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

NCT05365789 | Completed

• 1 other identifier: ST-21-U58
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Congestion

Keywords

Pediatric

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 10 days.

Secondary Outcomes (2)

• Change of other cold symptoms

  Through study completion, an average of 10 days.

• Occurrence of secondary infections

  Through study completion, an average of 10 days.

Other Outcomes (5)

• Onset of relief

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

• Concomitant medications

  Through study completion, an average of 10 days.

• Frequency of paracetamol administration.

  Through study completion, an average of 10 days.

Study Arms (2)

Study Device and Standard of Care

ACTIVE COMPARATOR

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.

Device: Blocked Nose Baby nasal spray; Other: Standard of care

Standard of Care

OTHER

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

Other: Standard of care

Interventions

Blocked Nose Baby nasal spray DEVICE

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.

Study Device and Standard of Care

Standard of care OTHER

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

Standard of Care; Study Device and Standard of Care

Eligibility Criteria

• Age: 3 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead

Study Sites (1)

PRIVATE PRACTICE ul. Osiedle Sierakowskich 5

Sztum, 82-400, Poland

Location

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Anna Rynkiewicz, MD

  Private Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: May 9, 2022
• Study Start: January 20, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

PL (1)