EUCTR2017-002081-40-DE进行中（未招募）1 期
Investigation of the efficacy and safety of ANGOCIN® Anti-Infekt N versus placebo in adult patients with acute, uncomplicated rhinosinusits. A multi-center, randomized, double-blind, placebo-controlled, parallel-group phase IV clinical trial. - ANGOCOLD
Repha GmbH0 个研究点目标入组 380 人开始时间: 2017年7月13日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 380
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. signed informed consent
- •2. male and female outpatients aged =18 und =75 Jahre
- •3. diagnosis of acute (or recurrend acute) rhinosinusitis:
- •- characterized by the main symptoms with an MRSSinv score between 8 and 12 Points
- •- evidence of nasal congestion and facial pain / facial pressure is mandatory
- •- single score for facial pain / facial pressure = 1 (slight) und = 2 (moderate)
- •- symptoms occured = 3 days before study enrolment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Medical history
- •a) Diseases
- •1. Chronic rhinosinusitis (i.e. all forms and causes of persistent chronic rhinosinusitis;)
- •2. known nasal polyps (Polyposis nasi)
- •3. Cystic fibrosis
- •4. Anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation / air flow
- •5. Acute symptoms of a known allergic Rhinitis (Hayfever)
- •6. Clinically relevant findings in laboratory values (i. e. more than three times deviating from the upper or lower norm of the laboratory or significant in as assessed by the investigator respectively)
- •7. Patients with asthma
- •8. Known hypersensitivity to study medication / placebo or respective excipients
- •9. Any contraindications to the study medication
- •10. known immune deficient patients
- •11. Signs or symptoms of fulminant bacterial sinusitis (e.g. fever > 38.5 °C, orbital complications, severe unilateral frontal headache or toothache)
- •12. Severe diseases of liver or kidney
- •13. Severe somatopathic, neurological and / or psychiatric diseases
- •14. Patients with malignant growth processes or cancer treatment within the last five years (head / neck Treatments) and / or within the last 2 years (other body regions) prior to study inclusion.
- •15. Any condition which might interfere with study objectives or that would limit the patients ability to complete the study as judged by the investigator
- •16. History of alcohol or drug abuse
- •Medical history
- •b) Medication
- •1. Treatment with immunosuppressive medication 8 weeks prior to screening and during the study for any condition
- •2. Treatment with systemic or nasal antibiotics or nasal or systemic corticosteroids within the last 30 daysprior to study inclusion
- •3. Systemic antiviral treatment such as aciclovir; zanamivir, or oseltamivir within 30 days prior to visit 1.
- •4. Treatment with alternative medicinal preparations for treatment of common cold like symptoms or with immunomodulating properties, within the last 7 days prior to study inclusion
- •5. Patients requiring antibiotic treatment for any condition at study entry
- •Medical history
- •1. Parallel participation in any other clinical study, participation in another study within less than 6 weeks prior to study entry, or previous participation in this same study
- •2. Pregnant, lactating women or women capable of bearing children rejecting the use of reliable contraceptives (Pearl-lndex < 1)
- •3. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
- •4. Patients in custody by juridical or official order
- •5. Uncooperative patients
- •6. Patients who have difficulties in understanding the language (German) in which the patient information is given
- •7. Patients who are in a dependent relationship with the Sponsor, the investigator, other study team members, or the study center
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