Symbiofilm Trial in Allergic Kids (SYMBIOFILM-TAK)
Poland186 participantsStarted 2022-02-14
Plain-language 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.
Who can participate
Age range6 Years – 10 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
âś“. Written consent obtained from parent/legal guardians
âś“. Written assent obtained from patient
Exclusion criteria
âś•. Known hypersensitivity/allergy to any component of the test device
What they're measuring
1
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