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

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

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