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A Nasal Spray for Relief of Nasal Congestion in Infants and Toddlers With Common Cold

Primary Purpose

Nasal Congestion

Status

Recruiting

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Blocked Nose Baby nasal spray

Standard of care

About this trial

This is an interventional treatment trial for Nasal Congestion focused on measuring Pediatric

Eligibility Criteria

3 Months - 48 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male and female infants and toddlers.
Aged 3 - 48 months (inclusive) at enrolment (Day 0).
Parent/legal guardian answering "yes" to the question "Do you feel that your child has a cold?" at enrolment.
Subjects with symptoms started not later than 48 hours prior to enrolment (Day 0).
Subjects with nasal congestion (blocked / stuffy nose) rated as at least score of 2 (moderately bothersome) on a 0 to 3-point scale, based on morning evaluation (within an hour of child awakening).
Subjects showing at least one of the following additional signs of cold symptoms: runny nose, nasal crust (dry mucus), thick mucus, sneezing and cough.
Parent/legal guardian of the subject has given freely and expressly her/his informed consent.
Parent/legal guardian is cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol established by the clinical trial center could be expected.

Exclusion Criteria:

Subjects presenting an oral temperature greater than 38°C at enrolment (Day 0).
Subjects presenting any secondary infection (such as bronchitis, otitis, tracheitis, pneumonia, etc.) at enrolment (Day 0).
Subjects with positive results on a streptococcal antigen screening test (rapid antigen detection test or RADT) at inclusion.
Subjects with a 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, etc).
Subjects presenting any kind of immunodeficiency.
Subjects presenting any hypersensitivity or allergy or intolerance to any component of the study products or of the rescue medication (paracetamol)
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
Subject who was abroad in a country with a higher incidence rate of Covid-19 than Poland, within 14 days before the beginning of the study.
Subject who have had contact with any person infected with COVID-19 within 10 days before the beginning of the study.
Subject who are currently home quarantined, as recommended by the Sanitary Inspection.

Sites / Locations

PRIVATE PRACTICE ul. Osiedle Sierakowskich 5Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Study Device and Standard of Care

Standard of Care

Arm Description

1 to 2 sprays per nostril of Sterimar Blocked Nose Baby for a minimum of 2 times (morning and evening) and, as needed, up to a maximum of 6 times per day (i.e. maximum 12 sprays per nostril each day) until nasal symptoms are resolved, up to a maximum of 10 days. Standard of care consists of hydration, rest at home and antipyretic paracetamol as necessary.

Standard of care consists of hydration, rest at home and antipyretic medication paracetamol as necessary.

Outcomes

Primary Outcome Measures

Change of nasal congestion

Assess reduction of nasal congestion, evaluated by means of a specific questionnaire ("Cold Symptom Severity Questionnaire") on a 0 to 3-point scale, with higher score indicating a worse outcome, with 0 =not at all, 1=mild, 2=moderate and 3=severe to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons between groups.

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"),on a 0 to 3-point scale, with higher score indicating a worse outcome, with 0=not at all, 1=mild, 2=moderate and 3=severe, to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons between groups. Other cold symptoms: Stuffy nose, Nasal crust, Runny nose, 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; comparison between groups. Secondary infections will be confirmed by the Investigator.

Full Information

NCT ID

NCT05365789

First Posted

January 27, 2022

Last Updated

May 9, 2022

Sponsor

Church & Dwight Company, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05365789

Brief Title

A Nasal Spray for Relief of Nasal Congestion in Infants and Toddlers With Common Cold

Official Title

A Trial to Evaluate Efficacy and Safety of a Nasal Spray Combined With Standard of Care for Nasal Congestion in Infants and Toddlers With Common Cold in Comparison to Standard of Care Alone

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 20, 2022 (Actual)

Primary Completion Date

March 31, 2023 (Anticipated)

Study Completion Date

May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Church & Dwight Company, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study will evaluate the safety and efficacy of the study medical device plus standard of care versus standard of care in subjects between 3 and 48 months (inclusive) presenting symptoms of a common cold.

Detailed Description

The purpose of the present study is to test the efficacy, safety and tolerability of a product in relieving the symptoms of the common cold in children. This nasal spray is specifically studied for small children, classified as medical devices and is already on the market. Sterimar Blocked Nose Baby (CDEU048-28) nasal spray is a medical device and is a 100 ml bag-on-valve spray. The spray contains hypertonic solution based on 100% natural sea water rich of marine trace elements with added manganese and copper. 220 subjects will be included in this open label, randomized, parallel group, study product and standard of care versus standard of care study. Study product will be used as 1 to 2 sprays per nostril (each "dose" is 1 or 2 sprays per nostril, the second spray only if needed), for a minimum of 2 times (morning and evening) and, as needed, up to a maximum of 6 times per day (i.e., maximum 12 sprays per nostril each day). The 10 day study consists of 4 visits- Day 0 onsite, Days 3 and 6 telephone contact, and Day 10 onsite. There will be 3 strata according to age: (3-12 months), (13-24 months) and (25-48 months). Every effort will be made to ensure at least 20% of subjects in each of the study groups are 3-12 months of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasal Congestion

Keywords

Pediatric

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Open label, randomized, parallel group. Study product and standard of care versus standard of care.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study Device and Standard of Care

Arm Type

Active Comparator

Arm Description

Arm Title

Standard of Care

Arm Type

Other

Arm Description

Standard of care consists of hydration, rest at home and antipyretic medication paracetamol as necessary.

Intervention Type

Device

Intervention Name(s)

Blocked Nose Baby nasal spray

Intervention Description

One or two nasal sprays will be administered to each nostril for a minimum of 2 times per day up to a maximum of 6 times per day for a maximum of 10 days.

Intervention Type

Other

Intervention Name(s)

Standard of care

Intervention Description

Standard of care consists of hydration, rest at home and antipyretic paracetamol as necessary.

Primary Outcome Measure Information:

Title

Change of nasal congestion

Description

Time Frame

Through study completion, an average of 10 days.

Secondary Outcome Measure Information:

Title

Change of other cold symptoms

Description

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; comparison between groups. Secondary infections will be confirmed by the Investigator.

Time Frame

Through study completion, an average of 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; within investigational device group. the study.

Time Frame

assessed at 5, 15, and 30 minutes post first application of device every morning from Day 0 to 3

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 between groups.

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 between groups.

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 a questionnaire ("Quality of Sleep Questionnaire"), on a 0 to 3-point scale, with higher score indicating a worse outcome, with 0=not at all, 1=slightly, 2=moderately and 3=severely, to be completed from Day 0 (baseline) and daily from the beginning to the end of the study; comparisons between groups.

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", on a 0 to 3-point scale, with higher score indicating a better outcome, with 0=no relief at all, 1=slight relief, 2=moderate relief and 3=complete relief, to be completed from the beginning to the end of the study; comparisons between 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

Eligibility Criteria

Inclusion Criteria: Male and female infants and toddlers. Aged 3 - 48 months (inclusive) at enrolment (Day 0). Parent/legal guardian answering "yes" to the question "Do you feel that your child has a cold?" at enrolment. Subjects with symptoms started not later than 48 hours prior to enrolment (Day 0). Subjects with nasal congestion (blocked / stuffy nose) rated as at least score of 2 (moderately bothersome) on a 0 to 3-point scale, based on morning evaluation (within an hour of child awakening). Subjects showing at least one of the following additional signs of cold symptoms: runny nose, nasal crust (dry mucus), thick mucus, sneezing and cough. Parent/legal guardian of the subject has given freely and expressly her/his informed consent. Parent/legal guardian is cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol established by the clinical trial center could be expected. Exclusion Criteria: Subjects presenting an oral temperature greater than 38°C at enrolment (Day 0). Subjects presenting any secondary infection (such as bronchitis, otitis, tracheitis, pneumonia, etc.) at enrolment (Day 0). Subjects with positive results on a streptococcal antigen screening test (rapid antigen detection test or RADT) at inclusion. Subjects with a 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, etc). Subjects presenting any kind of immunodeficiency. Subjects presenting any hypersensitivity or allergy or intolerance to any component of the study products or of the rescue medication (paracetamol) 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 Subject who was abroad in a country with a higher incidence rate of Covid-19 than Poland, within 14 days before the beginning of the study. Subject who have had contact with any person infected with COVID-19 within 10 days before the beginning of the study. Subject who are currently home quarantined, as recommended by the Sanitary Inspection.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Oliver Chen, PhD

Phone

+1 609 806 1884

oliver.chen@churchdwight.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Rynkiewicz, MD

Organizational Affiliation

Private Practice

Official's Role

Principal Investigator

Facility Information:

Facility Name

PRIVATE PRACTICE ul. Osiedle Sierakowskich 5

City

Sztum

ZIP/Postal Code

82-400

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna RYNKIEWICZ, MD

Phone

48 604532564

ranna10@wp.pl

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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A Nasal Spray for Relief of Nasal Congestion in Infants and Toddlers With Common Cold

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