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

NCT05244148 | Terminated

• 1 other identifier: ST-20-F11
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Cold; Nasal Congestion

Keywords

Common Cold; Nasal Congestion; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change of other cold symptoms.

  Through study completion, an average of 10 days

• Occurrence of secondary infections.

  Daily through the end of the study, approximately 10 days

Other Outcomes (5)

• Onset of relief.

  Through study completion, an average of 10 days

• Concomitant medications.

  Through study completion, an average of 10 days

• Frequency of paracetamol administration.

  Through study completion, an average of 10 days

Study Arms (3)

Group A

EXPERIMENTAL

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

Device: IP1 - Stérimar BLOCKED NOSE Baby nasal spray; Behavioral: Standard of Care

Group B

EXPERIMENTAL

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

Device: IP2 - Stérimar Stop & Protect Cold Baby + standard of care; Behavioral: Standard of Care

Group C

OTHER

Standard of Care alone

Behavioral: Standard of Care

Interventions

IP1 - Stérimar BLOCKED NOSE Baby nasal spray 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.

Group A

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

Group B

Standard of Care BEHAVIORAL

hydration + rest at home + if needed paracetamol

Group A; Group B; Group C

Eligibility Criteria

• Age: 3 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead
• Evidilya S.r.l.: collaborator

Study Sites (1)

San Paolo Hospital

Milan, 20142, Italy

Location

MeSH Terms

Conditions

Common Cold; Nasal Obstruction

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3 Arms: 1. Group A: IP1 - Stérimar BLOCKED NOSE Baby nasal spray + standard of care 2. Group B: IP2 - Stérimar Stop \& Protect Cold Baby + standard of care 3. Group C: Standard of Care alone

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 17, 2022
• Study Start: November 25, 2021
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

IT (1)