Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms (NCT07262450) | Clinical Trial Compass
RecruitingNot Applicable
Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
France1,065 participantsStarted 2025-08-27
Plain-language summary
The purpose of this post-market clinical investigation is to assess in a real-life setting, the effectiveness, usage, tolerance, safety and satisfaction of 4 isotonic and hypertonic seawater-based CE-marked nasal sprays.
The main questions it aims to answer are:
* Efficacy,
* Safety,
* Usage,
* Satisfaction, in real-life usage among infants, children, adults and pregnant or breastfeeding women suffering from acute and chronic sinonasal pathologies. The 4 medical devices under investigation will be used in accordance with their intended use, target populations and medical indications.
Who can participate
Age range
15 Days
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:
* Subject's age and medical condition in compliance with the intended use and population
* Subjects who, from the investigator's judgement, should benefit from nasal wash in accordance with routine medical practice
* Subjects with at least two nasal symptoms of intensity ≥ 3 (6 modalities intensity SNOT-22 rating-scale) among the following:
* Nasal blockage/nasal congestion/ stuffy nose;
* Runny nose;
* Need to blow/clear the nose;
* Sneezing;
* Thick nasal discharge/secretions;
* Decreased sense of smell /taste (replaced by "noisy breathing/mouth breathing" for infants)
* Subjects with impaired nasal breathing (score ≥ 3, 6-modalities intensity rating-scale), induced by the presence of nasal symptoms
* For acute indications (only): subjects with symptoms started not later than 72 hours prior to enrolment (Day 0).
* For allergic rhinitis indication: perennial allergic rhinitis with and without seasonal allergic rhinitis
* For post-surgery indication: septoplasty and rhinoseptoplasty.
* Subject/parent willing to perform nasal wash following advices received from HCPs.
* Subjects (or parents for babies and children) agreeing to follow the study requirements during the whole study period (up to 3 months).
* Subject (or parent for baby and children) able to understand verbal and written local language and in capacity to fill-in questionnaire by himself.
* Subject having daily access to internet to answer online questionnaire.
* Subject or Parent/…
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
Real-life effectiveness to improve nasal symptoms in case of acute and chronic sinonasal pathologies.
Timeframe: From Day 0 to Day 5 (acute indications: URTI, COVID-19, bronchiolitis) From Day 0 to Day 14 (chronic indications: allergic rhinitis, chronic rhinosinusitis, post-surgery)