Study of Ibuprofen to Preserve Lung Function in Patients With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
研究概览
简要总结
OBJECTIVES:
I. Determine the effect of different doses of ibuprofen on neutrophil (polymorphonuclear leukocyte; PMN) delivery to a mucosal surface (the oral mucosa) in patients with cystic fibrosis and healthy controls.
II. Determine the duration of effect (and possible rebound effect) of ibuprofen on PMN delivery to a mucosal surface in these patients.
详细描述
PROTOCOL OUTLINE:
This is an open label study. Patients are randomized into 5 arms, each consisting of 10 healthy volunteers and 5 patients with cystic fibrosis, based on the amount of ibuprofen received during the treatment period.
The study period lasts for at least 15 days and consists of 3 periods: baseline (days 1-3), treatment (days 3-12), and recovery (days 13-15 or longer). During the treatment period patients receive ibuprofen orally every 12 hours (except for a control arm that receives no ibuprofen).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Confirmed diagnosis of cystic fibrosis (CF) based on: Sweat chloride greater than 60 mEq/L AND Typical pulmonary and/or gastrointestinal manifestation of CF OR Healthy volunteers
- •-Prior/Concurrent Therapy--
- •At least 30 days since medications with anti-neutrophil or anti-inflammatory effect (e.g., aspirin, nonsteroidal anti-inflammatory drugs [NSAIDs], corticosteroids, macrolide antibiotics)
- •-Patient Characteristics--
- •Age: Patients with cystic fibrosis (CF): 5 and over; Healthy volunteers: 18 and over
- •Hematopoietic: No significant history of hematologic disease
- •Hepatic: No significant history of hepatic disease
- •Renal: No significant history of renal disease
- •Cardiovascular: No significant history of cardiovascular disease
- •Pulmonary: See Disease Characteristics
- •Neurologic: No significant history of neurologic disease
- •Other: Not pregnant; No significant history of peptic ulcer disease; Patients with CF free of any acute illness within 14 days; No prior hypersensitivity to any NSAID
排除标准
- 未提供