A Trial to Evaluate Efficacy and Safety of a Nasal Spray Combined With Standard of Care for Nasal Congestion in Infants and Toddlers With Common Cold in Comparison to Standard of Care Alone
The study will evaluate the safety and efficacy of the study medical device plus standard of care versus standard of care in subjects between 3 and 48 months (inclusive) presenting symptoms of a common cold.
• Male and female infants and toddlers.
• Aged 3 - 48 months (inclusive) at enrolment (Day 0).
• Parent/legal guardian answering yes to the question Do you feel that your child has a cold? at enrolment.
• Subjects with symptoms started not later than 48 hours prior to enrolment (Day 0).
• Subjects with nasal congestion (blocked / stuffy nose) rated as at least score of 2 (moderately bothersome) on a 0 to 3-point scale, based on morning evaluation (within an hour of child awakening).
• Subjects showing at least one of the following additional signs of cold symptoms: runny nose, nasal crust (dry mucus), thick mucus, sneezing and cough.
• Parent/legal guardian of the subject has given freely and expressly her/his informed consent.
• Parent/legal guardian is cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol established by the clinical trial center could be expected.