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

Common Cold Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05244148
• Other study ID #: ST-20-F11
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: January 2023
• Source: Church & Dwight Company, Inc.
• Contact: Cesare Mutti
• Phone: 02 49530065
• Email: cesare.mutti[@]evidilya.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 48 Months

Eligibility

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.

Related Conditions & MeSH terms

• Common Cold
• Nasal Congestion

Intervention

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.
• 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.

Behavioral:
• Standard of Care
hydration + rest at home + if needed paracetamol

Locations

Country	Name	City	State
Italy	San Paolo Hospital	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Church & Dwight Company, Inc.	Evidilya S.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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