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:
Pleuran, s.r.o.
Organization:
Study Overview
Official Title:
Effect of Pleuran on the Clinical Course of Patients With Chronic Rhinosinusitis - EPCCOR Study
Status:
COMPLETED
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPCCOR
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.
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: