PER-066-00已完成未知
A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, COMPARATIVE PHASE III STUDY OF ORAL BMS-284756 VERSUS ORAL AZITHROMVCIN IN THE TREATMENT OF ACUTE EXACERBATION OF CHRONIC BRONCHITIS
BRISTOL MYERS SQUIBB PERU S.A.,0 个研究点目标入组 0 人开始时间: 2000年11月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Men or women 18 years of age or older, in whom oral therapy is indicated;
- •With a diagnosis of chronic bronchitis (that is, having chronic cough and sputum production most days for three consecutive months, for> two consecutive years), and clinical evidence of EABC proven by the following main symptoms:
- •- Production of purulent sputum, determined in a preliminary sample of sputum smear by the presence of> 25 polymorphonuclear leukocytes (PMLN) per low power field;
- •Presence of two or more of the following signs and symptoms:
- •increased cough and / or dyspnea,
- •increased sputum volume,
- •increased sputum purulence.
- •The subject or his legally authorized representative have given their informed consent in writing.
- •Women of childbearing age should have a negative pregnancy test in serum or urine (minimum sensitivity of 25 IU / L or equivalent units of HCG) made within 48 hours immediately prior to the start of study drug administration.
排除标准
- •Diagnosis of pneumonia confirmed by the presence of new pulmonary infiltrates on chest radiography;
- •Previous diagnosis of immunological disease (for example, AIDS, current neutrophil count <1000 / mm 3);
- •Prior diagnosis of conditions that tend to mimic or complicate the course and evaluation of the infectious process (for example, active bronchiectasis, active pulmonary malignancy, cystic fibrosis, ciliary immobilization syndrome);
- •Have received therapy with systemic antibiotics in the seven days immediately prior to randomization, or the probability of receiving other systemic antibiotics during participation in the study;
- •Pregnancy and / or lactation;
- •Malabsorption syndromes or other gastrointestinal disorders that could affect the absorption of the medication;
- •History of serious hypersensitivity reaction (eg, urticaria, anaphylaxis) to any quinolone or macrolide compound;
- •Known renal insufficiency, eg, serum creatinine> 2.0 mg / dL (176.7 mmol / L) or requiring renal dialysis;
- •Current clinically significant liver disease or known values of
- •ALT and / or AST, and / or total bilirubin> 3 times the normal maximum limit.
- •Use of a research agent concomitantly or within 30 days prior to admission in this study;
- •Previous admission in any study with BMS-284756;
- •Presence of any disorder or disease that may interfere with the evaluation of the study medication and / or due to which, in the opinion of the Investigator, it would not be appropriate to admit the subject in the study;
- •Subjects receiving terfenadine, cisapride or astemizole.
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