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

Not Applicable

Terminated

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

• Registration Number: NCT05244148
• Lead Sponsor: Church & Dwight Company, Inc.

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.

Study Timeline

• Study Start: 2021-11-25
• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-17
• Primary Completion: 2023-03-20
• Study Completion: 2023-03-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Standard of Care	IP1 - Stérimar BLOCKED NOSE Baby nasal spray + standard of care
Group C	Standard of Care	Standard of Care alone
Group B	Standard of Care	IP2 - Stérimar Stop \& Protect Cold Baby + standard of care
Group B	IP2 - Stérimar Stop & Protect Cold Baby + standard of care	IP2 - Stérimar Stop \& Protect Cold Baby + standard of care
Group A	IP1 - Stérimar BLOCKED NOSE Baby nasal spray	IP1 - Stérimar BLOCKED NOSE Baby nasal spray + standard of care

Primary Outcome Measures

Name	Time	Method
Change of nasal congestion.	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 Outcome Measures

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

Trial Locations

Locations (1)

San Paolo Hospital; 🇮🇹 Milan, Italy