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

Church & Dwight Company, Inc.1 site in 1 country9 target enrollmentNovember 25, 2021

ConditionsCommon Cold Nasal Congestion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Common Cold
Sponsor: Church & Dwight Company, Inc.
Enrollment: 9
Locations: 1
Primary Endpoint: Change of nasal congestion.
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 25, 2021

End Date

March 20, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Church & Dwight Company, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female infants and toddlers aged 3 - 48 months (inclusive) at enrolment (Day 0).
•Caretaker(s) answering "yes" to the question "Do you feel that your child has a cold?" at enrolment (Day 0).
•Subjects with symptoms started within 48 hours prior to enrolment (Day 0).
•Subjects with nasal congestion (blocked / stuffy nose) rated as at least grade 2 (moderately bothersome) on a 0 to 2-point scale, based on morning evaluation (within an hour of subject awakening).
•Subjects showing at least grade 2 on a 0 to 2-point scale for at least one of the following additional signs of cold symptoms: runny nose, nasal crust (dry mucus), thick mucus, sneezing and cough.
•Legal caretaker(s) signed written informed consent for their young ones to participate in the study.
•Legal caretaker(s) willing to comply with all study procedures.
•Ability of the caretaker(s) (in the Investigator's opinion) to comprehend the full nature, procedures, and purpose of the study.

Exclusion Criteria

•Subjects presenting a body temperature greater than 38°C measured with a non-contact infrared thermometer at enrolment (Day 0).
•Subjects presenting any secondary infection (such as bronchitis, otitis, tracheitis, pneumonia, and so on) at enrolment (Day 0).
•Subjects with positive results on a streptococcal antigen screening test (rapid antigen detection test or RADT) at enrolment (Day 0).
•Subjects with history of allergic rhinitis.
•Subjects presenting any congenital or chronic disease that in the opinion of the Investigator would adversely affect the results of the study (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, and so on).
•Subjects presenting any kind of immunodeficiency.
•Subjects presenting any hypersensitivity or allergy or intolerance to any component of the study products.
•Subjects with a positive medical history to any significant illness within the 2 weeks prior to the enrolment (Day 0).
•Subjects presenting any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.
•Subjects currently participating or having participated in another clinical trial during the last 30 days prior to enrolment (Day 0).

Outcomes

Primary Outcomes

Change of nasal congestion.

Time Frame: Through study completion, an average of 10 days

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.

Secondary Outcomes

Occurrence of secondary infections.(Daily through the end of the study, approximately 10 days)
Change of other cold symptoms.(Through study completion, an average of 10 days)