Evaluate the Effect of Nasal Spray in the Prevention of RTI in Children With Pre-school Wheezing (NCT05684848) | Clinical Trial Compass
UnknownNot Applicable
Evaluate the Effect of Nasal Spray in the Prevention of RTI in Children With Pre-school Wheezing
Italy252 participantsStarted 2022-11-01
Plain-language summary
To determine whether or not preventive administration of resveratrol in the form of a nasal spray is effective in reducing the number of asthma exacerbations typical of preschool wheezing children who develop viral infections.
Who can participate
Age range
3 Years – 6 Years
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.
Inclusion Criteria:
* Children diagnosed with wheezing
* Patients aged between 3 and 6 years (inclusive) at the time of enrollment of both genders
* Signature of the informed consent
* Availability of a mobile phone capable of installing VIR@PP
Exclusion Criteria:
* Inability to adequately understand the Italian language
* Presence of autoimmune pathologies, immunodeficiency, neuromuscular diseases, congenital cardiomyopathies, metabolic diseases
* Presence of other syndromes and genetic pathologies
* Patients on therapy with other drugs (steroids for topical and/or oral use)
* Abnormalities of the nose or other conditions (e.g. severe hypotonia etc…) which make the administration of a nasal spray impossible or unsafe
* Denial of informed consent
* Participation in other clinical studies
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 the number of days with respiratory symptoms compared to placebo