Symbiofilm Trial in Allergic Kids (SYMBIOFILM-TAK)

Launched by LALLEMAND PHARMA AG · Sep 2, 2021

Keywords

ClinConnect Summary

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, inv...

Gender

ALL

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)