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

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.

Study Overview

• Status: Terminated
• Conditions: Nasal Congestion; Common Cold
• Intervention / Treatment: Device: IP1 - Stérimar BLOCKED NOSE Baby nasal spray; Behavioral: Standard of Care; Device: IP2 - Stérimar Stop & Protect Cold Baby + standard of care

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20142
    • San Paolo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 4 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and female infants and toddlers aged 3 - 48 months (inclusive) at enrolment (Day 0).
2. Caretaker(s) answering "yes" to the question "Do you feel that your child has a cold?" at enrolment (Day 0).
3. Subjects with symptoms started within 48 hours prior to enrolment (Day 0).
4. 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).
5. 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.
6. Legal caretaker(s) signed written informed consent for their young ones to participate in the study.
7. Legal caretaker(s) willing to comply with all study procedures.
8. Ability of the caretaker(s) (in the Investigator's opinion) to comprehend the full nature, procedures, and purpose of the study.

Exclusion Criteria:

1. Subjects presenting a body temperature greater than 38°C measured with a non-contact infrared thermometer at enrolment (Day 0).
2. Subjects presenting any secondary infection (such as bronchitis, otitis, tracheitis, pneumonia, and so on) at enrolment (Day 0).
3. Subjects with positive results on a streptococcal antigen screening test (rapid antigen detection test or RADT) at enrolment (Day 0).
4. Subjects with history of allergic rhinitis.
5. 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).
6. Subjects presenting any kind of immunodeficiency.
7. Subjects presenting any hypersensitivity or allergy or intolerance to any component of the study products.
8. Subjects with a positive medical history to any significant illness within the 2 weeks prior to the enrolment (Day 0).
9. Subjects presenting any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.
10. Subjects currently participating or having participated in another clinical trial during the last 30 days prior to enrolment (Day 0).
11. Subjects using saline nose drops or nasal sprays or pumps other than the study products, antibiotics, antivirals, intranasal medicines, decongestants, antihistamines, echinacea, combination cold formulas, supplements containing ≥ 10 mg zinc that would influence symptoms scores at enrolment (Day 0) within 12 hours prior the day of screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; IP1 - Stérimar BLOCKED NOSE Baby nasal spray + standard of care	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.; Behavioral: Standard of Care; hydration + rest at home + if needed paracetamol
Experimental: Group B; IP2 - Stérimar Stop & Protect Cold Baby + standard of care	Behavioral: Standard of Care; hydration + rest at home + if needed paracetamol; 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.
Other: Group C; Standard of Care alone	Behavioral: Standard of Care; hydration + rest at home + if needed paracetamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, an average of 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Daily through the end of the study, approximately 10 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of relief.	Assessment of onset of relief (immediate relief) after the entire product application is completed (1 or 2 sprays) at Day 0 (baseline) and daily from Day 1 to Day 3 of the study; comparisons within groups A and B.	Through study completion, an average of 10 days
Concomitant medications.	Assessment of use of concomitant medications (frequency, excluding paracetamol) will be done from the beginning to the end of the study; comparisons among groups A, B, C.	Through study completion, an average of 10 days
Frequency of paracetamol administration.	Assessment of use of paracetamol (frequency) will be done from the beginning to the end of the study; comparisons within groups A, B, versus group C.	Through study completion, an average of 10 days
Quality of sleep.	Assessment of quality of sleep will be evaluated by means of the "quality of sleep" questionnaire, to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons within groups A, B versus group C.	Through study completion, an average of 10 days
Global assessment on common cold status.	Global assessment on common cold status will be evaluated by means of the "global assessment on common cold status" questionnaire, to be completed from the beginning to the end of the study; comparisons within groups.	Through study completion, an average of 10 days

Collaborators and Investigators

• Sponsor: Church & Dwight Company, Inc.
• Collaborators: Evidilya S.r.l.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2021
• Primary Completion (Actual): March 20, 2023
• Study Completion (Actual): March 20, 2023

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Children; Common Cold; Nasal Congestion
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold
• Other Study ID Numbers: ST-20-F11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No