Effect of Pleuran on the Clinical Course of Patients With Chronic Rhinosinusitis - EPCCOR Study
Phase: NA
Conditions: Chronic Rhinosinusitis (CRS), Exacerbations, Respiratory Tract Infections (RTI), Antibiotic Prophylaxis
Sponsor: Pleuran, s.r.o.

 
EPCCOR study, version 1, 05-10-2022 
 
1 z 2 
 
 
Effect of pleuran (β-glucan from Pleurotus ostreatus) on the clinical course of 
patients with chronic rhinosinusitis. 
EPCCOR study 
 
SUMMARY OF STUDY PROTOCOL 
Title of clinical research: 
Effect of Pleuran (β-glucan from Pleurotus Ostreatus) on the Clinical 
Course of Patients With Chronic Rhinosinusitis. 
Acronym: 
EPCCOR 
Principal investigators:  
doc. MUDr. Milan Urík, Ph.D.1, Phone:  +420 532 234 440, Email: 
urik.milan@fnbrno.cz 
MUDr. Barbora Uhliarová, PhD., MPH3  Phone: +421 48 441 2945, +421 911 
499 084, Email: b.uhliarova@gmail.com 
Investigators: 
MUDr. Vít Kruntorád1 
MUDr. Petr Vaverka2 
MUDr. Karolína Hanulová4 
MUDr. Margaréta Lásková5 
Investigating sites: 
1Department of Pediatric ENT, University Hospital Brno - Children's 
Hospital, Černopolní 9, Brno, Czechia 613 00 
2ORL department, University Hospital Brno, Jihlavská 25, Brno, Czechia 625 
00 
3ORL department, F.D. Roosevelt University Hospital with Policlinic, Banská 
Bystrica, Slovakia 
4ORL private practice – Sante s.r.o, Zdravomed 2, Cesta k nemocnici 1, 
Banská Bystrica, Slovakia 
5ORL private practice  – ORL-HP s.r.o., Nemocničná – poliklinika 1, Veľký 
Krtíš, Slovakia 
Study design: 
Multicentre, prospective, randomized, open-label, controlled study with a 
dietary supplement Imunoglukan P4H® capsules in newly diagnosed 
patients over 12 years old with chronic rhinosinusitis without nasal polyps. 
Project summary: 
Chronic rhinosinusitis (CRS) is a serious and growing health issue. The 
quality of life of patients with CRS is, in some areas, even worse than that 
of patients with chronic heart failure, chronic obstructive pulmonary 
disease, or chronic back pain. 
A well-functioning immune system is essential for alleviating CRS 
symptoms and improving disease outcomes. Currently, there is no clinical 
study evaluating the effect of pleuran (β-glucan from Pleurotus ostreatus) 
in patients with CRS.  
The primary goal of this clinical research is to learn if Imunoglukan P4H® 
as an add-on therapy to standard of care treatment according to the 
EPOS guidelines can help to prevent CRS exacerbations, respiratory tract 
infections and reduce the use of antibiotics and intranasal corticosteroids 

 
EPCCOR study, version 1, 05-10-2022 
 
2 z 2 
 
(INCS) in newly diagnosed children over 12 years old 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 (INCS 
and saline irrigation) as prescribed by their treating physician. 
Patients will be proportionally randomized into two arms: 
Group A: standard of care treatment with INCS and saline irrigation + 
Imunoglukan P4H® capsules (IMG® 100 mg + Vitamin C 100 mg) at a dose 
of 2 capsules once daily for 3 months, then there will be three months 
follow-up (without Imunoglukan P4H®). This cycle (3-month treatment 
and 3-month follow-up) will be repeated twice (only participants in the 
active group). 
Group B:  standard of care treatment with INCS and saline irrigation  
Study population: 
Newly diagnosed patients over 12 years old with a diagnosis of chronic 
rhinosinusitis without nasal polyps meeting the inclusion criteria  
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) 

 
EPCCOR study, version 1, 05-10-2022 
 
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• 
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 
Primary endpoints: 
To evaluate the effect of Imunoglukan P4H® capsules as an add-on therapy 
to the standard of care treatment according to the EPOS guidelines in 
patients with CRS without nasal polyps on reduction of: 
• 
number of CRS exacerbations, 
• 
use of antibiotics, 
• 
use of intranasal corticosteroids, 
• 
incidence of respiratory tract infections. 
Secondary endpoints: 
To evaluate the effect of Imunoglukan P4H® capsules as an add-on therapy  
to the standard of care treatment according to the EPOS guidelines in 
patients with CRS  without nasal polyps on: 
• 
severity of CRS, 
• 
subjective signs of CRS, 
• 
objective signs of CRS, 
• 
microbiological cultivation in the upper aerodigestive tract,  
• 
safety and tolerability 
Number of Patients: 
• 
Czech republic: 60 patients enrolled by investigators at 2 centres, 
randomized into active and control groups (30+30) 
• 
Slovakia:  100  patients enrolled by investigators at 3 centres, 
randomized into active and control groups (50+50) 
Study Duration: 
01.11. 2022 – 31.12. 2025