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.
The purpose of the present study is to test the efficacy, safety and tolerability of a product in relieving the symptoms of the common cold in children. This nasal spray is specifically studied for small children, classified as medical devices and is already on the market. Sterimar Blocked Nose Baby (CDEU048-28) nasal spray is a medical device and is a 100 ml bag-on-valve spray. The spray contains hypertonic solution based on 100% natural sea water rich of marine trace elements with added manganese and copper. 220 subjects will be included in this open label, randomized, parallel group, study product and standard of care versus standard of care study. Study product will be used as 1 to 2 sprays per nostril (each "dose" is 1 or 2 sprays per nostril, the second spray only if needed), for a minimum of 2 times (morning and evening) and, as needed, up to a maximum of 6 times per day (i.e., maximum 12 sprays per nostril each day). The 10 day study consists of 4 visits- Day 0 onsite, Days 3 and 6 telephone contact, and Day 10 onsite. There will be 3 strata according to age: (3-12 months), (13-24 months) and (25-48 months). Every effort will be made to ensure at least 20% of subjects in each of the study groups are 3-12 months of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
One or two nasal sprays will be administered to each nostril for a minimum of 2 times per day up to a maximum of 6 times per day for a maximum of 10 days.
Standard of care consists of hydration, rest at home and antipyretic paracetamol as necessary.
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Change of nasal congestion
Assess reduction of nasal congestion, evaluated by means of a specific questionnaire ("Cold Symptom Severity Questionnaire") on a 0 to 3-point scale, with higher score indicating a worse outcome, with 0 =not at all, 1=mild, 2=moderate and 3=severe to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons between groups.
Time frame: Through study completion, an average of 10 days.
Change of other cold symptoms
Assess change of other cold symptoms, evaluated by means of a specific questionnaire ("Cold Symptom Severity Questionnaire"),on a 0 to 3-point scale, with higher score indicating a worse outcome, with 0=not at all, 1=mild, 2=moderate and 3=severe, to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons between groups. Other cold symptoms: Stuffy nose, Nasal crust, Runny nose, Thick mucus, Sneezing, Cough
Time frame: Through study completion, an average of 10 days.
Occurrence of secondary infections
Assessment of occurrence of secondary infections (number) daily, from the beginning to the end of the study; comparison between groups. Secondary infections will be confirmed by the Investigator.
Time frame: Through study completion, an average of 10 days.
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