A Nasal Spray for Relief of Nasal Congestion in Infants and Toddlers With Common Cold (NCT05365789) | Clinical Trial Compass
CompletedNot Applicable
A Nasal Spray for Relief of Nasal Congestion in Infants and Toddlers With Common Cold
Poland220 participantsStarted 2022-01-20
Plain-language 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.
Who can participate
Age range
3 Months – 48 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of nasal congestion
Timeframe: Through study completion, an average of 10 days.
. 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).