EUCTR2017-003044-20-DE进行中(未招募)1 期
A Randomised, Double-blind, Placebo-controlled, Multi-centre Clinical Study to Investigate the Efficacy and Safety of Three Doses of Cineole in Subjects with Severe Acute Bronchitis with or without Associated Common Cold
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 210
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. Age between 18 and 65 years
- •2. Acute bronchitis since = 48 hours, with or without associated common cold
- •3. Women of childbearing potential are allowed only with negative pregnancy test and effective contraception
- •4. Subjects able to follow the instructions given by the investigator
- •5. Signed informed consent
- •6. BSS > 12, indicating severe or very severe bronchitis.
- •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 205
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Chronic bronchitis (WHO Definition) and chronic obstructive pulmonary disease (COPD)
- •2. Bronchial asthma
- •3. Allergic rhinitis
- •4. Chronic rhinitis with or without nasal polyp(s)
- •5. Cystic fibrosis
- •6. Pneumonia and/or indication for treatment with antibiotics
- •7. Pertussis and/or pseudo-croup
- •8. Subjects treated with antibiotics, glucocorticosteroids (systemic or per inhalation), ß2-mimetics, theophylline, expectorants/mucolytics, antitussives, cineole, or other etheric oils (systemic or per inhalation) within 7 days prior to study start or at the time of study start
- •9. Known hypersensitivity to cineole or any of the other compounds of Soledum® Kapseln/ Soledum® Kapseln forte
- •10. Known serious concomitant disease that can influence the course of the bronchitis
- •11. Clinically relevant renal and/or liver diseases
- •12. Smoking at the time of enrolment into the trial or in the last 6 months prior to the enrolment into the trial
- •13. Immunosuppressive states, e.g. malignancy, autoimmune diseases, AIDS
- •14. Pregnancy, lactation. Women without reliable contraception
- •15. Dependency from alcohol or drugs
- •16. Insufficient knowledge of local language endangering compliance
- •17. Subjects participating in another study or who participated in clinical studies within the last 30 days
研究者
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