Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:25 AM
Study NCT ID:
NCT07460934
Status:
COMPLETED
Last Update Posted:
2026-03-10
First Post:
2025-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pleuran on the Clinical Course of Patients With Chronic Rhinosinusitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-05', 'size': 224334, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-06T10:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in the number of chronic rhinosinusitis exacerbations', 'timeFrame': 'from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)'}, {'measure': 'change in use of antibiotics', 'timeFrame': 'from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)'}, {'measure': 'change in use of intranasal corticosteroids', 'timeFrame': 'from enrolment (day1) through study completion (12 months) at each study visit (every 3 months)'}, {'measure': 'change in the incidence of respiratory tract infections', 'timeFrame': 'from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)'}], 'secondaryOutcomes': [{'measure': 'change in the severity of chronic rhinosinusitis according to Rhinoendoscopic examination', 'timeFrame': 'from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)', 'description': 'Rhinoendoscopic examination performed by physician (assessed parameters included: polyps, oedema, nasal mucosa secretion).\n\nEach parameter (polyps, oedema, nasal mucosa secretion) will be assessed in a 3 or 4-point scale. The examination is conducted for each nostril, with the total score being the sum of all evaluated parameters.\n\nAssessment Scale (3-point: 0, 1, 2)\n\n* Polyps assessement scale (4-point: 0, 1, 2, 3): 0 = None; 1 = In middle meatus; 2 = Beyond middle meatus; 3 = complete closure of the nasal meatus.\n* Oedema assessement scale (3-point: 0, 1, 2): 0 = Absent; 1 = Mild; 2 = Severe.\n* Nasal mucosa secretion assessement scale (3-point: 0, 1, 2): 0 = None; 1 = Clear/thin; 2 = Thick/purulent'}, {'measure': 'change in the severity of chronic rhinosinusitis according to VAS scale', 'timeFrame': 'from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)', 'description': 'VAS scale (patient-reported measure of symptom severity using a 0 to 10 scale, with 0 being no symptoms and 10 being the most severe)'}, {'measure': 'change in the severity of chronic rhinosinusitis according to Sino-Nasal Outcome Test', 'timeFrame': 'from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)', 'description': 'Sino-Nasal Outcome Test (SNOT-22 Questionnaire - covers a broad range of health-related QoL problems, including physical problems, functional limitations and emotional consequences. The questionnaire is converted into a score of 0-110, with higher scores indicating a greater impact on QoL.) - patient reported questionnaire'}, {'measure': 'change in microbiological cultivation in the upper aerodigestive tract', 'timeFrame': 'from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)', 'description': 'Examination of microbiome changes was assessed by collecting nasal and oropharyngeal swabs, followed by microbiome analysis.'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)', 'description': 'Safety was monitored by number of participants with treatment-related adverse events.\n\nTolerability was assessed by product acceptance and adherence to study treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pleuran', 'beta-glucan', 'immunomodulation', 'prevention', 'respiratory tract infection', 'chronic rhinosinusitis', 'exacerbations', 'antibiotics', 'snot-22', 'nasal swab'], 'conditions': ['Chronic Rhinosinusitis (CRS)', 'Exacerbations', 'Respiratory Tract Infections (RTI)', 'Antibiotic Prophylaxis']}, 'referencesModule': {'references': [{'pmid': '39044388', 'type': 'BACKGROUND', 'citation': 'Hong SN, Yang SK, Kim SG, Han SA, Park JA, Cha H, Kim JK, Yoon SY, Eun KM, Kim DW. Endotype and Phenotype Related Postoperative Effects of Bacterial Lysate in Chronic Rhinosinusitis. Ann Otol Rhinol Laryngol. 2024 Sep;133(9):805-813. doi: 10.1177/00034894241264459. Epub 2024 Jul 23.'}, {'pmid': '40583784', 'type': 'BACKGROUND', 'citation': 'Huang X, Zhang X, Zhang Z, Liu M, Bai D, Yang R, Yang C. Bacterial lysates in allergic rhinitis and chronic rhinosinusitis: Mechanisms and clinical evidence. Sci Prog. 2025 Apr-Jun;108(2):368504251355373. doi: 10.1177/00368504251355373. Epub 2025 Jun 30.'}, {'pmid': '36291990', 'type': 'BACKGROUND', 'citation': 'Brzost J, Czerwaty K, Dzaman K, Ludwig N, Piszczatowska K, Szczepanski MJ. Perspectives in Therapy of Chronic Rhinosinusitis. Diagnostics (Basel). 2022 Sep 23;12(10):2301. doi: 10.3390/diagnostics12102301.'}, {'pmid': '33426863', 'type': 'BACKGROUND', 'citation': "La Mantia I, Gelardi M, Drago L, Aragona SE, Cupido G, Vicini C, Berardi C, Ciprandi G; Italian Study Group on Upper Respiratory Infections: Albanese G, Anni A, Antoniacomi G, Artoni S,Asprella G, Azzaro R, Azzolin A, Balduzzi A, Barbarino I, Berardi C, Bertetto BI, Bianchi A, Bianco N,Bonanno A, Bordonaro C, Brindisi AM, Bucolo S, Bulzomi AG, Caligo G, Capaccio P, Capelli M, Capone A,Carboni S, Carluccio G, Casaula M, Cassano M, Cavaliere M, Ciabattoni A, Conti A, Cordier A, Cortellessa F,Costanzo M, Cupido F, D'Ascanio L, Danza C, D'Auria C, De Ciccio M, De Luca C, D'Emila M, Dessi R,Di Lullo A, D'Urso M, Falcetti S, Falciglia R, Fera G, Ferrari G, Ferraro SM, Fini O, Fiorella M, Floriddia A,Asprea F, Fusco C, Fuson R, Gallo A, Gambardella T, Gambardella G, Giangregorio F, Gramellini G, Ierace M, Ingria F, La Paglia A, Lanza L, Lauletta R, Lavazza P, Leone M, Lovotti P, Luperto P, Maniscalco F,Marincolo I, Martone R, Melis A, Messina A, Milone V, Mirra N, Montanaro SC, Muia F, Nacci A, Nardello E,Paderno L, Padovani D, Palma A, Paoletti M, Pedrotti I, Petrillo F, Piccolo M, Pinto P, Policarpo M, Raguso M,Ranieri A, Romano G, Rondinelli M, Russo C, Scotto Di Santillo L, Sequino G, Serraino EM, Spahiu I, Spano G,Stabile C, Stagni G, Stellin M, Tassi S, Tomacelli G, Tombolini A, Valenzise V, Zirone A. Probiotics in the add-on treatment of rhinosinusitis: a clinical experience. J Biol Regul Homeost Agents. 2020 Nov-Dec;34(6 Suppl. 1):27-34."}, {'pmid': '21890184', 'type': 'BACKGROUND', 'citation': 'Hamilos DL. Chronic rhinosinusitis: epidemiology and medical management. J Allergy Clin Immunol. 2011 Oct;128(4):693-707; quiz 708-9. doi: 10.1016/j.jaci.2011.08.004. Epub 2011 Sep 3.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical research is to learn if Imunoglukan P4H® as an add-on therapy to the standard of care treatment according to the EPOS guidelines (intranasal corticosteroids and saline irrigation) can help to prevent CRS exacerbations, respiratory tract infections and reduce the use of antibiotics and intranasal corticosteroids in newly diagnosed children over 12 years of age and adults with CRS without nasal polyps.\n\nThe investigational product, Imunoglukan P4H® capsules, will be added to the standard of care treatment according to the EPOS guidelines (intranasal corticosteroids and saline irrigation) as prescribed by their treating physician.', 'detailedDescription': 'Participants: Newly diagnosed patients over 12 years of age with a diagnosis of chronic rhinosinusitis without nasal polyps meeting the inclusion criteria.\n\nSites: 5; Czech republic (2) and Slovakia (3) Study duration: 12 moths: 3 months treatment + 3 months follow-up + 3 months treatment + 3 months follow-up\n\nRandomization:\n\n* Control group: Standard of care treatment according to EPOS guidelines (INCS and saline irrigation)\n* Active group: Standard of care treatment according to EPOS guidelines (INCS and saline irrigation) + Imunoglukan P4H® capsules (IMG® 100 mg + Vitamin C 100 mg in 1 capsule)\n\nParticipants will:\n\n* take standard of care treatment according to EPOS guidelines.\n* take Imunoglukan P4H® every day for 3 months then there will be three months follow-up (without Imunoglukan P4H®), this cycle will be repeated twice (only participants in the active group).\n* visit the clinic for control visits one month after the study initiation and then every three months during 12 months study period (SNOT-22 questionnaire, VAS scale for evaluation of CRS severity by treating physician, Swab from the upper aerodigestive tract, rhinoendoscopic examination)\n* keep a diary of their symptoms (incidence and duration of CRS exacerbations and acute respiratory infections, use of antibiotics, use of intranasal corticosteroids and other symptomatic treatments)\n* record number of emergency department visits, hospitalizations, doctor visits and missed work/school days.\n* record incidence of potential adverse events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 12 years\n* signed informed consent\n* patients with newly diagnosed CRS without nasal polyps (meeting the criteria for the definition of CRS according to EPOS)\n* patients without anatomical abnormalities causing nasal obstruction (nasal septal deformity, nasal turbinate hyperplasia, tumours, craniofacial deformities)\n* patients able and willing to complete the questionnaires, undergo rhinoendoscopic examination, upper aerodigestive tract swabs and follow-up outpatient examinations\n\nExclusion Criteria:\n\n* refused informed consent\n* inability/unwillingness to complete the questionnaire, undergo rhinoendoscopic examination, upper aerodigestive tract swabs, follow-up outpatient examinations\n* inability/unwillingness to use the product in accordance with the research protocol and compliance \\< 75%\n* patients with protracted rhinosinusitis, exacerbations rhinosinusitis with the presence of an asymptomatic period\n* patients with CRS during conservative treatment\n* patients with CRS after previous surgical treatment\n* patients with grade 3 nasal polyps\n* patients with adenoid vegetations/persistent pharyngeal tonsils (especially if children are included in the study)\n* patients with CRS with anatomical abnormalities causing nasal obstruction (septal deformity, turbinate hyperplasia, tumors, craniofacial abnormalities)\n* patients with significant immunodeficiency\n* patients with mucociliary transport disorders (e.g. cystic fibrosis, primary ciliary dyskinesia)\n* patients taking other immunomodulating preparations regularly and for a long time (e.g. beta-glucans, Preventan, vitamins C and D, probiotics, Echinacea, bacterial lysates, etc.)\n* pregnant and breastfeeding women'}, 'identificationModule': {'nctId': 'NCT07460934', 'acronym': 'EPCCOR', 'briefTitle': 'Effect of Pleuran on the Clinical Course of Patients With Chronic Rhinosinusitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pleuran, s.r.o.'}, 'officialTitle': 'Effect of Pleuran on the Clinical Course of Patients With Chronic Rhinosinusitis - EPCCOR Study', 'orgStudyIdInfo': {'id': 'EPCCOR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active group: Standard of care treatment and Imunoglukan P4H® capsules', 'description': 'standard of care treatment (INCS and saline irrigation) + Imunoglukan P4H® capsules (IMG® 100 mg + Vitamin C 100 mg in 1 capsule) at a dose of 2 capsules once daily for 3 months, then there will be 3 months follow-up (without administration of Imunoglukan P4H®).\n\nThis cycle (3-month treatment and 3-month follow-up) will be repeated twice during 12-month study period\n\nDosage:\n\n3-months treatment (2 capsules daily) + 3-months follow-up + 3-months treatment (2 capsules daily) + 3-months follow-up', 'interventionNames': ['Dietary Supplement: Imunoglukan P4H® capsules']}, {'type': 'NO_INTERVENTION', 'label': 'Control group: Standard of care treatment', 'description': 'Standard of care treatment (INCS and saline irrigation) according to the EPOS guidelines indicated by the treating physician'}], 'interventions': [{'name': 'Imunoglukan P4H® capsules', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 capsule contains 100 mg of IMG® and 100 mg of vitamin C', 'armGroupLabels': ['Active group: Standard of care treatment and Imunoglukan P4H® capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61300', 'city': 'Brno', 'state': 'Czechia', 'country': 'Czechia', 'facility': "Department of Pediatric ENT, University Hospital Brno - Children's Hospital, Černopolní 9, Brno, Czechia 613 00", 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '62500', 'city': 'Brno', 'state': 'Czechia', 'country': 'Czechia', 'facility': 'ORL department, University Hospital Brno, Jihlavská 25', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '97401', 'city': 'Banská Bystrica', 'state': 'Slovensko', 'country': 'Slovakia', 'facility': 'Sante s.r.o, Zdravomed 2, Cesta k nemocnici 1', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'zip': '97517', 'city': 'Banská Bystrica', 'state': 'Slovensko', 'country': 'Slovakia', 'facility': 'ORL department, F.D. Roosevelt University Hospital with Policlinic', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'zip': '99001', 'city': 'Veľký Krtíš', 'state': 'Slovensko', 'country': 'Slovakia', 'facility': 'ORL-HP s.r.o., Nemocničná - poliklinika 1', 'geoPoint': {'lat': 48.21059, 'lon': 19.35043}}], 'overallOfficials': [{'name': 'Barbora Uhliarová, MD., PhD., MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ORL department, F.D. Roosevelt University Hospital with Policlinic, Banská Bystrica, Slovensko, Slovakia, 97517'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pleuran, s.r.o.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}