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Chronic Rhinosinusitis (CRS)EPCCORNCT07460934

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

A study testing Imunoglukan P4H® capsules in people with Chronic Rhinosinusitis (CRS) and Exacerbations, run by Pleuran, s.r.o. at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
Imunoglukan P4H® capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
5 sitesin 2 countries
Study dates
1 Nov 2022to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Slovakia3 sites

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

    Banská Bystrica, Slovensko, 97401

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

    Banská Bystrica, Slovensko, 97517

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

    Veľký Krtíš, Slovensko, 99001

Other trials in Slovakia

Czechia2 sites

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

    Brno, Czechia, 61300

  • ORL department, University Hospital Brno, Jihlavská 25

    Brno, Czechia, 62500

Other trials in Czechia

About this study

Official title: 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.

Read the 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
Being tested
Imunoglukan P4H® capsules
Keywords
pleuran, beta-glucan, immunomodulation, prevention, respiratory tract infection, chronic rhinosinusitis, exacerbations, antibiotics, snot-22, nasal swab
Medical subject headings
Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imunoglukan P4H® capsulesDietary supplement

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

Study groups in NCT07460934
Study groupRoleWhat they receive
Active group: Standard of care treatment and Imunoglukan P4H® capsulesExperimentalstandard 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
Receives: Dietary Supplement: Imunoglukan P4H® capsules
Control group: Standard of care treatmentNo interventionStandard of care treatment (INCS and saline irrigation) according to the EPOS guidelines indicated by the treating physician

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in the number of chronic rhinosinusitis exacerbations

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

  2. change in use of antibiotics

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

  3. change in use of intranasal corticosteroids

    Measured: from enrolment (day1) through study completion (12 months) at each study visit (every 3 months)

  4. change in the incidence of respiratory tract infections

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

Secondary outcomes (5)

  1. 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

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

  2. 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)

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

  3. 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

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

  4. 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.

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2026
  2. Study start1 Nov 2022
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07460934
Sponsor's protocol ID
EPCCOR
Acronym
EPCCOR
Status last verified
Jan 2026
First submitted
6 Aug 2025
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

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.

    PubMed 39044388

  • 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.

    PubMed 40583784

  • 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.

    PubMed 36291990

  • 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.

    PubMed 33426863

  • 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.

    PubMed 21890184

Questions about this trial

What is this clinical trial studying?

A study testing Imunoglukan P4H® capsules in people with Chronic Rhinosinusitis (CRS) and Exacerbations, run by Pleuran, s.r.o. at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Slovakia, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in the number of chronic rhinosinusitis exacerbations (time frame: from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07460934, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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