NCT00809094已完成2 期
A Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 11
- 主要终点
- Change in the Logarithm of the Level of Human Neutrophil Elastase (HNE) Activity Measured in Sputum
研究概览
简要总结
This Phase IIB proof-of-concept study would examine the effects of an investigational product called N-acetylcysteine (NAC) on the basic processes that cause inflammation in CF lung disease. We hope to learn more about the causes of lung disease in cystic fibrosis by studying the characteristics of the inflammation in the lungs of patients who have CF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 7 years of age or older
- •Diagnosis of CF based upon the following criteria:
- •One or more clinical features characteristic of CF AND (b or c)
- •Positive sweat test > 60 mEq/L by quantitative pilocarpine iontophoresis
- •A genotype with two identifiable mutations consistent with CF
- •Written informed consent (and assent when applicable) obtained from subject or subject's legal representative
- •Clinically stable with no evidence of acute upper or lower respiratory tract infection within 4 weeks prior to enrollment
- •Stable mild or moderately severe lung disease defined by an FEV1 > or = 40% and < or = 85% predicted for age based on the Wang (males < 18 years, females < 16 years) or Hankinson (males > or = 18 years, females > or = 16 years) standardized equations
- •Able to tolerate sputum induction with 3% hypertonic saline and to expectorate
- •Able to perform repeatable, consistent efforts in pulmonary function testing
- •Weight > or = 25 kg at time of enrollment
- •Females of child bearing potential must be willing to use birth control (IUD, oral, transdermal, or parenteral contraceptives; abstinence)
排除标准
- •Clinically significant liver enzymes (AST, ALT or GGT) > 2.5 times the upper limit of normal at screening
- •History of ABPA, unless have evidence of a stable IgE (< 5% increase compared to previous test) for 6 months prior to enrollment
- •Current or history of rheumatic or collagen vascular disorders
- •Use of NSAIDS other than for chronic therapy within 1 week prior to enrollment
- •Initiation of chronic therapy with ibuprofen, azithromycin, TOBI® or Aztreonam within 6 weeks prior to enrollment
- •Consumption or inhalation of antioxidants (including NAC, GSH, Immunocal, Nacystelyn, pentoxyfilline) within 6 weeks prior to enrollment
- •Use of oral or IV corticosteroids within 4 weeks prior to enrollment
- •Use of acetaminophen within 3 days prior to enrollment
- •Unable to forego during the study:
- •Vitamin E: more than 400 IU/day for subjects < or = 12 years of age and 800 IU/day for subjects > 12 years of age
- •Vitamin C: more than 0.5 gm/day
- •More than two alcoholic drinks per day
- •Known hypersensitivity to oral PharmaNAC®
- •Current cigarette consumption
- •Pregnant or breastfeeding
- •Subject unlikely to complete the study as determined by the Investigator
- •Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the subject
- •Participation in trials for other anti-inflammatory or therapeutic investigational drugs within 6 weeks prior to enrollment
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo was administered oral tablet TID for 24 weeks.
干预措施: Placebo (Drug)
N-Acetylcysteine
Active Comparator
Participants received 900 mg of oral N-acetylcysteine TID for 24 weeks.
干预措施: N-acetylcysteine (NAC) (Drug)
结局指标
主要结局
Change in the Logarithm of the Level of Human Neutrophil Elastase (HNE) Activity Measured in Sputum
时间窗: From enrollment to end of the 24-week trial
(change in log10 HNE in the active treatment group) - (change in log10 HNE in the placebo group)
次要结局
- Change in FEV1 (Percent of Predicted for Age)(From enrollment to the end of the 24-week trial)
- FEV1 (L)(Baseline to end of study (24 weeks))
- FEF 25-75% (L/Sec)(Baseline to end of study (24 weeks))
- FEF 25-75% (Percent of Predicted)(Baseline to 24 weeks)
研究者
研究点 (11)
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