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

Church & Dwight

Status: Terminated

Conditions: Nasal Congestion; Common Cold

Treatments: Device: IP2 - Stérimar Stop & Protect Cold Baby + standard of care; Behavioral: Standard of Care; Device: IP1 - Stérimar BLOCKED NOSE Baby nasal spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT05244148

ST-20-F11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 3 to 48 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

Group A

Experimental group

Description:

IP1 - Stérimar BLOCKED NOSE Baby nasal spray + standard of care

Treatment:

Device: IP1 - Stérimar BLOCKED NOSE Baby nasal spray

Behavioral: Standard of Care

Group B

Experimental group

Description:

IP2 - Stérimar Stop \& Protect Cold Baby + standard of care

Treatment:

Behavioral: Standard of Care

Device: IP2 - Stérimar Stop & Protect Cold Baby + standard of care

Group C

Other group

Description:

Standard of Care alone

Treatment:

Behavioral: Standard of Care