Phase II Study of Inhaled CO for the Treatment of Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 8
- 主要终点
- Serum MMP7 Level
研究概览
简要总结
The purpose of this study is to determine whether low concentration inhaled carbon monoxide is effective in treating idiopathic pulmonary fibrosis.
详细描述
Idiopathic pulmonary fibrosis (IPF) is an interstitial lung disease characterized by destruction of normal epithelial structure, proliferation of fibroblasts, and deposition of connective-tissue matrix proteins. There are currently no effective therapies for IPF. Over the past two decades, preclinical studies of inhaled low dose carbon monoxide (CO) have shown that this biologically active diatomic gas possesses properties that would make it a viable novel therapy for IPF. CO therapy has been well tolerated in Phase I and Phase II human trials to date. This phase II study is designed to investigate whether IPF patients show evidence of decreased peripheral blood levels of matrix metalloproteinase-7 (MMP7) and stability of secondary indicators of disease progression after 3 months of inhaled therapy.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults above the age of 18 and equal to or below the age of 85
- •Diagnosis of IPF by biopsy or
- •American Thoracic Society (ATS)/European Respiratory Society (ERS)/ Latin American Thoracic Association (ALAT) Guidelines (Am J Respir Crit Care Med Vol
- •pp 788-824,2011)
- •Forced vital capacity (FVC) greater than or equal to 50% predicted, greater than or equal to one month off all medications prescribed for IPF
排除标准
- •Evidence of active infection within the last month
- •Significant obstructive respiratory defect
- •Supplemental oxygen required to maintain an oxygen saturation over 88% at rest
- •History of myocardial infarction within the last year, heart failure within the last 3 years or cardiac arrhythmia requiring drug therapy
- •History of smoking within 4 weeks of screening
- •Pregnancy or lactation
- •Participation in another therapeutic clinical trial
研究组 & 干预措施
carbon monoxide inhalation
The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.
干预措施: inhaled carbon monoxide (Drug)
Oxygen 21%
干预措施: Oxygen (Other)
结局指标
主要结局
Serum MMP7 Level
时间窗: Baseline to Week 12
The primary study endpoint was the change in MMP7 serum concentration (ng/ml) from baseline to 12 weeks. Serum MMP7 concentrations in peripheral blood are easily measureable and reflect changes in the alveolar microenvironment. Thus, we have chosen to study mean serum MMP7 concentrations after three months of CO treatment as a surrogate biomarker of the effect of inhaled CO administration on disease progression.
次要结局
- Total Lung Capacity % Predicted Values (TLC)(Baseline to Week 12)
- St George's Respiratory Questionnaire(Baseline to Week 12)
- Six Minute Walk Distance(Baseline to Week 12)
- Diffusing Capacity for Carbon Monoxide (DLCO) % Predicted Values(Baseline to Week 12)
研究者
Ivan O. Rosas
Overall Principle Investigator
Brigham and Women's Hospital