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

NCT ID: NCT05244148

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-25
• Study Completion Date: 2023-03-20

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.

Conditions

Common Cold; Nasal Congestion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

IP1 - Stérimar BLOCKED NOSE Baby nasal spray

Intervention Type: DEVICE

1 to 2 sprays per nostril at least 2 twice a day and, as needed, up to a maximum of 6 times a day.

Standard of Care

Intervention Type: BEHAVIORAL

hydration + rest at home + if needed paracetamol

Group B

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

1 to 2 sprays per nostril at least 2 twice a day and, as needed, up to a maximum of 6 times a day.

Standard of Care

Intervention Type: BEHAVIORAL

hydration + rest at home + if needed paracetamol

Group C

Standard of Care alone

Group Type: OTHER

Standard of Care

Intervention Type: BEHAVIORAL

hydration + rest at home + if needed paracetamol

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Standard of Care

hydration + rest at home + if needed paracetamol

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 48 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evidilya S.r.l.

INDUSTRY

Sponsor Role: collaborator

Church & Dwight Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

San Paolo Hospital

Milan, , Italy

Countries

Italy

Other Identifiers

ST-20-F11

Identifier Type: -

Identifier Source: org_study_id