Effect of Pleuran on the Clinical Course of Patients With Chronic Rhinosinusitis - EPCCOR Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 5
- 主要终点
- change in use of antibiotics
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active group: Standard of care treatment and Imunoglukan P4H® capsules
standard 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
干预措施: Imunoglukan P4H® capsules (Dietary Supplement)
Control group: Standard of care treatment
Standard of care treatment (INCS and saline irrigation) according to the EPOS guidelines indicated by the treating physician
结局指标
主要结局
change in use of antibiotics
时间窗: from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)
change in use of intranasal corticosteroids
时间窗: from enrolment (day1) through study completion (12 months) at each study visit (every 3 months)
change in the number of chronic rhinosinusitis exacerbations
时间窗: from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)
change in the incidence of respiratory tract infections
时间窗: from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months)
次要结局
- change in the severity of chronic rhinosinusitis according to Rhinoendoscopic examination(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(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(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(from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months))
- Incidence of Treatment-Emergent Adverse Events(from enrolment (day 1) through study completion (12 months) at each study visit (every 3 months))