Pilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary Fibrosis
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Changes in Pulmonary function - DLCO
研究概览
简要总结
This study plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. The study will also create a bank of data, blood, and sputum from IPF patients for future research.
详细描述
This study plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. The study will also create a bank of data, blood, and sputum from IPF patients for future research.
NAC is a medication used to loosen thick mucus. NAC was initially licensed for use in 1968. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system, and it is available as a generic medication and is not very expensive. Inhaled NAC has been used as a mucus-dissolving therapy in respiratory conditions with excessive and/or thick mucus production.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed by study team with expertise in IPF utilizing standard ATS/ERS definition of "probable" or "definite" IPF
- •DLCO >50% predicted
- •FVC >60% predicted
- •FEV1/FVC > 0.7
排除标准
- •History of bronchospasm (requiring treatment)
- •Current acute exacerbation of their IPF disease
- •Current smoker
- •Supplemental O2 requirement > 4 liters/min via nasal cannula
- •History of asthma, COPD, coronary artery disease, or cancer
- •Currently using NAC, hypertonic saline, or DNase (dornase alfa) inhalation therapy
研究组 & 干预措施
N-acetyl cysteine then placebo
This arm will receive NAC followed by placebo
干预措施: N-acetyl cysteine then Placebo (Drug)
Placebo then N-acetyl cysteine
This arm will receive placebo followed by NAC
干预措施: Placebo then N-acetyl cysteine (Drug)
结局指标
主要结局
Changes in Pulmonary function - DLCO
时间窗: Baseline, week 10, and week 18
Measure changes in percent predicted DLCO
Changes in Pulmonary function - FVC
时间窗: Baseline, week 10, and week 18
Measure changes in percent predicted FVC
次要结局
未报告次要终点