[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Laboratoires Gilbert\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100613522","evaluation-of-a-hypertonic-seawater-aerosol-therapy-solution-in-adults-and-children-100613522",false,"NCT07267689","Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children","Performance and Safety Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children With Upper Respiratory Tract Infection: a Prospective and Multicenter Study","AIR","Inclusion Criteria:\n\n1. Adult subject voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures.\n2. Minor subjects (7-17 years old) given informed assent to investigation participation in writing encompassing consent to data recording and verification procedures\n3. Male and female subjects, aged from 2 years old;\n4. Subject diagnosed with URTIs such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold based on the medical examination done by the doctor.\n5. Subject willing to adhere to the requirements of the protocol, including availability for follow-up visits\n6. Subject who agrees to no use decongestants, corticosteroids, antibiotics, allergen-specific immunotherapy, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), local nasal antiseptics, other nasal saline solutions or irrigations, nasal sprays, nasal creams or gels, systemic analgesics or antipyretics (except paracetamol if needed);\n7. Subject who is able to comply with the study requirements, at the Investigator's appreciation.\n8. For minor (\\\u003C18) subjects, parents\u002Fguardians willing and able to sign written consent\n9. Subject able and willing to use an internet-enabled device (computer, tablet, or smartphone) to complete study procedures (online questionnaires) and have regular access to a device with internet connectivity (personal or household device) for the duration of the study.\n\nExclusion Criteria:\n\n1. Person with hypersensitivity to seawater\n2. Subject who previously undergone bronchospasm\n3. Children under 2 years of age\n4. Pregnant and breastfeeding women\n5. Onset of URTI symptoms \\> 48 hours\n6. Subject with COVID or flu\n7. Subject presenting alarm symptoms (periorbital oedema\u002Ferythema, displaced globe, double vision, ophthalmoplegia, reduced visual acuity, severe headache, frontal swelling, signs of sepsis, sign of meningitis, neurological signs) at the day of inclusion\n8. Subject known to have allergy to the components of the masks that is used with the inhalation device;\n9. Subject with asthma,\n10. Subject presenting infection or pathology of the inferior respiratory tracts;\n11. Subject with chronic nasal obstruction (polypes)\n12. Subject who used any decongestants, corticosteroids, antibiotics or allergen-specific immunotherapy within 4 weeks prior to inclusion;\n13. Subject who used any antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs) or local nasal antiseptics within 7 days prior to inclusion;\n14. Subject who used any nasal saline solutions or irrigations, nasal sprays, nasal creams or gels, systemic analgesics or antipyretics within 24 hours prior to inclusion;\n15. Subject with drug or alcohol abuse\n16. Subjects who is deprived for their freedom by administrative or legal decision\n17. Subject living in a social or sanitary establishment.\n18. Subject being in an exclusion period for a previous study or with a current or recent (\\\u003C3 months) participation in another investigational study involving a drug or combined device with drug.\n19. Other condition preventing the subject to participate the study in the investigator's opinion: subject deemed unreliable or incapable of understanding and complying with the study assessment or unrealistic expectations of treatment results","ALL","2 Years",{"count":20,"type":21},110,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to evaluate the tolerance, the performance and safety of this device, 22‰ Hypertonic seawater aerosol therapy solution in unidose container, to treat adult and peadiatric patients with of upper respiratory tract infection such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold.\n\nThe main questions it aims to answer are to assess if the 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation:\n\n* improve nasal symptoms relief;\n* improve sleep quality;\n* improve mucus fluidizing;\n* is safe and well tolerated.\n\nThe study is none comparative and will assess prospectively the symptomatic and functional benefits, the tolerance and the general safety of the medical device when used as an aerosol therapy solution, measured by change from baseline.\n\nTreatments will be done at home and participants will be required to perform two on sites visits and to complete questionnaires and scales for 7 consecutive days from the treatment starting.",[27,28,29,30,31],"Upper Resp Tract Infection","Rhinitis Acute","Rhinopharyngitis","Cold Symptom","Rhinitis Viral",[33,34,35,36],"hypertonic seawater","upper respiratory tract infection (URTIs)","inhalation","nebulization","RECRUITING","2026-05-18",{"date":40,"type":41},"2026-05-19","ACTUAL",{"date":43,"type":41},"2026-04-21",{"date":45,"type":21},"2026-06",{"name":47,"class":48},"Laboratoires Gilbert","INDUSTRY",6,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":5},"100560673","performance-and-safety-assessment-of-the-mechanical-decongestant-seawater-spray-enriched-with-essential-oils-from-laboratoires-gilbert-in-patient-with-acute-rhinitis-associated-with-nasal-obstruction-100560673","NCT06580210","Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction","Prospective Multicenter Clinical Investigation to Evaluate the Performance and the Safety of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert (DEMECA)","DEMECA","Inclusion Criteria:\n\n* 1\\. Patient ≥ 12 years,\n* 2\\. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhynopharyngitis (cold), rhinosinusitis, or during non-infectious episodes as allergic rhinitis,\n* 3\\. a. Informed adult patient who has given written consent prior to any study specific procedure,\n* b. Informed minor patients who has given assent and whose legal guardians have given written consent prior to any study specific procedure,\n* 4\\. Patient able to meet the study requirements (questionnaire completion),\n* 5\\. Patient affiliated to a social security scheme.\n\nExclusion Criteria:\n\n* 1\\. Patient who does not want to participate to the clinical investigation,\n* 2\\. Hypersensitivity to seawater and\u002For known allergies to any of the ingredients of the spray,\n* 3\\. A child with a history of febrile convulsions,\n* 4\\. Diseases leading to respiratory insufficiency,\n* 5\\. Patient suffering from nasal deformity or nasal polyps leading to chronic nasal obstruction,\n* 6\\. Patient on local ans systemic vasoconstrictors, local and systemic corticosteroids and antihistamines, non-steroidal anti-inflammatory (NSAIDs), antibiotics and local antiseptics,\n* 7\\. Concomitant use of other nasal sprays, essential oils for local nasal use and nsal cream or gel,\n* 8\\. Patient under guardianship, curatorship of safeguard of justice.","12 Years",{"count":60,"type":21},114,"OBSERVATIONAL","The purpose of this post-market clinical investigation is to assess the performance and the safety of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert. The study will evaluate the results of the spray on the acute rhinitis with nasal obstruction over a 7 days period.",[64,65,66,29,67],"Acute Rhinitis","Nasal Obstruction","Rhinosinusitis","Allergic Rhinitis","2025-11-18",{"date":70,"type":41},"2025-11-21",{"date":72,"type":41},"2024-10-22",{"date":74,"type":21},"2026-06-07",{"name":47,"class":48},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100477237","safety-and-performance-assessment-of-the-decongestant-seawater-spray-pocket-valve-enriched-with-essential-oils-in-patients-with-acute-rhinitis-associated-with-nasal-obstruction-devalpo-100477237","NCT05494346","Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: \"DEVALPO\"","Prospective Multicenter Clinical Investigation Evaluating the Performance and Safety of Gilbert Laboratories' Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils","DEVALPO","Inclusion Criteria:\n\n* 1\\. Patient ≥ 12 years.\n* 2\\. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhinopharyngitis (cold), rhinosinusitis, or during non-infectious episodes such as allergic rhinitis.\n* 3\\. a. Informed adult patient who has given written consent prior to any study specific procedure. b. Informed minor patient who has given assent and whose legal guardians have given written consent prior to any study-specific procedure.\n* 4\\. Patient able to meet the study requirements for monitoring, spray use, and questionnaire completion.\n* 5\\. Patient affiliated to a social security scheme.\n\nExclusion Criteria:\n\n* 1\\. Pregnant and\u002For breastfeeding woman\n* 2\\. Hypersensitivity to seawater and\u002For known allergies to any of the ingredients of the spray.\n* 3\\. Diseases causing narrowing of the airways (e.g. asthma, chronic obstructive pulmonary disease (COPD)) and\u002For respiratory insufficiency.\n* 4\\. Patients with uncontrolled asthma (GINA score greater than or equal to 4)\n* 5\\. Patients undergoing allergy desensitization\n* 6\\. Patients suffering from chronic nasal obstruction due to a deformation of the nasal wall or nasal polyps. creams or gels.\n* 7\\. Patients taking local and systemic vasoconstrictors, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotics, and local antiseptics.\n* 8\\. Concomitant use of other nasal sprays, essential oils for local nasal use, creams, or gels for the nose.\n* 9\\. Patients under guardianship, conservatorship, or legal protection.",{"count":85,"type":21},101,[24],"The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.",[64,65,66,29,67],"2025-09-19",{"date":91,"type":41},"2025-09-25",{"date":93,"type":41},"2023-06-23",{"date":95,"type":21},"2026-06-30",{"name":47,"class":48},5,""]