EUCTR2013-001940-71-GB进行中（未招募）1 期
A Randomized, Placebo Controlled, Double Blinded, Mechanistic trial to investigate the effects of Broncho-Vaxom (OM-85 BV) on the innate immune system in patients with COPD - OM-85-BV Mechanistic study in COPD
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- OM Pharma SA
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. Provision of written informed consent prior to any study procedures
- •2. Males and Females aged =40
- •3. Confirmed spirometric evidence of mild to very severe COPD (stage I to IV) according to the WHO GOLD criteria; FEV1/FVC <70%
- •4. Current or ex-smoker, with >10PYH (a pack year is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked eg. 10PYH is equal to smoking 20 cigarettes per day for 10 years or 40 cigarettes per day for 5 years)
- •5. Vaccinated against seasonal influenza >7 days prior to enrolment
- •6. History of Chronic Bronchitis
- •7. Exacerbator phenotype – defined as 1 or more treated or untreated acute exacerbations of COPD, with infective component based on symptoms recorded on the patient’s diary card in the previous 12 months, appropriately documented in patients’ medical files
- •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 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. Suffering from asthma
- •2. Any known neoplasia or malignancy
- •3. Other significant respiratory disease such as primary bronchiectasis or mucoviscidosis
- •4. Known chronic systemic infections or inflammatory conditions like Rheumatoid arthritis, Lupus or any other auto-immune disease
- •5. Previous organ transplantation
- •6. Myocardial infarction or cerebrovascular accident within the last 6 months prior to study enrolment
- •7. Suffering from any respiratory infections within 4 weeks prior to study enrolment
- •8. Any major surgery within the last 3 months prior to study enrolment
- •9. Treatment with the following medications:
- •a. antibiotics and systemic and oral steroids (e.g., oral prednisolone) within 4 weeks before Visit 1,
- •b. oral vaccination with live vaccine within 4 weeks before Visit 1,
- •c. long-term azithromycin therapy within 3 months before Visit 1,
- •d. previous and/or concomitant immunosuppressive or immunostimulating therapy within 3 months before Visit 1
- •10. Known allergy or previous intolerance to study medication
- •11. Females who are pregnant or breast feeding
- •12. Females of childbearing potential unwilling to use sufficiently reliable method of contraception for the period of the clinical trial
- •13. Unable to follow instructions and unreliable patients including non-compliant patients, patients with known alcoholism or drug abuse or with a history of a serious psychiatric disorders as well as patients unwilling to abide by the requirements of the protocol, i.e. unable to complete a patient diary.
- •14. Any other clinical conditions, that in the opinion of the investigator, would not allow safe completion of the clinical study
- •15. Not willing or unable to give written informed consent
- •16. Currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening, or receiving other investigational agent(s).
研究者
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