A Multi-center, Randomized, Double-blind, Placebo and Active-controlled Study With Exploratory Dose-ranging to Investigate the Efficacy and Safety of 16 Weeks Treatment With Subcutaneous (s.c.) QGE031 in Asthma Patients Not Adequately Controlled With High-dose Inhaled Corticosteroids and Long Acting β2-agonists
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 471
- 试验地点
- 1
- 主要终点
- Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo
研究概览
简要总结
This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.
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
- Double (Participant, Investigator)
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
- •A diagnosis of allergic asthma , uncontrolled on current medication.
- •History of at least 1 asthma exacerbation during the last 1 year
- •Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted normal value; reversibility following administration of bronchodilator must also be demonstrated (historical positive reversibility or bronchoprovocation result can be used).
排除标准
- •Baseline IgE levels or body weight outside the omalizumab dosing table.
- •Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
- •Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.
研究组 & 干预措施
QGE031 240 mg q4w
Participants received QGE031 240 mg s.c. q4w for 16 weeks.
干预措施: QGE031 (Drug)
QGE031 240 mg every 2 weeks (q2w)
Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks.
干预措施: QGE031 (Drug)
QGE031 180 mg q2w
Participants received QGE031 180 mg s.c. q2w for 16 weeks.
干预措施: QGE031 (Drug)
QGE031 120 mg q2w
Participants received QGE031 120 mg s.c. q2w for 16 weeks.
干预措施: QGE031 (Drug)
QGE031 36 mg q2w
Participants received QGE031 36 mg s.c. q2w for 16 weeks.
干预措施: QGE031 (Drug)
QGE031 12 mg q2w
Participants received QGE031 12 mg s.c. q2w for 16 weeks.
干预措施: QGE031 (Drug)
Omalizumab (as per locally approved dosing table)
Participants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks.
干预措施: Omalizumab (Drug)
Placebo to QGE031 240 mg q2w
Participants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks.
干预措施: Placebo (Drug)
Placebo to QGE031 240 mg q4w
Participants received placebo to QGE031 240 mg s.c. q2w for 16 weeks.
干预措施: Placebo (Drug)
Placebo to QGE031 180 mg q2w
Participants received QGE031 180 mg s.c. q2w for 16 weeks.
干预措施: Placebo (Drug)
Placebo to QGE031 120 mg q2w
Participants received QGE031 120 mg s.c. q2w for 16 weeks.
干预措施: Placebo (Drug)
Placebo to QGE031 36 mg q2w
Participants received QGE031 36 mg s.c. q2w for 16 weeks.
干预措施: Placebo (Drug)
Placebo to QGE031 12 mg q2w
Participants received QGE031 12 mg s.c. q2w for 16 weeks.
干预措施: Placebo (Drug)
Placebo to omalizumab
Participants received placebo to omalizumab s.c. q2w or q4w for 16 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo
时间窗: Week 16
The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - \> 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - \< 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.
次要结局
- Change From Baseline in ACQ-7 Score(Baseline, Weeks 4, 8, 12, 16 and 28)
- Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1(Week 16)
- Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score(Baseline, Week 16, Week 28)
- Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication(Baseline, Week 16)