[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654396":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":36,"studyPopulation":29,"armGroups":37,"interventions":50,"overallOfficials":29,"centralContacts":63,"locations":69,"responsibleParty":87,"collaborators":91,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":29,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":29,"enrollmentInfo":103,"targetDuration":29,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":29,"overallStatus":112,"whyStopped":29,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Liaquat University of Medical & Health Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Quality of Life Assessed by the Sino-Nasal Outcome Test-22 (SNOT-22)","Change in the impact of chronic rhinosinusitis symptoms on patients' quality of life will be assessed using the validated Sino-Nasal Outcome Test-22 (SNOT-22) scale in both study groups.","Baseline to Week 12",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Change in Nasal Congestion Severity Assessed by the Congestion Quantifier 7-Item Test (CQ7)","Change in nasal congestion severity will be assessed using the Congestion Quantifier 7-item test (CQ7) in both study groups.",{"measure":18,"description":19,"timeFrame":12},"Change in Rhinorrhea Intensity Assessed by Visual Analog Scale (VAS)","Change in rhinorrhea intensity will be assessed using a Visual Analog Scale (VAS) from 0 to 10, where 0 indicates no symptoms and 10 indicates the worst possible symptom.",{"measure":21,"description":22,"timeFrame":12},"Antibiotic Use During the Study","Antibiotic use will be assessed by recording the number of doses used and the total number of days of antibiotic use during the study period.",{"measure":24,"description":25,"timeFrame":12},"Incidence of Adverse Events During Treatment","The incidence of adverse events due to treatment will be assessed through recording of adverse events in the data collection form throughout the study period.",{"measure":27,"description":28,"timeFrame":12},"Severity of Adverse Events Assessed by CTCAE","The intensity of adverse events due to treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE).",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":29},"NONE","Bactorinol® nasal spray is a medical device based on winterized Pistacia lentiscus oil, indicated as a support in cases of nasal congestion, to promote the fluidification of secretions and soothe irritated nasal mucosa. Pistacia lentiscus derivatives have been described as having potential antimicrobial, antioxidant, and anti-inflammatory properties.\n\nThe study will evaluate whether the use of Bactorinol® nasal spray, included in a topical therapeutic strategy with intranasal corticosteroid, can improve quality of life and symptoms in patients with chronic rhinosinusitis. The study population includes patients diagnosed with chronic rhinosinusitis with nasal polyposis and without nasal polyposis.\n\nThis is a prospective, single-center, randomized, controlled study with a 1:1 allocation ratio. Participants will undergo a continuous 12-week treatment period. The treated group will receive mometasone furoate nasal spray 1 puff daily plus Bactorinol® nasal spray 3 puffs per nostril twice daily. The control group will receive mometasone furoate nasal spray 2 puffs daily.\n\nParticipants will be monitored throughout the study for safety, adherence, and clinical outcomes. Clinical evaluations and monitoring of adverse events will be performed at the beginning of the study and after 12 weeks of treatment.",[38,45],{"label":39,"type":40,"description":41,"interventionNames":42},"Treated Group","EXPERIMENTAL","Mometasone furoate nasal spray 1 puff daily plus Bactorinol® nasal spray 3 puffs per nostril 2 times daily for 12 weeks.",[43,44],"Device: Bactorinol® (manufacturer: PharmExtracta S.p.A.)","Drug: Mometasone Furoate Nasal Spray",{"label":46,"type":47,"description":48,"interventionNames":49},"Control Group","ACTIVE_COMPARATOR","Mometasone furoate nasal spray 2 puffs daily for 12 weeks.",[44],[51,58],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"DEVICE","Bactorinol® (manufacturer: PharmExtracta S.p.A.)","Bactorinol® nasal spray, 3 puffs per nostril twice daily for 12 weeks.",[39],[57],"Bactorinol® Nasal Spray",{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":29},"DRUG","Mometasone Furoate Nasal Spray","Mometasone furoate nasal spray administered for 12 weeks. The Treated Group receives 1 puff daily and the Control Group receives 2 puffs daily.",[46,39],[64],{"name":65,"role":66,"phone":67,"phoneExt":29,"email":68},"Prof. Davide Sisti, PhD","CONTACT","+39 0722 304637","davide.sisti@uniurb.it",[70],{"facility":71,"status":29,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Armonia Centro Polispecialistico","Porto Mantovano","Lombardy","46047","Italy","IT",{"type":78,"coordinates":79},"Point",[80,81],10.78995,45.18942,{"lat":81,"lon":80},[84],{"name":85,"role":66,"phone":29,"phoneExt":29,"email":86},"Giuseppe Puma, MD","giuseppe.puma@asuitn.it",{"type":88,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Dr. Amjad Khan","Professor of Clinical Biochemistry and Experimental Medicine",[92],{"name":93,"class":6},"University of Urbino \"Carlo Bo\"","100654396","bactorinol-nasal-spray-with-reduced-dose-mometasone-in-adults-with-chronic-rhinosinusitis-100654396",false,"NCT07800273","Bactorinol® Nasal Spray With Reduced-Dose Mometasone in Adults With Chronic Rhinosinusitis","Effect of a Corticosteroid-Sparing Regimen Including Pistacia Lentiscus Oil Nasal Spray on Quality of Life in Patients With Chronic Rhinosinusitis: A Randomized Controlled Study","Inclusion Criteria:\n\n* Age ≥18 years\n* Patients diagnosed with chronic rhinosinusitis with nasal polyposis (CRSwNP) and without polyposis (CRSsNP)\n* Clinical indication for treatment with intranasal corticosteroid (mometasone furoate)\n* Ability to understand and sign informed consent\n* Willingness to comply with the study protocol and follow-up visits (T0, T12 weeks)\n\nExclusion Criteria:\n\n* Neoplastic pathologies of all degrees\n* Neurological or psychiatric disorders such as to impair adherence to treatment and\u002For understanding of informed consent forms\n* Pregnancy and lactation\n* Chronic drug and\u002For alcohol use\n* Immunosuppressed subjects (primary immunodepression, oncological pathology undergoing active chemo\u002Fimmunotherapy treatment, autoimmune pathology undergoing immunosuppressive treatment)\n* Allergy, even suspected, to one or more of the excipients of the preparation under study","ALL","18 Years",{"count":104,"type":105},78,"ESTIMATED","INTERVENTIONAL",[108],"NA","Chronic rhinosinusitis (CRS) is a persistent inflammatory disease of the nose and sinuses, defined by the presence of symptoms for at least 12 weeks. Medical treatment of CRS is mainly based on topical therapies aimed at controlling mucosal inflammation and improving naso-sinus clearance. However, despite these treatments, some patients continue to experience persistent or recurrent symptoms.\n\nThis prospective, single-center, randomized, controlled, non-profit study aims to evaluate the clinical efficacy of Bactorinol® nasal spray in patients with chronic rhinosinusitis, in order to reduce the impact of CRS symptoms on patients' quality of life in a non-inferior manner compared with treatment with the full dose of mometasone furoate nasal spray.\n\nParticipants will be randomly assigned in a 1:1 ratio to receive mometasone furoate nasal spray 1 puff daily plus Bactorinol® nasal spray 3 puffs per nostril twice daily, or mometasone furoate nasal spray 2 puffs daily. The treatment period will last 12 weeks.",[111],"Chronic Rhinosinusitis","NOT_YET_RECRUITING","2026-08-28",{"date":115,"type":116},"2026-09-02","ACTUAL",{"date":118,"type":105},"2026-09-14",{"date":120,"type":105},"2027-05-31",{"name":5,"class":6},1]