Sublingual Administration of a Polyvalent Mechanical Bacterial Lysate in Patients With Moderate, Severe or Very Severe COPD According to GOLD Classification: a Multicenter, Double Blind, Randomized, Controlled, Phase IV Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 15
- 主要终点
- To demonstrate the clinical efficacy of Ismigen in patients with moderate, severe and very severe COPD (M/S/VS-COPD) according to GOLD classification, in terms of reduction of the number of exacerbations in a 12 month observation period.
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) are characterized by frequent relapses, often resulting from common bacterial infections. Enhancing the immune response in these patients may decrease the frequency of these relapses. The use of a mechanic Polyvalent Bacterial Lysate (PMBL, Ismigen, 13 bacterial strains)may enhance the immune response and therefore help significantly to the control of relapse in these patients.
In the current study the effect of the administration of the PBML to patients older than 40 years, with moderate, severe or very severe COPD, in good or discrete physical condition on the number of relapses in an observation period of 12 months. In addition, the effect of the PMBL on the duration of the interval between relapses, on relapse symptoms, on the use of other drugs, on the number of days of absence of work, on the number of hospitalizations and duration thereof and on potential toxicity of the treatment.
详细描述
Ancillary Study at the center of Genoa:
To investigate in a subgroup of patient, taking part in the AIACE study, the ability of PMBL to induce an Ig response, to modify the NK blood pattern, and to modulate inflammatory parameters (e.g. CRP).
Material & Methods:
30 patients who were enrolled at the Respiratory Department of Genoa University during the AIACE trial and double blind randomly treated with bacterial lysate or placebo, will participate in this ancillary study.
A further informed consent to participate in this laboratory trial will be requested to the patient besides the already ethical procedure approved for the AIACE study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with documented moderate, severe and very severe COPD
- •Age greater than or equal to 40 years.
- •Female patient must be non-lactating and of non-childbearing potential, surgically sterile, or using effective contraception.
- •Patients must have WHO performance status of 0, 1 or
- •Patients must have adequate hematological, renal and liver function as defined by laboratory values below performed within 14 days, inclusive, prior to study randomization.
- •Smokers, ex-smokers can be included but the smoking status is acquired and accurately recorded
- •Absolute neutrophil count (ANC) ≥ 2.0 x 109/l.
- •Platelet count ≥ 100 x 109/l.
- •Hemoglobin ≥ 10 g/dl (> 6.2 mmol/l).
- •Urea and serum creatinine <1.5 times upper limit of laboratory normal (ULN).
- •Total serum bilirubin <1.5 times ULN.
- •ALAT or ASAT <5 times ULN.
- •Alkaline phosphatase <5 times ULN.
- •Gammaglutamyltransferase (GGT) <5 times ULN.
- •LDH <5 times ULN.
- •Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
排除标准
- •Patients who had received any prior antineoplastic drug therapy or immunosuppressive drugs.
- •Patients under continuous treatment with systemic steroids.
- •Presence of severe cardiac disease including uncontrolled angina pectoris and myocardial infarction within 6 months, uncontrolled high blood pressure.
- •Presence of severe respiratory disease as identified from spirometry and/or chest X ray.
- •Presence of any other uncontrolled severe medical condition including active gastroduodenal ulcer, alcohol disorders ( hepatitis, Korsakoff syndrome..), diabetes, active or uncontrolled infection, evolutive intracranial hypertension"
- •Patients pregnant or nursing at the beginning of the study.
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
研究组 & 干预措施
Ismigen
Treatment over 3 successive months. One sublingual tablet every day on the first ten days of each month, followed by twenty days of rest.
干预措施: Ismigen (Biological)
Placebo
Treatment over 3 successive months. One sublingual tablet every day on the first ten days of each month, followed by twenty days of rest.
干预措施: Placebo (Biological)
结局指标
主要结局
To demonstrate the clinical efficacy of Ismigen in patients with moderate, severe and very severe COPD (M/S/VS-COPD) according to GOLD classification, in terms of reduction of the number of exacerbations in a 12 month observation period.
时间窗: 1 year
次要结局
- Effect of Ismigen on the number of hospitalizations.(1 year)
- Effect of Ismigen on the duration of hospitalizations.(1 year)
- Effect of Ismigen on disease symptoms (fever, dyspnoea).(1 year)
- Ability of Ismigen to reduce the use of other drugs (antibiotics, antinflammatory drugs, bronchodilators, mucolytics, etc.) in patients with documented M/S/VS-COPD.(1 year)
- Impact on quality of life assessed with a generic health survey (SF-12) and a specific (CCIQ) instrument.(1 year)
- Effect of Ismigen on the interval between each exacerbation.(1 year)
- Ability of Ismigen to reduce the number of days of absence from work in patients with documented M/S/VS-COPD.(1 year)
- Number of patients with adverse events as a measure of safety and tolerabiity.(1 year)
- Ability of Ismigen (PMBL) to induce immunological and inflammatory modulatory responses(1 year)