Clinical trial NCT05244148: 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
Overall status: TERMINATED
Phase: NA
Conditions: Common Cold
Nasal Congestion
Keywords: Common Cold
Nasal Congestion
Children
Lead sponsor: Church & Dwight Company, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Evidilya S.r.l.
First posted: 2022-02-17
Enrollment: 9
Sex: ALL
Minimum age (years): 3
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 Arms:

1. Group A: IP1 - Stérimar BLOCKED NOSE Baby nasal spray + standard of care
2. Group B: IP2 - Stérimar Stop \& Protect Cold Baby + standard of care
3. Group C: Standard of Care alone
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of nasal congestion.
timeFrame: Through study completion, an average of 10 days
Secondary outcomes:
measure: Change of other cold symptoms.
timeFrame: Through study completion, an average of 10 days
measure: Occurrence of secondary infections.
timeFrame: Daily through the end of the study, approximately 10 days
Other outcomes:
measure: Onset of relief.
timeFrame: Through study completion, an average of 10 days
measure: Concomitant medications.
timeFrame: Through study completion, an average of 10 days
measure: Frequency of paracetamol administration.
timeFrame: Through study completion, an average of 10 days
measure: Quality of sleep.
timeFrame: Through study completion, an average of 10 days
measure: Global assessment on common cold status.
timeFrame: Through study completion, an average of 10 days
Locations:
city: Milan
country: Italy
facility: San Paolo Hospital
Study officials:
References: