NCT01479595已完成2 期
A Randomized Double-blind Multiple-dose Placebo-controlled Trial to Establish the Efficacy of QBX258 (Combination of VAK694 and QAX576) in Asthma That is Inadequately Controlled With Inhaled Corticosteroids and Long Acting Beta Agonists
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
- 65
- 试验地点
- 1
- 主要终点
- Change From Baseline in Asthma Control Questionnaire (ACQ) Score
研究概览
简要总结
This study is designed to investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma.
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
- •Patients with atopic asthma >1 year duration diagnosed according to the GINA guidelines.
- •Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 39 kg/m
- •Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of > 1.
- •FEV1 40 to 90% of predicted.
排除标准
- •Diagnosed with COPD as defined by the GOLD guidelines
- •Subjects who have had a respiratory tract infection within 4 weeks prior to screening.
- •Women of child-bearing potential must use highly effective methods of contraception during dosing and for at least 18 weeks after last study drug administration
研究组 & 干预措施
QBX258
Experimental
Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
干预措施: QBX258 (Drug)
Placebo
Placebo Comparator
Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Asthma Control Questionnaire (ACQ) Score
时间窗: Baseline and 12 weeks
The ACQ consists of 7 questions assessing symptoms, rescue medication use and lung function. Except for lung function (FEV1), each question was scored on a 7-point scale where 0 = no impairment and 6 = maximum impairment. Scores ranged between 0 totally controlled to 6 (severely uncontrolled). Participants with a score below 1.0 are considered to have adequately controlled asthma. Participants with a score above 1.0 were considered not to be well controlled. A negative change from baseline indicates improvement.
次要结局
- Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the QAX576 Analyte(days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183)
- Change in Forced Expiratory Volume in One Second (FEV1)(Baseline and 12 weeks)
- Change in Asthma Quality of Life Questionnaire (AQLQ) Score(Baseline and 12 weeks)
- Morning and Evening Peak Expiratory Flow (PEF) Rate(Baseline and 12 weeks)
- Change From Baseline in Maximum Expiratory Flow(Baseline and 12 weeks)
- Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies(12 weeks)
- Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the VAK694 Analyte(days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183)
- Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the QAX576 Analyte(days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183)
- Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the VAK694 Analyte(days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183)
- Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)(baseline, 12 weeks)
研究者
研究点 (1)
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