NCT05244148

Two Seawater-based Formulations for Relief of Nasal Congestion in Paediatric Subjects

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Church & Dwight Company, Inc. · Industry
• Sex: All
• Age: 3 Months – 48 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Common Cold
• Nasal Congestion

Interventions

Type	Name	Description
DEVICE	IP1 - Stérimar BLOCKED NOSE Baby nasal spray	1 to 2 sprays per nostril at least 2 twice a day and, as needed, up to a maximum of 6 times a day.
DEVICE	IP2 - Stérimar Stop & Protect Cold Baby + standard of care	1 to 2 sprays per nostril at least 2 twice a day and, as needed, up to a maximum of 6 times a day.
BEHAVIORAL	Standard of Care	hydration + rest at home + if needed paracetamol

Timeline

• Start date: 2021-11-25
• Primary completion: 2023-03-20
• Completion: 2023-03-20
• First posted: 2022-02-17
• Last updated: 2024-10-03

Locations

1 site across 1 country: Italy