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临床试验/EUCTR2017-003044-20-DE
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

Cassella-med GmbH & Co. KG0 个研究点目标入组 210 人开始时间: 2017年8月24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)
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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A study of the effectiveness and safety of Cineole... | 临床试验