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

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    220
  • sponsor
    Church & Dwight Company, Inc.
Updated on 30 May 2022
Accepts healthy volunteers

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.

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.

Details
Condition Nasal Congestion
Treatment Standard of Care, Blocked Nose Baby nasal spray
Clinical Study IdentifierNCT05365789
SponsorChurch & Dwight Company, Inc.
Last Modified on30 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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