Observational Study of RHINOSEDAL in Acute Nasal Obstruction (NCT07620522) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Observational Study of RHINOSEDAL in Acute Nasal Obstruction
France126 participantsStarted 2026-10-15
Plain-language summary
This prospective, multicenter, national, observational, non-interventional post-market clinical follow-up study evaluates the performance and safety of RHINOSEDAL in children and adults presenting with acute nasal obstruction associated with common cold, allergic or non-allergic rhinitis, or rhinosinusitis. Patients prescribed RHINOSEDAL in routine care will be followed for 6 ±1 days using patient-reported outcome measures including the NOSE score.
Who can participate
Age range
8 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:
* Age 8 years or older.
* Acute nasal obstruction evolving for less than 48 hours associated with common cold, allergic or non-allergic rhinitis, or rhinosinusitis.
* Baseline NOSE score \>40/100.
* No warning signs such as pus, unilateral obstruction, bleeding, or pain.
* RHINOSEDAL prescribed by the investigator.
* Written informed consent signed.
* Affiliated with a health insurance system.
Exclusion Criteria:
* Known anatomical cause of chronic nasal congestion.
* Corticosteroid use within the previous 2 days.
* NSAID use within the previous 2 days.
* Sympathomimetic use within the previous 2 days.
* Nasal decongestant or nasal irrigation within the previous 2 days.
* Antihistamines unless stable for more than 48 hours and maintained.
* Contraindication listed in the RHINOSEDAL instructions for use.
* Patient under legal protection.
* Pregnant or breastfeeding women.
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.