[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rhinosinusitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rhinosinusitis":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,47,87,116,136,161,194,218],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100622428","rhinavevaluation-of-treatments-for-acute-viral-rhinitis-rhinosinusitis-and-rhinopharyngitis-100622428",false,"NCT07383493","RhinAV_Evaluation of Treatments for Acute Viral Rhinitis, Rhinosinusitis, and Rhinopharyngitis","Evaluation of Treatments for Acute Viral Rhinitis, Rhinosinusitis, and Rhinopharyngitis","RhinAV","Inclusion Criteria:\n\n* Acute viral rhinitis or acute rhinosinusitis or viral rhinopharyngitis (sneezing, rhinorrhea, nasal obstruction, cough secondary to posterior rhinorrhea, sore throat) that began less than 72 hours prior to the inclusion visit, in the investigator's judgment,\n* Effective contraception for female patients of childbearing age.\n* Cooperation and sufficient understanding to comply with the requirements of the trial.\n* Acceptance of registration in the SI-RIPH VRB file.\n* Having received informed information and agreeing to give written consent.\n* Affiliated with the French Social Security system.\n\nExclusion Criteria:\n\n* Hypersensitivity\u002Fhistory of allergy to any of the product's components,\n* Complicated rhinitis, rhinosinusitis, or rhinopharyngitis (acute bacterial sinusitis, acute otitis media, acute bronchitis, or pneumonia) or severe cough that is poorly tolerated,\n* Chronic rhinosinusitis,\n* Allergic rhinosinusitis,\n* Other ongoing treatments for acute rhinitis (local treatment, antitussives, antibiotics, antiretrovirals, corticosteroids, etc.),\n* Positive antigen test for influenza A\u002FB or COVID-19 and infection requiring etiological treatment according to the recommendations,\n* Bacterial rhinopharyngitis with positive TROD test\n* Comorbidities or health conditions deemed incompatible with the trial by the investigator,\n* Recent ENT surgery (\\\u003C6 months),\n* ENT pathology such as nasal septum deviation or other causes of nasal obstruction,\n* Pulmonary pathology (COPD, asthma, etc.),\n* Immunosuppression (as reported by the patient),\n* Pregnant or breastfeeding women,\n* Currently participating in another clinical trial, or in the exclusion period, or having received total compensation of more than €6,000 in the 12 months prior to the start of the trial,\n* Benefiting from legal protection measures (guardianship, trusteeship, deprivation of liberty, judicial protection).","ALL","18 Years","70 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"NA","The objective of this study is to conduct post-marketing clinical follow-up of four products: NS, NHE, NHG, and PIR. This follow-up will consist of collecting clinical data in real-life conditions to confirm the tolerance, safety, and efficacy of medical devices used in the treatment of acute viral rhinitis, rhinosinusitis, and rhinopharyngitis, while also assessing the benefit\u002Frisk ratio of the products.",[28,29,30,31,32,33],"Rhinitis Acute","Rhinitis Viral","Rhinosinusitis Acute","Rhinopharyngitis","Rhinitis","Rhinosinusitis","RECRUITING","2026-06-12",{"date":37,"type":38},"2026-06-15","ACTUAL",{"date":40,"type":38},"2026-02-25",{"date":42,"type":22},"2027-03",{"name":44,"class":45},"University Hospital, Clermont-Ferrand","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":46},"100637983","observational-study-of-rhinosedal-in-acute-nasal-obstruction-100637983","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","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.","8 Years",{"count":57,"type":22},126,"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.",[61,62,63,64,33],"Nasal Obstruction","Common Cold","Allergic Rhinitis","Non-allergic Rhinitis",[66,67,68,69,70,71,72,73,74,75],"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":79,"type":38},"2026-06-02",{"date":81,"type":22},"2026-10-15",{"date":83,"type":22},"2027-12-31",{"name":85,"class":86},"Laboratoires Elerte","INDUSTRY",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":46},"100604576","efficacy-of-bee-venom-phonophoresis-in-treating-chronic-sinusitis-100604576","NCT07151313","Efficacy of Bee Venom Phonophoresis in Treating Chronic Sinusitis:","Efficacy of Bee Venom Phonophoresis in Treating Chronic Sinusitis: A Double-Blind Randomized Controlled Trial","BEE-SONIC","Inclusion Criteria:\n\n* Adults aged 18 to 65 years.\n* Clinical diagnosis of chronic sinusitis (symptoms ≥ 12 weeks) or acute sinusitis confirmed by an otolaryngologist.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to bee venom or bee products.\n* Skin conditions (e.g., eczema, dermatitis, open wounds) over the area of ultrasound application.\n* Severe comorbid medical conditions (e.g., uncontrolled asthma, autoimmune disease, malignancy).\n* Pregnancy or breastfeeding.\n* Use of systemic corticosteroids, antibiotics, or other medications that may significantly alter sinusitis symptoms within 4 weeks prior to enrollment.\n* Participation in another clinical trial within the past 30 days.","65 Years",{"count":97,"type":22},30,[25],"This double-blind, randomized controlled trial (BEE-SONIC) aims to evaluate the efficacy of bee venom phonophoresis in the treatment of chronic sinusitis. Thirty adult patients (aged 18-65 years) with clinically diagnosed chronic or acute sinusitis will be randomized into two groups: the intervention group will receive bee venom phonophoresis using low-to-moderate intensity ultrasound, while the control group will receive standard care consisting of oral decongestants and saline nasal irrigation. Primary outcomes include improvement in symptom severity (SNOT-22, Visual Analog Scale) and quality of life (SF-33). Secondary outcomes include reduction in facial pain, nasal congestion, and patient satisfaction. Data will be collected at baseline, midpoint, and post-intervention, and analyzed using paired t-tests and ANOVA. The study has received ethics approval from Sinai University's Human Research Ethics Committee, and informed consent will be obtained from all participants.",[101,102,33],"Chronic Sinusitis","Acute Sinusitis",[104,105,106],"Sinusitis","Rhinosinusitis, Chronic","Rhinosinusitis, Acute","2026-05-05",{"date":109,"type":38},"2026-05-11",{"date":111,"type":22},"2026-05-15",{"date":113,"type":22},"2026-12-25",{"name":115,"class":45},"Sinai University",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":46},"100212108","nasal-potential-difference-npd-protocol-in-chronic-rhinosinusitis-100212108","NCT02038166","Nasal Potential Difference (NPD) Protocol in Chronic Rhinosinusitis","Chloride Secretagogues for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (NPD Protocol)","The patient eligibility criteria are designed to limit enrollment to healthy individuals and patients who clearly have CRS based on Sinus and Allergy health partnership criteria, but who are sufficiently well (both in terms of CRS and in terms of concomitant illness, such as asthma) to safely participate in study procedures and provide interpretable results.\n\nInclusion Criteria:\n\na. Patients with CRS will be diagnosed according to Sinus and Allergy Health Partnership symptom-based and objective criteria as follows: i. Duration of disease is qualified by continuous symptoms (≥ 2 major factors or at least 1 major factor \\& 2 minor symptoms; Table 2) for ≥ 12 consecutive weeks or ≥ 12 weeks of physical findings. ii. One of these signs of inflammation must be present and identified in association with ongoing symptoms.\n\n1. Discolored nasal drainage arising from the nasal passages, nasal polyps, or polypoid swelling as identified on physical examination with nasal endoscopy.\n2. Edema or erythema of the middle meatus or ethmoid bulla\n3. Generalized or localized erythema or edema. If it does not involve the middle meatus or ethmoid bulla, CT scan is performed to confirm a diagnosis.\n4. The CT scan must demonstrate isolated or diffuse mucosal thickening, bone changes, air-fluid levels. b. Age ≥ 19 years and Weight ≥ 50 kg c. Ability to perform NPD testing d. Negative pregnancy test (for females of childbearing potential) e. Written informed consent\n\nExclusion Criteria:\n\n1. Acute illness within 2 weeks before start of study treatment.\n2. History of major asthma attack within 2 months prior to start of study treatment.\n3. Change in intranasal medications (including use of corticosteroids, cromolyn, atrovent, phenylephrine, or oxymetazoline) within 14 days prior to start of study treatment.\n4. Positive hepatitis B surface antigen, hepatitis C antibody test, or human immunodeficiency virus (HIV) test.\n5. Hemoglobin \\\u003C10 gm\u002FdL and Serum albumin \\\u003C2.5 g\u002FdL.\n6. Abnormal liver function (serum ALT, AST, alkaline phosphatase, or total bilirubin \\>2 times upper limit of normal).\n7. Abnormal renal function (serum creatinine \\>1.5 times upper limit of normal).\n8. Pregnancy or breast feeding.\n9. History of solid organ or hematological transplantation\n10. History of autoimmune or granulomatous disorder.",{"count":124,"type":22},20,"The purpose of this study is to determine if acquired (partial) Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) deficiency contributes substantially to the pathogenic mechanisms underlying Chronic Rhinosinusitis (CRS), creating a localized environment that impairs mucociliary clearance (MCC).",[33],"2026-03-13",{"date":129,"type":38},"2026-03-17",{"date":131,"type":38},"2015-01",{"date":133,"type":22},"2027-12",{"name":135,"class":45},"University of Alabama at Birmingham",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":158,"locationsCount":160},"100585356","phase-3-the-efficacy-and-safety-of-raphamin-in-the-treatment-of-acute-rhinosinusitis-in-adult-patients-100585356","NCT06901297","The Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients","Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients","Inclusion Criteria:\n\n1. Male and female aged 18 - 75 years.\n2. Diagnosis of acute rhinosinusitis:\n\n   * 8-12 points on MSS scale;\n   * no more than 3 severe symptoms (3 points on the MSS scale)\n   * facial pain\u002Fheaviness in the facial area 1-2 points on the MSS scale.\n3. Disease duration up to 48 hours (from the onset of the first symptoms of the disease).\n4. Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by the patient.\n5. Patients who agreed to use a reliable method of contraception during the study (for men and women of reproductive potential).\n\nExclusion Criteria:\n\n1. Symptoms of acute bacterial rhinosinusitis (three or more of those below):\n\n   * fever of ≥ 38.0°C;\n   * the second wave of ARS symptoms;\n   * one-sided process;\n   * facial pain\u002Fpressure of 3 points (on the MSS scale).\n2. Recurrent ARS (≥4 episodes of ARS per year with complete resolution of symptoms between episodes).\n3. Odontogenic rhinosinusitis.\n4. Allergic (seasonal or year-round) rhinitis.\n5. Nasal polyps or clinically significant nasal septum deviation.\n6. Concomitant otitis.\n7. Use of intranasal or systemic corticosteroids for 30 days prior to the screening visit.\n8. Use of intranasal or systemic antibiotics for 30 days prior to the screening visit.\n9. Surgery for the nasal cavity and paranasal sinuses during the last 6 months before the screening visit.\n10. Any other surgery during the last 3 months.\n11. Clinical symptoms of severe influenza\u002FARVI requiring hospitalization.\n12. Suspected bacterial infection of any localization requiring the administration of antibiotics from the first day of disease.\n13. History\u002Fsuspicion of oncology of any localization (except for benign neoplasms).\n14. Exacerbation or decompensation of chronic diseases (diabetes mellitus, bronchial asthma, chronic bronchitis, chronic obstructive pulmonary disease, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of the respiratory and ENT organs, etc.) affecting the patient's ability to participate in the clinical trial.\n15. Previously diagnosed immunodeficiency of any etiology.\n16. Unstable angina or myocardial infarction during the last 6 months.\n17. Class III and IV chronic heart failure (according to the classification of the New York Heart Association, 1964).\n18. History of chronic kidney disease (classes C3-5 A3).\n19. History of liver failure (class C according to Child-Pugh).\n20. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.\n21. Pregnancy, breast-feeding, and childbirth less than 3 months before inclusion in the trial.\n22. Hypersensitivity to any component of the medicines used in the treatment.\n23. Patients who used medications listed under \"Prohibited Concomitant Treatment\" within 1 month prior to inclusion in the trial or need medications prohibited for use in the trial.\n24. Patients who, from the investigator's point of view, will not comply with the observation requirements during the trial or follow the procedure for taking the test drugs.\n25. History of mental illness, alcoholism, drug abuse, which, from the investigator's point of view, will prevent the patient from following the trial procedures.\n26. Participation in other clinical trials within 3 months prior to inclusion in this trial.\n27. Patient is related to on-site research personnel directly involved in the trial, or is the immediate family member of the investigator. 'Immediate family members' mean spouses, parents, children, or siblings, whether related or adopted.\n28. Patient is employed by OOO \"NPF \"MATERIA MEDICA HOLDING\", i.e., is an employee of the company, a temporary contract employee, or a designated official responsible for conducting the trial or their immediate family member.","75 Years",{"count":145,"type":22},552,[147],"PHASE3","Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial of the efficacy and safety of Raphamin in the treatment of acute rhinosinusitis in adult patients.",[33,30],[33,151],"Acute","2026-03-12",{"date":154,"type":38},"2026-03-16",{"date":156,"type":38},"2025-04-03",{"date":83,"type":22},{"name":159,"class":86},"Materia Medica Holding",44,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":193},"100612718","post-market-clinical-follow-up-study-of-an-isotonic-saline-solution-to-manage-nasal-congestion-in-case-of-flu-symptoms-colds-allergic-rhinitis-and-rhinosinusitis-in-infants-and-toddlers-100612718","NCT07257224","Post-market Clinical Follow-up Study of an Isotonic Saline Solution to Manage Nasal Congestion in Case of Flu Symptoms, Colds, Allergic Rhinitis and Rhinosinusitis in Infants and Toddlers","Nasal Baby","Inclusion Criteria:\n\n* Male and female infants \u002F toddlers aged 3 to 48 months (inclusive) at the time of enrolment.\n* Subjects with flu, cold, allergic rhinitis or rhinosinusitis as reported by their legal guardian(s) and\u002For medical history.\n* Subjects presenting at least moderately bothersome nasal congestion (blocked or stuffy nose) as reported by their legal guardian(s) and\u002For medical history and confirmed by the site investigator through non-diagnostic inspection.\n* Subjects suitable for nasal hygiene treatment with the study device according to its IFU.\n* Subjects with nasal congestion symptoms that began within 48 hours prior to enrolment.\n* Subjects whose legal guardian(s) signed written informed consent on their behalf to participate in the study.\n* Subject whose legal guardian(s) are willing and able to follow the IFU and comply with all study procedures.\n\nExclusion Criteria (if any severe symptoms are seen in the subject, the guardian will be advised to seek medical evaluation by the subject's physician):\n\n* Subjects with known hypersensitivity or intolerance to seawater or any of its natural mineral components (e.g., sodium, chloride, magnesium) as reported by their legal guardian(s) and\u002For medical history.\n* Subjects showing severe symptoms such as persistent fever (\\>38°C), severe cough, ear pain, or respiratory distress, as reported by their legal guardian(s) and\u002For medical history.\n* Subjects whose legal guardian(s) and\u002For medical history report any ongoing medical diagnosis or treatment for acute infection or chronic respiratory disease (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, etc.).\n* Subjects whose legal guardians(s) and\u002For medical history report any type of immunodeficiency.\n* Subjects whose legal guardian(s) and\u002For medical history report a neurological condition that may affect respiratory functioning.\n* Subjects with visible nasal injury, wounds or bleeding, or any condition that may contraindicate the use of the study device according to the device IFU.\n* Subjects who are currently participating or have participated in another clinical investigation within the last 30 days prior to enrolment.\n* Subjects using saline nasal drops or nasal sprays or pumps other than the study product within 12 hours prior to the time of enrolment or during the study.\n* Subjects using the study product within 24 hours prior to the time of enrolment in the study.\n* Subject using antibiotics, antivirals, intranasal medications, decongestants, antihistamines, mucolytics, echinacea, combination cold formulas, supplements containing ≥ 10 mg zinc that could influence symptom scores within 12 hours prior to the time of enrolment or during the study.","3 Months","48 Months",{"count":171,"type":22},83,"The goal of this observational post-market clinical follow-up study is to evaluate the safety and performance of the CE-marked nasal spray in the management of nasal congestion in case of flu, colds, allergic rhinitis and rhinosinusitis in infants and toddlers aged 3 to 48 months at day 5 post-enrolment. Enrolment does not require establishing a medical diagnosis; eligibility is based on guardian-reported nasal congestion consistent with lay use of the device.\n\nParticipants will be:\n\n* Evaluated by a healthcare professional for eligibility.\n* Receive treatment with the CE-marked nasal spray according to its Instructions for Use, for up to 14 days.\n* Have their legal guardians report symptom severity and improvement using standardized scales (Visual Analog Scale) during follow-up visits on Day 2, Day 5, and Day 14 and device usability on Day 14.\n\nThis study does not include a comparison group and reflects real-world use of the device in routine pediatric care.",[174,62,63,33,175],"Nasal Congestion","Flu Symptom",[177,178,179,180,181,182,183],"infants","toddlers","Upper Respiratory Tract Infections","Pediatric nasal spray","nasal spray","Seawater isotonic solution","Post-market clinical follow-up (PMCF)","2025-11-20",{"date":186,"type":38},"2025-12-02",{"date":188,"type":22},"2025-12",{"date":190,"type":22},"2026-11",{"name":192,"class":86},"Laboratoires Quinton International S.L.",2,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":17,"minAge":202,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":217},"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":204,"type":22},114,"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.",[207,61,33,31,63],"Acute Rhinitis","2025-11-18",{"date":210,"type":38},"2025-11-21",{"date":212,"type":38},"2024-10-22",{"date":214,"type":22},"2026-06-07",{"name":216,"class":86},"Laboratoires Gilbert",3,{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":17,"minAge":202,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},"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":227,"type":22},101,[25],"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.",[207,61,33,31,63],"2025-09-19",{"date":233,"type":38},"2025-09-25",{"date":235,"type":38},"2023-06-23",{"date":237,"type":22},"2026-06-30",{"name":216,"class":86},5]