NCT05365789

A Nasal Spray for Relief of Nasal Congestion in Infants and Toddlers With Common Cold

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Church & Dwight Company, Inc. · Industry
• Sex: All
• Age: 3 Months – 48 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Nasal Congestion

Interventions

Type	Name	Description
DEVICE	Blocked Nose Baby nasal spray	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.
OTHER	Standard of care	Standard of care consists of hydration, rest at home and antipyretic paracetamol as necessary.

Timeline

• Start date: 2022-01-20
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2022-05-09
• Last updated: 2023-10-26

Locations

1 site across 1 country: Poland