A Multi-Center, Open Label Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Ciprofloxacin For Inhalation (CFI) Given Daily For 14 Days To Stable Cystic Fibrosis Patients Ages 6 To 17 With Pseudomonas Aeruginosa
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Serum pharmacokinetics
研究概览
简要总结
This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI) in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection.
详细描述
This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI) in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection. Patients will be enrolled and followed in this study for 1 month. This study will consist of a Screening Phase, a Treatment Phase consisting of a 14 days, and a Follow up Phase consisting of a 14 days Off-treatment Period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 to 17 years of age (inclusive) at Visit
- •Positive sputum culture for P. aeruginosa
- •Clinical diagnosis of CF
- •FEV1 greater than or equal to 40% predicted normal lung function
- •Able to perform spirometry testing reproducibly according to ATS guidelines.
排除标准
- •Use of an investigational agent within 30 days prior to Visit 1 (first dosing visit).
- •History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B. cepacia), within 2 years prior to screening and/or sputum culture yielding B. cepacia at the Screening visit;
- •Use of any nebulized or systemic antibiotics within 14 days prior to Visit 1, other than maintenance oral macrolides that has been consistently used for at least 28 days prior to Visit
- •History of intolerance or hypersensitivity to quinolone or fluoroquinolone class antibiotics
- •History of lung transplantation.
- •AST, ALT or total bilirubin > 3 x upper limit of normal at screening.
- •History of hemoptysis > 30 cc per episode during the 28 days prior to Visit
- •Other present conditions, abnormality in screening laboratory tests or physical examination findings, that in the opinion of the Investigator or Medical Monitor would compromise the safety of the patient or the quality of the data.
研究组 & 干预措施
Ages 6-11 years
干预措施: Antibiotic (Drug)
Ages 12-17 years
干预措施: Antibiotic (Drug)
结局指标
主要结局
Serum pharmacokinetics
时间窗: Day 1
次要结局
- Microbiological efficacy(Day 14)
- Changes in spirometry(Days 1, 7, 14)
- Quality of life (CFQ-R)(Days 1, 7, 14)