Exclusion Criteria

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
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)

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healsea® Children: isotonic seawater based nasal spray supplemented with natural Symbiofilm® extract	Conventional therapies for common cold	Children will receive Healsea® Children nasal spray on top of conventional therapies for common cold, as needed.
Healsea® Children: isotonic seawater based nasal spray supplemented with natural Symbiofilm® extract	Healsea® Children	Children will receive Healsea® Children nasal spray on top of conventional therapies for common cold, as needed.
Conventional therapies	Conventional therapies for common cold	Children will receive conventional therapies for common cold as needed, nasal irrigation excluded

Primary Outcome Measures

Name	Time	Method
AUC (Area Under Curve) of the Wisconsin Upper Respiratory Symptoms Survey for Kids (WURSS-K) During the 10-day Treatment Period	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)

Secondary Outcome Measures

Name	Time	Method
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	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
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	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.
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	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.
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	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.
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	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.
Number of Days With "Feeling Tired"	Number of days with "feeling tired" during the 10-day treatment period and a follow-up of 20 days, 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 each common cold symptoms in both groups. Feeling tired is the item 7.
Respiratory Complication Requiring Antibiotic Prescription After the10-day Treatment Period	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 Participants With Use of Concomitant Treatments	During 10-day treatment period and a follow-up period of 20 days, up to 30 days	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