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

Primary Purpose

Common Cold, Nasal Congestion

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
IP1 - Stérimar BLOCKED NOSE Baby nasal spray
IP2 - Stérimar Stop & Protect Cold Baby + standard of care
Standard of Care
Sponsored by
Church & Dwight Company, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Cold focused on measuring Common Cold, Nasal Congestion, Children

Eligibility Criteria

3 Months - 48 Months (Child)All SexesDoes not accept 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.

Sites / Locations

  • San Paolo HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Group A

Group B

Group C

Arm Description

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

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

Standard of Care alone

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 3, 2022
Last Updated
January 12, 2023
Sponsor
Church & Dwight Company, Inc.
Collaborators
Evidilya S.r.l.
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1. Study Identification

Unique Protocol Identification Number
NCT05244148
Brief Title
Two Seawater-based Formulations for Relief of Nasal Congestion in Paediatric Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Church & Dwight Company, Inc.
Collaborators
Evidilya S.r.l.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold, Nasal Congestion
Keywords
Common Cold, Nasal Congestion, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 Arms: Group A: IP1 - Stérimar BLOCKED NOSE Baby nasal spray + standard of care Group B: IP2 - Stérimar Stop & Protect Cold Baby + standard of care Group C: Standard of Care alone
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
IP1 - Stérimar BLOCKED NOSE Baby nasal spray + standard of care
Arm Title
Group B
Arm Type
Experimental
Arm Description
IP2 - Stérimar Stop & Protect Cold Baby + standard of care
Arm Title
Group C
Arm Type
Other
Arm Description
Standard of Care alone
Intervention Type
Device
Intervention Name(s)
IP1 - Stérimar BLOCKED NOSE Baby nasal spray
Intervention Description
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
Intervention Name(s)
IP2 - Stérimar Stop & Protect Cold Baby + standard of care
Intervention Description
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
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
hydration + rest at home + if needed paracetamol
Primary Outcome Measure Information:
Title
Change of nasal congestion.
Description
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.
Time Frame
Through study completion, an average of 10 days
Secondary Outcome Measure Information:
Title
Change of other cold symptoms.
Description
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.
Time Frame
Through study completion, an average of 10 days
Title
Occurrence of secondary infections.
Description
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.
Time Frame
Daily through the end of the study, approximately 10 days
Other Pre-specified Outcome Measures:
Title
Onset of relief.
Description
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.
Time Frame
Through study completion, an average of 10 days
Title
Concomitant medications.
Description
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.
Time Frame
Through study completion, an average of 10 days
Title
Frequency of paracetamol administration.
Description
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.
Time Frame
Through study completion, an average of 10 days
Title
Quality of sleep.
Description
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.
Time Frame
Through study completion, an average of 10 days
Title
Global assessment on common cold status.
Description
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.
Time Frame
Through study completion, an average of 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cesare Mutti
Phone
02 49530065
Email
cesare.mutti@evidilya.com
First Name & Middle Initial & Last Name or Official Title & Degree
Federica Pazzi
Phone
02 49530065
Email
federica.pazzi@evidilya.com
Facility Information:
Facility Name
San Paolo Hospital
City
Milan
ZIP/Postal Code
20142
Country
Italy
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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