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.
• 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