A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of JNJ-18054478 in Subjects With Asthma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 26
- 主要终点
- The percent change from the beginning of the study in Forced Expiratory Volume in one Second (FEV1) after 12 weeks on study drug.
研究概览
简要总结
The purpose of this study is to assess the effectiveness of JNJ-18054478 measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy in patients with persistent asthma.
详细描述
Asthma is one of the most common chronic diseases worldwide. This is a randomized (study medication assigned by chance), double-blind study (neither the physician or the patient knows which drug they are receiving, active or placebo) to Investigate the effectiveness and safety of 12 weeks of dosing with JNJ-18054478 (300 mg taken orally once daily) compared with placebo in patients with persistent asthma. The hypothesis is that the study drug will be more effective in treatment of asthma than placebo as measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy, without any significant adverse events. Safety evaluations will include, monitoring for adverse reactions, clinical laboratory tests of blood and urine, ECGs to monitor the cardiovascular system, vital signs and physical examinations. Patients will take three capsules (100 mg) of JNJ-18054478 orally once daily for 12 weeks or placebo for the same period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically confirmed diagnosis of persistent asthma
- •Able to demonstrate reversibility of at least 12% with albuterol inhalation
- •Use of short-acting b-2 agonists for rescue >= 5 times within 2 weeks prior
- •Able to produce an FEV1 between 45 and 85% of predicted
- •Willing to perform study procedures for about 14 weeks.
排除标准
- •Use of inhaled corticosteroids within 4 weeks
- •Use of oral/parenteral corticosteroids within 8 weeks
- •Use of long-acting beta-2 agonists or montelukast within 2 weeks
- •History of life-threatening asthma attack within 3 months
- •Female of child bearing potential.
研究组 & 干预措施
002
sham comparator 3(100 mg) tablets once daily for 12 weeks
干预措施: sham comparator (Drug)
001
JNJ-18054478 3(100 mg) tablets once daily for 12 weeks
干预措施: JNJ-18054478 (Drug)
结局指标
主要结局
The percent change from the beginning of the study in Forced Expiratory Volume in one Second (FEV1) after 12 weeks on study drug.
时间窗: 12 weeks
次要结局
- The change in FEV1 after 1, 2, 4, 6, 8 and 10 weeks therapy. The change in symptoms and use of asthma rescue medication. The number of asthma attacks compared to placebo. The safety, tolerability, and blood and urine levels of JNJ-18054478(12 weeks)