A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Study to Evaluate the Efficacy and Safety of Intravenous GSK679586 in Patients With Severe Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Change From Baseline in Asthma Control Questionnaire (ACQ-7) Over 12 Weeks
研究概览
简要总结
Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study
详细描述
A Multi-Centre, Multi-country, Randomized, Double-Blind (Subject, Investigator), Placebo-Controlled, Repeat-Dose study to evaluate the Efficacy and Safety of Intravenous GSK679586 in Patients with 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of asthma for ≥ 6 months
- •taking inhaled corticosteroids
- •non-smoking
- •Baseline (pre-bronchodilator) FEV1 35-80% predicted at screening.
- •Reversible airways disease as indicated by an increase of FEV1 ≥12% from baseline after nebulised salbutamol or albuterol.
- •symptomatic according to the ACQ-7
排除标准
- •Unstable severe asthma
- •Recent respiratory illness
- •Presence of other respiratory disease or chronic pulmonary condition other than asthma
- •Treatment with omalizumab within 4 months of study
- •Recent gastrointestinal or respiratory parasitic infestation
- •History of severe allergy to food or drugs
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
GSK679586
Subjects will receive three, once monthly intravenous administration of 10 mg/kg of GSK679586, according to randomization
干预措施: INTRAVENOUS GSK679586 (Drug)
GSK679586
Subjects will receive three, once monthly intravenous administration of 10 mg/kg of GSK679586, according to randomization
干预措施: FLUTICASONE PROPIONATE (Drug)
PLACEBO
Subjects will receive three, once monthly intravenous administration of saline, according to randomization
干预措施: INTRAVENOUS PLACEBO (Drug)
PLACEBO
Subjects will receive three, once monthly intravenous administration of saline, according to randomization
干预措施: FLUTICASONE PROPIONATE (Drug)
结局指标
主要结局
Change From Baseline in Asthma Control Questionnaire (ACQ-7) Over 12 Weeks
时间窗: Baseline to Week 12
The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). The values of Week 1 is considered as Baseline. ACQ-7 was calculated as the average of the 7 scores. If any one individual score was missing, the ACQ-7 was set to missing.The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.
次要结局
- Change From Baseline in ACQ-7 Over 16 Weeks and 24 Weeks(Week 16 and Week 24)
- Number of Participants Who Demonstrated a Clinically Meaningful Change in ACQ-7 Over the 12 Weeks Assessment Period.(Upto 12 weeks)
- Change From Baseline in Forced Expiratory Volume (FEV1) Over 12 Weeks.(Baseline to Week 12)
- Change From Baseline in FEV1 Over 16 Weeks and 24 Weeks(Week 16 and 24)
- Percentage of Participants Who Demonstrated a Clinically Meaningful Increase in FEV1 Over the 12 Week Assessment Period(Upto 12 weeks)
- Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Week 25)
- Number of Participants With Clinically Significant Abnormality in 12-lead Electrocardiogram (ECG)(Upto Week 25)
- PK Parameter: Volume of Distribution(Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.)
- Number of Participants With Abnormal Clinical Chemistry Parameters of Potential Clinical Importance(Upto Week 25)
- Number of Participants With Abnormal Urinanalysis Parameters of Potential Clinical Importance(Upto Week 25)
- PK Parameter:Maximum Observed Concentration (Cmax)(Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.)
- Number of Participants With Abnormal Hematological Parameters of Potential Clinical Importance(Upto Week 25)
- Number of Participants With Confirmed Positive Anti-GSK679586 Antibody Results After Initiation of Study Treatment(Up to Week 25)
- Number of Participants With Abnormal Vital Signs of Potential Clinical Importance: Systolic and Distolic Blood Pressure and Heart Rate.(Screening, Day -28, 1, 15, 29, 50, 57 and 169 (follow-up 3))
- Pharmacokinetic (PK) Parameter: Area Under the Concentration-time Curve Over the Dosing Interval (AUC (0-τ)).(Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.)
- PK Parameter: Systemic Clearance of Parent Drug(Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.)