Effect of Pleuran on the Clinical Course of Patients With Chronic Rhinosinusitis (EPCCOR)

Effect of Pleuran on the Clinical Course of Patients With Chronic Rhinosinusitis - EPCCOR Study

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.

The 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.

Study Overview

• Status: Completed
• Conditions: Antibiotic Prophylaxis; Exacerbations; Respiratory Tract Infections (RTI); Chronic Rhinosinusitis (CRS)
• Intervention / Treatment: Dietary supplement: Imunoglukan P4H® capsules

Detailed Description

Participants: Newly diagnosed patients over 12 years of age with a diagnosis of chronic rhinosinusitis without nasal polyps meeting the inclusion criteria.

Sites: 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

Randomization:

• Control group: Standard of care treatment according to EPOS guidelines (INCS and saline irrigation)
• 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)

Participants will:

• take standard of care treatment according to EPOS guidelines.
• 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).
• 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)
• 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)
• record number of emergency department visits, hospitalizations, doctor visits and missed work/school days.
• record incidence of potential adverse events

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Czechia
    • Brno, Czechia, Czechia, 61300
      • Department of Pediatric ENT, University Hospital Brno - Children's Hospital, Černopolní 9, Brno, Czechia 613 00
    • Brno, Czechia, Czechia, 62500
      • ORL department, University Hospital Brno, Jihlavská 25
• Slovakia
  • Slovensko
    • Banská Bystrica, Slovensko, Slovakia, 97401
      • Sante s.r.o, Zdravomed 2, Cesta k nemocnici 1
    • Banská Bystrica, Slovensko, Slovakia, 97517
      • ORL department, F.D. Roosevelt University Hospital with Policlinic
    • Veľký Krtíš, Slovensko, Slovakia, 99001
      • ORL-HP s.r.o., Nemocničná - poliklinika 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age over 12 years
• signed informed consent
• patients with newly diagnosed CRS without nasal polyps (meeting the criteria for the definition of CRS according to EPOS)
• patients without anatomical abnormalities causing nasal obstruction (nasal septal deformity, nasal turbinate hyperplasia, tumours, craniofacial deformities)
• patients able and willing to complete the questionnaires, undergo rhinoendoscopic examination, upper aerodigestive tract swabs and follow-up outpatient examinations

Exclusion Criteria:

• refused informed consent
• inability/unwillingness to complete the questionnaire, undergo rhinoendoscopic examination, upper aerodigestive tract swabs, follow-up outpatient examinations
• inability/unwillingness to use the product in accordance with the research protocol and compliance < 75%
• patients with protracted rhinosinusitis, exacerbations rhinosinusitis with the presence of an asymptomatic period
• patients with CRS during conservative treatment
• patients with CRS after previous surgical treatment
• patients with grade 3 nasal polyps
• patients with adenoid vegetations/persistent pharyngeal tonsils (especially if children are included in the study)
• patients with CRS with anatomical abnormalities causing nasal obstruction (septal deformity, turbinate hyperplasia, tumors, craniofacial abnormalities)
• patients with significant immunodeficiency
• patients with mucociliary transport disorders (e.g. cystic fibrosis, primary ciliary dyskinesia)
• 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.)
• pregnant and breastfeeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active group: Standard of care treatment and Imunoglukan P4H® capsules; 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®). This cycle (3-month treatment and 3-month follow-up) will be repeated twice during 12-month study period Dosage: 3-months treatment (2 capsules daily) + 3-months follow-up + 3-months treatment (2 capsules daily) + 3-months follow-up	Dietary supplement: Imunoglukan P4H® capsules; 1 capsule contains 100 mg of IMG® and 100 mg of vitamin C
No Intervention: Control group: Standard of care treatment; Standard of care treatment (INCS and saline irrigation) according to the EPOS guidelines indicated by the treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in the number of chronic rhinosinusitis exacerbations	from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)
change in use of antibiotics	from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)
change in use of intranasal corticosteroids	from enrolment (day1) through study completion (12 months) at each study visit (every 3 months)
change in the incidence of respiratory tract infections	from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the severity of chronic rhinosinusitis according to Rhinoendoscopic examination	Rhinoendoscopic examination performed by physician (assessed parameters included: polyps, oedema, nasal mucosa secretion). Each 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. Assessment Scale (3-point: 0, 1, 2); 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.; Oedema assessement scale (3-point: 0, 1, 2): 0 = Absent; 1 = Mild; 2 = Severe.; Nasal mucosa secretion assessement scale (3-point: 0, 1, 2): 0 = None; 1 = Clear/thin; 2 = Thick/purulent	from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)
change in the severity of chronic rhinosinusitis according to VAS scale	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)	from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)
change in the severity of chronic rhinosinusitis according to Sino-Nasal Outcome Test	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	from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)
change in microbiological cultivation in the upper aerodigestive tract	Examination of microbiome changes was assessed by collecting nasal and oropharyngeal swabs, followed by microbiome analysis.	from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)
Incidence of Treatment-Emergent Adverse Events	Safety was monitored by number of participants with treatment-related adverse events. Tolerability was assessed by product acceptance and adherence to study treatment.	from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)

Collaborators and Investigators

• Sponsor: Pleuran, s.r.o.
• Investigators: Principal Investigator: Barbora Uhliarová, MD., PhD., MPH, ORL department, F.D. Roosevelt University Hospital with Policlinic, Banská Bystrica, Slovensko, Slovakia, 97517

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: August 6, 2025
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: exacerbations; prevention; immunomodulation; chronic rhinosinusitis; antibiotics; beta-glucan; respiratory tract infection; nasal swab; pleuran; snot-22
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: EPCCOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No