NCT00862641已完成4 期
A Phase 4, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease (COPD).
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,009
- 主要终点
- Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment
研究概览
简要总结
This study is intended to determine the safety and tolerance of regadenoson in subjects with asthma or chronic obstructive pulmonary disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has asthma or stable chronic obstructive pulmonary disease (COPD).
- •Subject has a diagnosis of coronary artery disease (CAD) or risk factors for CAD as determined by a current medical diagnosis of at least 2 of the following conditions: Type 2 diabetes, hypertension, hypercholesterolemia, current or history of cigarette smoking (minimum 10 pack-years exposure) or obesity Body Mass Index (BMI > 30).
- •Subject must abstain from smoking 3 hours prior and 8 hours post study drug administration.
- •Subject must abstain from any intake of foods and beverages containing a methylated xanthine derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson.
- •Subject is able to safely abstain from theophylline for 12 hours prior to the Day 1 visit, as determined by the Investigator
- •Asthma subject's frequency and severity of symptoms have remained unchanged within 30 days prior to study drug administration
- •Asthma subject has FEV1 ≥60% predicted
- •COPD subject has FEV1/FVC < 0.70
排除标准
- •Female subject who is pregnant, lactating or of childbearing potential who refuses to use a medically acceptable form of contraception until the Follow-Up visit is complete.
- •Subject started on a course of corticosteroids, steroid combination with long-acting Beta2-agonist (LABA) (oral or inhaled) or anticholinergic, or has undergone a change in dose of such medications ≤ 30 days prior to study drug administration (subject on a stable dose of such medications for > 30 days prior to study drug administration is allowed).
- •Subject started leukotriene antagonists (e.g., montelukast), cromones (e.g., cromolyn sodium) or 5-lipoxygenase antagonists (e.g. zileuton or zyflo) or has undergone a change in dose of medications in these drug classes ≤ 7 days prior to study drug administration (subject on a stable dose of these medications for > 7 days prior to study drug administration is allowed).
- •Subject has a history of second or third degree heart block or sinus node dysfunction unless the subject has a functioning pacemaker.
- •Subject has symptomatic hypotension (temporary and reversible conditions that no longer exist are allowed).
- •Subject is allergic or intolerant to aminophylline.
- •Subject has had a respiratory infection within 2 weeks prior to randomization.
- •Subject has had surgery within 3 months prior to randomization.
研究组 & 干预措施
Placebo - Asthma
Placebo Comparator
Matching intravenous (IV) bolus injection, subjects with Asthma
干预措施: Placebo (Drug)
Regadenoson - Asthma
Experimental
0.4mg / 5mL intravenous bolus injection, subjects with Asthma
干预措施: Regadenoson (Drug)
Placebo - COPD
Placebo Comparator
Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
干预措施: Placebo (Drug)
Regadenoson - COPD
Experimental
0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
干预措施: Regadenoson (Drug)
结局指标
主要结局
Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment
时间窗: 2 Hours post dose
FEV1 data was obtained by spirometry measures.
次要结局
- Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration(Within 24 Hours of study drug administration)
- Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values(Baseline and Hour 2)
- Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted(Baseline and Hour 2)
- Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC)(Baseline and Hour 2)
- Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio(Baseline and Hour 2)
- Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry(Baseline and Hour 2)
- Percentage of Selected Respiratory Adverse Events(Within 24 Hours of study drug administration)
研究者
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