A Multicentre, Randomised, Open Label, Parallel Group, Controlled Clinical Trial to Evaluate Efficacy and Tolerability of Two Seawater-based Formulations Plus a Standard of Care Versus the Standard of Care Alone for Relief of Nasal Congestion in Paediatric Subjects With Common Cold
The objective of this clinical trial is to evaluate the tolerance and efficacy of two Stérimar nasal sprays products in children who have nasal congestion due to the common cold.
• Male and female infants and toddlers aged 3 - 48 months (inclusive) at enrolment (Day 0).
• Caretaker(s) answering yes to the question Do you feel that your child has a cold? at enrolment (Day 0).
• Subjects with symptoms started within 48 hours prior to enrolment (Day 0).
• Subjects with nasal congestion (blocked / stuffy nose) rated as at least grade 2 (moderately bothersome) on a 0 to 2-point scale, based on morning evaluation (within an hour of subject awakening).
• Subjects showing at least grade 2 on a 0 to 2-point scale for at least one of the following additional signs of cold symptoms: runny nose, nasal crust (dry mucus), thick mucus, sneezing and cough.
• Legal caretaker(s) signed written informed consent for their young ones to participate in the study.
• Legal caretaker(s) willing to comply with all study procedures.
• Ability of the caretaker(s) (in the Investigator's opinion) to comprehend the full nature, procedures, and purpose of the study.