Antileukotriene Therapy for COPD Exacerbations
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 119
- 试验地点
- 14
- 主要终点
- Length of Hospital Stay
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a long-term lung disease that is caused by cigarette smoking or by breathing in other lung irritants, including pollution, dust, or chemicals. The purpose of this study is to evaluate the effectiveness of zileuton, a medication that is used to control asthma symptoms, at reducing the length of a hospital stay for adults who are hospitalized for a COPD exacerbation, or worsening of COPD symptoms.
详细描述
COPD is a disease in which the lung airways are partly damaged and obstructed, making it difficult to breathe. COPD is the fourth leading cause of death in the United States. Symptoms include coughing, excess mucus production, shortness of breath, wheezing, and chest tightness. Treatment usually includes inhaled bronchodilator or steroid medications that work by relaxing the muscles around the lung airways and reducing inflammation. Zileuton, a medication that is used to prevent asthma symptoms, may be beneficial in treating people who experience COPD exacerbations. Zileuton works by blocking the formation of substances that cause inflammation, fluid retention, and constriction in the lungs. The purpose of this study is to evaluate the effectiveness of zileuton at reducing the length of a hospital stay for adults who are hospitalized for a COPD exacerbation.
This study will enroll adults who are admitted to the hospital due to severe COPD symptoms. Participants will be randomly assigned to receive either zileuton or placebo four times a day for up to 14 days. While in the hospital, lung function testing and urine collection will occur. Study visits will occur at Days 14 and 30, and will include lung function testing, a medical history review, and a study drug adverse effects review.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to the hospital for a COPD exacerbation
- •FEV1 less than 60% of predicted level
- •At least 10 pack years of smoking
排除标准
- •Any uncontrolled systemic disease
- •Known hypersensitivity to zileuton
- •Lobar pneumonia or pulmonary edema
- •Interstitial lung disease
- •Medical condition that is likely to limit survival to less than 30 days at the time of study entry
- •History of liver disease
- •Current use of theophylline
- •Participation in another clinical trial in the COPD Clinical Research Network
- •Incarceration
- •Institutionalization
- •History of a suicide attempt
- •Prior inpatient admission for a psychiatric disorder
- •Bipolar disorder
研究组 & 干预措施
Zileuton
Zileuton (Zyflo, 600 mg 4 times a day)
干预措施: Zileuton (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Length of Hospital Stay
时间窗: Measured at Day 30
Admission will begin at the time the subject has been admitted to an inpatient service. Length of Stay (LOS) will be recorded in days. The LOS will be based on the number of days spent in an acute medical ward or in the ICU. Subjects that are admitted and discharged in the same 24 hour period will be recorded as a LOS of 1 day, as will subjects discharged in the ensuing 24 hour period. LOS's greater than 10 days will be truncated to 10 days.
次要结局
- Change in FEV1% Predicted(Measured at Baseline and Day 30)
- Change in FEV1/FEV6 Levels(from baseline to day of discharge)
- Treatment Failure(Baseline to day 30 visit)
- Health-related Quality of Life(Change from Baseline and 1 Month)
- Change in Urinary Leukotriene (LTE4) Levels(Baseline and 72 hours later)