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.
This clinical trial is a multicentre, randomized, parallel-group, controlled, open-label clinical trial to evaluate the efficacy of two Stérimar nasal sprays formulations (medical device already CE marked) for nasal congestion in children aged 3 to 48 months with common cold. In total the study foresees 300 patients divided between the different clinical sites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
1 to 2 sprays per nostril at least 2 twice a day and, as needed, up to a maximum of 6 times a day.
1 to 2 sprays per nostril at least 2 twice a day and, as needed, up to a maximum of 6 times a day.
hydration + rest at home + if needed paracetamol
San Paolo Hospital
Milan, Italy
Change of nasal congestion.
Assess change of nasal congestion, evaluated by means of a specific questionnaire ("Cold Symptom Severity" questionnaire), to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons among groups A, B versus group C.
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), to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons among groups; comparisons among groups A, B versus group C. Other cold symptoms: * Nasal crust (dry mucus) * Runny nose (drip/sniff/snorting/drainage/discharge) * 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; comparisons of group A, B versus group C. Secondary infections will be confirmed by the Investigator.
Time frame: Daily through the end of the study, approximately 10 days
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