A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Exploratory Study of the Safety and Efficacy of JNJ-39758979 in the Treatment of Adults With Persistent Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 主要终点
- Percent change from baseline to Week 12 in pre-bronchodilator percent predicted Forced Expiratory Volume in 1 second (FEV1) value
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of once daily oral administration of JNJ-39758979 in the treatment of adults (18 to 65 years of age) with persistent asthma.
详细描述
This is a multicenter, double-blind (neither physician nor participants knows the treatment that the participant receives), randomized (study medication is assigned by chance), placebo-controlled (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study), parallel group (each group of participants will be treated at the same time), exploratory study (JNJ-39758979 is introduced in participants with asthma for the first time). This study consists of 4 phases: screening phase (4 weeks prior to the start of the run-in period), placebo run-in phase (2 weeks prior to the start of treatment phase), double-blind treatment phase (12 weeks), and posttreatment phase (5 weeks). Approximately 100 participants will be randomly allocated to 1 of 2 treatment groups: Treatment A (participants will receive JNJ-39758979 once daily) and treatment B (participants will receive placebo once daily). Safety will be evaluated by assessment of adverse events, clinical laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram. Total study duration for each participant will be approximately 23 weeks.
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
- •Confirmed diagnosis of asthma for at least 6 months
- •Short-acting beta-agonist use greater than or equal to 5 times in the 2 weeks prior to screening
- •Healthy on the basis of physical examination, medical history, vital signs, and 12 lead ECG performed at screening
- •Having adequate laboratory values
- •No history of/active or latent tuberculosis
- •Agree to use protocol defined contraceptive methods
排除标准
- •History of life-threatening asthma attack requiring hospitalization for asthma within 5 years of screening, or emergency department treatment of asthma within the last month
- •Moderate or severe renal insufficiency
- •Cigarette smoking within the last year - Viral or bacterial vaccination within the last month (eg, FluMist)
- •Human Immunodeficiency Virus (HIV) or Hepatitis B or C positive
研究组 & 干预措施
Treatment B (Placebo)
Participants will receive matching placebo once daily for 12 weeks.
干预措施: Placebo (Drug)
Treatment A (JNJ39758979)
Participants will receive JNJ39758979 300mg once daily for 12 weeks.
干预措施: JNJ39758979 (Drug)
结局指标
主要结局
Percent change from baseline to Week 12 in pre-bronchodilator percent predicted Forced Expiratory Volume in 1 second (FEV1) value
时间窗: Baseline (Week 0) and Week 12
FEV1 will be measured by using spirometry test. Spirometry is used to measure lung function, specifically the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled. Lung volumes will be measured according to the body temperature, pressure, and saturated standard convention using the spirometer. Pre-bronchodilator spirometry will be performed in the absence of albuterol/salbutamol or at least 6 hours after the last dose of albuterol/salbutamol.
次要结局
- Percent change from baseline in post-bronchodilator percent predicted Forced Vital Capacity (FVC) value(Week 4 and Week 12)
- Percent change from baseline in pre-bronchodilator percent predicted Forced Expiratory Flow (FEF) 25-75 value(Week 1, Week 2, week 4, Week 8, and Week 12)
- Percent change from baseline in post-bronchodilator percent predicted Forced Expiratory Flow (FEF) 25-75 value(Week 4 and week 12)
- Percent change from baseline in pre-bronchodilator percent predicted Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) value(Week 1, Week 2, Week 4, Week 8, and Week 12)
- Percent change from baseline in post-bronchodilator percent predicted Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) value(Week 4 and Week 12)
- Change from baseline to Week 12 in Asthma Daily Diary (ADD) data(Week 12)
- Number of participants with worsening of asthma(From baseline (Week 0) to Week 12)
- Time to worsening of asthma(From baseline (Week 0) to Week 12)
- Percent change from baseline in pre-bronchodilator percent predicted Forced Expiratory Volume in 1 second (FEV1) value(Week 1, Week 2, Week 4, and Week 8)
- Percent change from baseline in post-bronchodilator percent predicted Forced Expiratory Volume in 1 second (FEV1) value(Week 4 and Week 12)
- Percent change from baseline in pre-bronchodilator percent predicted Forced Vital Capacity (FVC) value(Week 1, Week 2, Week 4, Week 8, and Week 12)
- Plasma concentrations of JNJ-39758979(Baseline (Week 0), Week 1, Week 2, Week 4, and Week 12)
- Serum concentrations of JNJ-39758979(Baseline (Week 0), Week 1, Week 2, Week 4, and Week 12)
- Number of participants with adverse events(From screening (Week -6) to Week 17)