NCT00534625已完成2 期
Phase 2 Study of the Assessment of Pulmonary Function, Safety, Tolerability, and PK of Zileuton Injection in Patients With Chronic Stable Asthma
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
- 36
- 主要终点
- Effect on pulmonary function
研究概览
简要总结
A single intravenous injection of zileuton (150 or 300 mg) will be administered to patients with stable asthma. The goals will be to determine if zileuton i.v. can produce a rapid increase in FEV1/PEFR and when this effect can be seen. The safety of this route of administration of zileuton will also be studied. PK will be obtained in a population based method.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 12 years of age or older
- •Diagnosis of asthma by current ATS guidelines
- •FEV1 of 4-80%.
- •Reversibility of at least 13% after bronchodilator treatment
- •Must be willing to with hold SABA for 6 hours and ICS for 24 hours prior to treatment.
- •Informed consent
排除标准
- •Females of child bearing potential unless using birth control
- •Uncontrolled systemic disease
- •Known hypersensitivity to zileuton or components of zileuton injection.
- •Upper or lower respiratory tract infection within the last 2 weeks
- •Admission to hospital or ER visit for asthma exacerbation within the last 3 months
- •Course of oral or parenteral steroids within the last 3 months
- •Current smoker or H/O > 15 pack years
- •Creatinine > 1.5 x ULN
- •ALT > 3 x ULN
- •BP < 100 (systolic)
- •H/O alcohol or drug abuse
- •Patients taking Xolair, theophylline, montelukast, zafirlukast, nedocromil, cromolyn sodium, Zyflo (within the past 7 days), warfarin, propranolol, inhaled anti-cholinergics, or LABA.
- •Pregnant or breast feeding females
- •Current participation or participation in an experimental drug study within 30 days.
研究组 & 干预措施
1
Placebo Comparator
干预措施: placebo (Drug)
2
Experimental
150 mg zileuton by intravenous injection
干预措施: zileuton (Drug)
3
Experimental
300 mg zileuton by intravenous injection
干预措施: zileuton (Drug)
结局指标
主要结局
Effect on pulmonary function
时间窗: Within 0-12 hours after single dose
次要结局
- Safety assessments(Within 0-36 hours after single dose)
研究者
相似试验
已完成
2 期
Zileuton for the Treatment of Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisNCT00262405University of Michigan44
终止
2 期
Safety and Efficacy of USB002 for Respiratory Distress Due to COVID-192019 Novel Coronavirus InfectionCOVID-19 Virus InfectionSARS Coronavirus 2 InfectionSARS-CoV-2 InfectionRespiratory Distress Syndrome, AdultAdult Respiratory Distress SyndromeNCT04778059US Biotest, Inc.21
已完成
2 期
A Study Evaluating the Effect of Inhaled PT007(AS MDI) Versus Placebo MDI and Ventolin Evohaler on Lung Function in Adult Participants With AsthmaAsthmaNCT06644924AstraZeneca118
已完成
2 期
Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy SurgeryAcute PainNCT00877799Cara Therapeutics, Inc.114
已完成
2 期
Study of BSF 208075 Evaluating Exercise Capacity in Patients With Pulmonary Arterial HypertensionPulmonary HypertensionNCT00046319Gilead Sciences60