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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
85
1 capsule contains 100 mg of IMG® and 100 mg of vitamin C
Department of Pediatric ENT, University Hospital Brno - Children's Hospital, Černopolní 9, Brno, Czechia 613 00
Brno, Czechia, Czechia
ORL department, University Hospital Brno, Jihlavská 25
Brno, Czechia, Czechia
Sante s.r.o, Zdravomed 2, Cesta k nemocnici 1
Banská Bystrica, Slovensko, Slovakia
ORL department, F.D. Roosevelt University Hospital with Policlinic
Banská Bystrica, Slovensko, Slovakia
ORL-HP s.r.o., Nemocničná - poliklinika 1
Veľký Krtíš, Slovensko, Slovakia
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)
change in use of antibiotics
Time frame: from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)
change in use of intranasal corticosteroids
Time frame: from enrolment (day1) through study completion (12 months) at each study visit (every 3 months)
change in the incidence of respiratory tract infections
Time frame: 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 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
Time frame: 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
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)
Time frame: 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
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
Time frame: 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
Examination of microbiome changes was assessed by collecting nasal and oropharyngeal swabs, followed by microbiome analysis.
Time frame: from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)
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.
Time frame: from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)
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