EUCTR2006-004167-56-PL进行中（未招募）1 期
Prulifloxacin versus levofloxacin in the treatment of patients with Acute Exacerbations of Chronic Bronchitis (AECB)
A.C.R.A.F. S.p.A.0 个研究点目标入组 300 人开始时间: 2009年11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
- 300
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)Male or female in- and out-patients with age between 40 and 75 years with no limitation of race. Female patients of childbearing potential are required to use an highly effective contraceptive method (implants, injectables, copper and hormonal IUDs, sexual abstinence, vasectomised partner) [CPMC/ICH/286/95] and to have a negative pregnancy test.
- •2)Patients with a diagnosis of Acute Exacerbations of Chronic Bronchitis* characterized by the presence of the following three symptoms, or at least two including purulence:
- •- increased dyspnoea;
- •- increased of sputum volume;
- •- increased of sputum purulence, that had to be confirmed macroscopically by the investigator.
- •* Chronic bronchitis is characterized by cough and excessive secretion of mucus and is diagnosed when patients report production of sputum on most days over at least three consecutive months for 2 or more consecutive years.
- •3)Patients with moderate-to-severe deterioration of lung function, showing a FEV1 value less than or equal to 50% of the predicted value.
- •4)Patients requiring starting concomitant systemic corticosteroids administration (20- 40 mg/day for 7 days), or chronically corticosteroid-treated in which an increase of the daily dosage is required.
- •5)Availability of a valid sputum specimen of broncho-pulmonary origin for microbiological evaluation obtained by either expectoration, suction, bronchoscopy or bronchial lavage. Valid samples will be characterized by < 10 squamous epithelial cells and > 25 polymorph nuclear leucocytes per low-power magnification 100x field.
- •6)Negative chest radiography to rule out pneumonia and any suspicion of tuberculosis.
- •7)Written informed consent to the trial signed and dated by the patient according to the local regulations, obtained prior to all activities related to the trial.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Hypersensitivity or allergy to antibacterial fluoroquinolones and/or to any component of the study medications.
- •2)Underlying asthma.
- •3)Pregnancy and breast feeding.
- •4)History of tendinopathy.
- •5)Recent or past history of psychiatric illness or epilepsy.
- •6)Recent or past history of cardiac disease or rhythm disorders or clinically significant ECG abnormalities.
- •7)Latent or known deficiencies for the glucose-6-phospste dehydrogenase activity.
- •8)Known severe hepatic and/or renal insufficiency (AST, ALT and/or creatinine levels more than twice as high as the Upper Laboratory Norm, ULN). Should laboratory data not be available when treatment is required, the patient may be conditionally enrolled.
- •9)Other lower respiratory tract illness: severe bronchiectasies, cystic fibrosis, or pulmonary malignancy.
- •10)Concurrent infections and /or neoplasm.
- •11)Concomitant treatment with hypoglycemic drugs.
- •12)Patients under treatment with fenbufen and xanthines. Patients treated with xanthines could however be recruited if plasma levels were monitored; if plasma levels exceeded concentrations of 10-15 micrograms/ml, the daily dosages of xanthines should be lowered by the Investigator.
- •13)Treatment with antibiotics or antibacterials within the previous week.
- •14)Treatment with experimental drugs in the previous 4 weeks.
- •15)All changes in lungs suggestive of active or past Tuberculosis
研究者
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