[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637983":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":37,"collaborators":39,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":17,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":10,"enrollmentInfo":51,"targetDuration":10,"studyType":54,"phases":10,"briefSummary":55,"conditions":56,"keywords":62,"overallStatus":73,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Laboratoires Elerte","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients treated with RHINOSEDAL",null,"Children and adults aged 8 years or older consulting a general practitioner for acute nasal obstruction associated with common cold, rhinitis, or rhinosinusitis and prescribed RHINOSEDAL in routine care.",[13],"Device: RHINOSEDAL",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","RHINOSEDAL","RHINOSEDAL is a ready-to-use hypertonic nasal spray containing natural sea water, tamarind extract and mallow extract. It acts mechanically through osmotic decongestion and cleansing of the upper airways. It is used according to the instructions for use and physician prescription.",[9],[21],{"name":22,"affiliation":23,"role":24},"Pascal DEMOLY, MD, PhD","University hospital of Montpellier, FRANCE","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Renaud URBINELLI","CONTACT","+33756882093","etudes@clin-experts.fr",[32],{"facility":33,"status":10,"city":34,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Multiples facilities","Multiple Locations","France","FR",{"type":38,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[40],{"name":41,"class":6},"Clin-Experts","100637983","observational-study-of-rhinosedal-in-acute-nasal-obstruction-100637983",false,"NCT07620522","Observational Study of RHINOSEDAL in Acute Nasal Obstruction","Prospective Multicenter Before-After Study in Children and Adults Treated for Acute Nasal Obstruction With RHINOSEDAL","Inclusion Criteria:\n\n* Age 8 years or older.\n* Acute nasal obstruction evolving for less than 48 hours associated with common cold, allergic or non-allergic rhinitis, or rhinosinusitis.\n* Baseline NOSE score \\>40\u002F100.\n* No warning signs such as pus, unilateral obstruction, bleeding, or pain.\n* RHINOSEDAL prescribed by the investigator.\n* Written informed consent signed.\n* Affiliated with a health insurance system.\n\nExclusion Criteria:\n\n* Known anatomical cause of chronic nasal congestion.\n* Corticosteroid use within the previous 2 days.\n* NSAID use within the previous 2 days.\n* Sympathomimetic use within the previous 2 days.\n* Nasal decongestant or nasal irrigation within the previous 2 days.\n* Antihistamines unless stable for more than 48 hours and maintained.\n* Contraindication listed in the RHINOSEDAL instructions for use.\n* Patient under legal protection.\n* Pregnant or breastfeeding women.","ALL","8 Years",{"count":52,"type":53},126,"ESTIMATED","OBSERVATIONAL","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.",[57,58,59,60,61],"Nasal Obstruction","Common Cold","Allergic Rhinitis","Non-allergic Rhinitis","Rhinosinusitis",[63,64,65,66,67,68,69,70,71,72],"nasal obstruction","NOSE score","rhinitis","rhinosinusitis","common cold","nasal congestion","saline irrigation","medical device","PMCF","real-world evidence","NOT_YET_RECRUITING","2026-05-27",{"date":76,"type":77},"2026-06-02","ACTUAL",{"date":79,"type":53},"2026-10-15",{"date":81,"type":53},"2027-12-31",{"name":5,"class":6},1]