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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Common Cold, Nasal Congestion

Intervention / Treatment
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* Device: IP1 - Stérimar BLOCKED NOSE Baby nasal spray
* Device: IP2 - Stérimar Stop & Protect Cold Baby + standard of care
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 48 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>IP1 - Stérimar BLOCKED NOSE Baby nasal spray + standard of care | Device: IP1 - Stérimar BLOCKED NOSE Baby nasal spray<br>* 1 to 2 sprays per nostril at least 2 twice a day and, as needed, up to a maximum of 6 times a day.<br>Behavioral: Standard of Care<br>* hydration + rest at home + if needed paracetamol<br>|
| Experimental: Group B<br>IP2 - Stérimar Stop & Protect Cold Baby + standard of care | Device: IP2 - Stérimar Stop & Protect Cold Baby + standard of care<br>* 1 to 2 sprays per nostril at least 2 twice a day and, as needed, up to a maximum of 6 times a day.<br>Behavioral: Standard of Care<br>* hydration + rest at home + if needed paracetamol<br>|
| Other: Group C<br>Standard of Care alone | Behavioral: Standard of Care<br>* hydration + rest at home + if needed paracetamol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Common Cold, Nasal Congestion, Children