EUCTR2018-001395-37-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 bronchitis. A multicenter,randomized, double-blind, placebo-controlled, parallel-group phaseIV clinical trial. - ANGOCOUGH
Repha GmbH0 个研究点目标入组 380 人开始时间: 2018年6月5日最近更新:
适应症
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) bronchitis:
- •- characterized by the main symptoms with an BSSinv Score = 5
- •- symptoms occured = 48 h 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
- •a) Diseases
- •1. Chronic Bronchitis (i.e. all forms and causes of persistent chronic bronchitis)
- •2. Patients with severe respiratory infections, requiring treatment with antibiotics
- •3. Diagnosed Asthmatics or patients with diagnosed allergic bronchial Asthma (severity in adults: ligth to severe according to S2k guidance for asthmatics diagnosis), diagnosed bronchietktase, and diagnosed chronic obstructive pulmonary disease (COPD, GOLD I-IV)
- •4. Cystic fibrosis
- •5. Known hypersensitivity to study medication / placebo or respective excipients
- •6. Any contraindications to the study medication
- •7. known immune deficient patients, known progressive autoimmune diseases
- •8. Signs or symptoms of fulminant bacterial Bronchitis (fever > 38.5°C)
- •9. Diagnosed severe heart diseases NYHA class >/= 2(e. g. myocardial infarction, coronary heart disease)
- •10. Diagnosed severe diseases of the liver (e. g. fatty liver, liver cirrhosis)
- •11. Diagnosed severe diseases of the kidney (serum creatinine > 1.4 mg/dL)
- •12. Severe somatopathic, neurological and / or psychiatric diseases making it difficult for the Patient to decide to consent to Trial participation
- •13.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 with further hazardous potential
- •14. Any condition which might interfere with study objectives or that would limit the patients ability to complete the study as judged by the
- •investigator
- •15. Exisiting habits of alcohol or drug abuse
- •b) Medication
- •1. Treatment with immunosuppressive medication 8 weeks prior to screening
- •2. Treatment with systemic or inhalative antibiotics or nasal or systemic / inhalative corticosteroids within the last 30 days prior to study inclusion
- •3. Systemic or inhalative antiviral treatment such as aciclovir; zanamivir, or oseltamivir within 30 days prior to visit 1.
- •4. Treatment with registered alternative medicinal preparations for treatment of common cold like symptoms or with immunomodulating properties,
- •within the last 7 days prior to study inclusion
- •5. Treatment with bronchodilatators within the last 7 days prior to study enrolment
- •6. Treament with expectorants or antitussives within the last 3 days before study enrolment
- •7. Patients requiring antibiotic treatment for any condition at study entry
- •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
研究者
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