Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
OBJECTIVES: I. Determine the safety and efficacy of tobramycin in patients with cystic fibrosis who are chronically colonized with Pseudomonas aeruginosa.
II. Determine whether this treatment produces tobramycin-resistant bacteria at a frequency different from the placebo group and whether the emergence of resistance is associated with a lack of clinical response.
详细描述
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.
Patients receive tobramycin or placebo by inhalation twice daily for 28 days followed by 28 days of rest. This treatment is repeated twice, for a total of 3 courses of therapy.
Patients are followed every 2 weeks for the first 8 weeks, then every 4 weeks, and then at 4 weeks after the last treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Documented cystic fibrosis with Pseudomonas aeruginosa present in a sputum or throat culture within 6 months prior to screening
- •Sweat chloride at least 60 mEq/L
- •-Prior/Concurrent Therapy--
- •At least 14 days since prior intravenous or aerosolized tobramycin or other antipseudomonal antibiotic
- •At least 4 weeks since prior administration of any investigational drug
- •No concurrent antibiotics by aerosol
- •-Patient Characteristics--
- •Creatinine less than 2 mg/dL
- •BUN less than 40 mg/dL
- •No proteinuria of 2+ or greater
- •FEV1 at least 75% and at least 25% of predicted
- •Room air oximetry at least 88% saturation
- •Able to perform pulmonary function tests
- •No hemoptysis of 60 mL or greater within 30 days prior to study
- •No abnormal chest X-ray
- •Not pregnant
- •Fertile females must use effective contraception
- •No history of positive culture with Burkholderia cepacia
- •No history of glucose-6-phosphate dehydrogenase deficiency
- •No known local or systemic hypersensitivity to aminoglycosides, albuterol, or other beta-2 agonists
排除标准
- 未提供