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

October 2, 2024 updated by: Church & Dwight Company, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20142
        • San Paolo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 months to 4 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
IP1 - Stérimar BLOCKED NOSE Baby nasal spray + standard of care
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.
Behavioral: Standard of Care
hydration + rest at home + if needed paracetamol
Experimental: Group B
IP2 - Stérimar Stop & Protect Cold Baby + standard of care
Behavioral: Standard of Care
hydration + rest at home + if needed paracetamol
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.
Other: Group C
Standard of Care alone
Behavioral: Standard of Care
hydration + rest at home + if needed paracetamol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of nasal congestion.
Time Frame: Through study completion, an average of 10 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of other cold symptoms.
Time Frame: Through study completion, an average of 10 days

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
Occurrence of secondary infections.
Time Frame: Daily through the end of the study, approximately 10 days
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Onset of relief.
Time Frame: Through study completion, an average of 10 days
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
Concomitant medications.
Time Frame: Through study completion, an average of 10 days
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
Frequency of paracetamol administration.
Time Frame: Through study completion, an average of 10 days
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
Quality of sleep.
Time Frame: Through study completion, an average of 10 days
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
Global assessment on common cold status.
Time Frame: Through study completion, an average of 10 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Church & Dwight Company, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Evidilya S.r.l.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ST-20-F11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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