A Pilot Study Assessing the Safety and Efficacy of Pioglitazone as an Anti-inflammatory Agent for the Treatment of CF Lung Disease in Patients With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Sputum TNFα
研究概览
简要总结
Study Hypothesis: Pioglitazone may decrease inflammation in cystic fibrosis lung disease.
Primary outcomes: Markers of inflammation (neutrophils, elastase, cytokines and bacteria)will be measured in induced sputum specimens before and after a 4 week treatment period with pioglitazone in clinically stable CF patients.
详细描述
- Single-center, open label study of pioglitazone in clinically stable patients with mild to moderate CF lung disease
- Induced sputum will be obtained from each subject at enrollment (Baseline) and again following 28 days of pioglitazone treatment (End of Treatment)
- Changes in markers of inflammation in the sputum samples will be assessed
- Safety measures, including complete blood count (CBC), serum chemistry, Erythrocyte sedimentation rate (ESR), C-Reactive Protein (CRP), urinalysis and spirometry, will also be assessed
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This was open-label and no one was masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female >= 28 years of age
- •Confirmed diagnosis of cystic fibrosis
- •Forced Expiratory Volume in 1 second (FEV1) >= 40% predicted
- •Clinically stable
- •Ability to reproduce spirometry
- •Ability to understand and sign the informed consent
排除标准
- •Use of an investigational agent within 4-week period prior to Visit 1
- •Chronic daily use of ibuprofen or other NSAIDS
- •Chronic daily use of insulin,oral diabetic agents or oral hypoglycemic agents
- •History of hypersensitivity to beta agonists
- •History of hypersensitivity to glitazones
- •Oxygen saturation<92%
- •Pregnant, breastfeeding or unwilling to practice acceptable birth control
- •History of hemoptysis >30cc per episode within 30 days prior to Visit 1
- •Significant history of hepatic, cardiovascular, renal,neurologic, hematologic or peptic ulcer disease
- •Serum Glutamic-Oxaloacetic Transaminase (SGOT)/(Serum Glutamic Pyruvic Transaminase (SGPT) >3 times the upper limit of normal at screening, documented biliary cirrhosis,or portal hypertension
- •Creatinine > 1.8 mg/dL at screening
- •Inability to swallow pills
- •Presence or abnormality that in the opinion of the investigator would compromise the safety or the quality of the data
- •Subjects who have routinely taken ibuprofen or other NSAIDS; prednisone or other systemic corticosteroids, or insulin, or oral diabetic agents within 4 weeks prior to visit 1 or who have taken these medications as needed within 72 hours prior to visit one will be excluded
研究组 & 干预措施
Pioglitazone
All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily Other names: Actos, Takeda
干预措施: pioglitazone (Drug)
结局指标
主要结局
Sputum TNFα
时间窗: Day 0 and Day 29
The concentration of Tumor Necrosis Factor-α (TNFα) log 10 (pg/mL)
Sputum Neutrophil Count
时间窗: Day 0 and Day 29
sputum neutrophils log 10 (cells/mL)
Sputum White Cell Count
时间窗: Day 0 and Day 29
The total number of white cells log 10 cells/mL
Sputum Neutrophil Percent
时间窗: Day 0 and Day 29
Neutrophils as a percent of the total white cells.
Sputum Active Elastase
时间窗: Day 0 and Day 29
Log 10 of Concentration of active Elastase in mcg/mL
Sputum IL-8
时间窗: Day 0 and Day 29
Concentration of Interleukin-8 log 10 (pg/mL)
Sputum IL-1ß
时间窗: Day 0 and Day 29
The concentration of Interleukin-1ß (IL-1ß) log 10 (pg/mL)
Sputum IL-6
时间窗: Day 0 and Day 29
The concentration of Interleukin-6 (IL-6) log 10 (pg/mL)
次要结局
未报告次要终点
研究者
Michael W. Konstan
Professor of Pediatrics
University Hospitals Cleveland Medical Center