Effect of Pleuran on the Clinical Course of Patients With Chronic Rhinosinusitis

NCT07460934 | Completed

• 1 other identifier: EPCCOR
• Study Type: interventional
• Target: 85
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Chronic Rhinosinusitis (CRS); Exacerbations; Respiratory Tract Infections (RTI); Antibiotic Prophylaxis

Keywords

pleuran; beta-glucan; immunomodulation; prevention; respiratory tract infection; chronic rhinosinusitis; exacerbations; antibiotics; snot-22; nasal swab

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• change in the severity of chronic rhinosinusitis according to Rhinoendoscopic examination

  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

  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

  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

  from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)

• Incidence of Treatment-Emergent Adverse Events

  from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)

Study Arms (2)

Active group: Standard of care treatment and Imunoglukan P4H® capsules

EXPERIMENTAL

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

Control group: Standard of care treatment

NO INTERVENTION

Standard of care treatment (INCS and saline irrigation) according to the EPOS guidelines indicated by the treating physician

Interventions

Imunoglukan P4H® capsules DIETARY_SUPPLEMENT

1 capsule contains 100 mg of IMG® and 100 mg of vitamin C

Active group: Standard of care treatment and Imunoglukan P4H® capsules

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pleuran, s.r.o.: lead

Study Sites (5)

Department of Pediatric ENT, University Hospital Brno - Children's Hospital, Černopolní 9, Brno, Czechia 613 00

Brno, Czechia, 61300, Czechia

Location

ORL department, University Hospital Brno, Jihlavská 25

Brno, Czechia, 62500, Czechia

Location

Sante s.r.o, Zdravomed 2, Cesta k nemocnici 1

Banská Bystrica, Slovensko, 97401, Slovakia

Location

ORL department, F.D. Roosevelt University Hospital with Policlinic

Banská Bystrica, Slovensko, 97517, Slovakia

Location

ORL-HP s.r.o., Nemocničná - poliklinika 1

Veľký Krtíš, Slovensko, 99001, Slovakia

Location

Related Publications (5)

• 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: 39044388 BACKGROUND

• 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: 40583784 BACKGROUND

• 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: 36291990 BACKGROUND

• 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: 33426863 BACKGROUND

• 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.

  PMID: 21890184 BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Barbora Uhliarová, MD., PhD., MPH

  ORL department, F.D. Roosevelt University Hospital with Policlinic, Banská Bystrica, Slovensko, Slovakia, 97517

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: March 10, 2026
• Study Start: November 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

SL (3); CZ (2)