A Randomised Double-blind, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of VR506 From a New Dry Powder Inhaler in Subjects With Severe Persistent Asthma Requiring Oral Corticosteroid Therapy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 77
- 主要终点
- Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)
研究概览
简要总结
To evaluate the clinical efficacy, safety, tolerability and dose-response relationship, using oral corticosteroid (OCS) modulation, of 3 different doses of VR506 using a twice daily regimen from a new dry powder inhaler (nDPI) for 16 weeks in subjects with severe persistent asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative for Asthma (GINA) guidelines 2011.
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose 1 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
干预措施: VR506 (Drug)
Dose 2 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
干预措施: VR506 (Drug)
Dose 3 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
干预措施: VR506 (Drug)
结局指标
主要结局
Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)
时间窗: 16 weeks
The mean asthma control prednisone/prednisolone dose at end of study (week 16)
次要结局
- Number of Participants With Withdrawals Due to Worsening of Asthma(16 weeks)
- Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Asthma Control Questionnaire (ACQ-5) Mean Total Score(Baseline and 16 weeks)
- Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)(Baseline and 16 weeks)
- Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)(Baseline and 16 weeks)
- Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Weekly Average Asthma Night-time Symptom Score(Baseline and 16 weeks)
- Assessment of Acceptability of the Device(16 weeks)