An open label single arm, multicentric, prospective, phase IV study to evaluate the safety and effectiveness of Indacaterol/ Mometasone/ Glycopyrronium DPI in the management of Asthma patients
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 182
- 试验地点
- 5
- 主要终点
- Number of patients with serious TEAEs (STEAEs)
研究概览
简要总结
The study is a prospective, open label, multicentre, single arm, interventional, phase IV study to evaluate the safety and effectiveness of IND/MF/GLY DPI in the management of Asthma among Indian patients. Adult patient with uncontrolled Asthma will be enrolled in the study. Clinical diagnosis of Asthma will be as per the standard definition by GINA 2022. A detailed medical history will be obtained and also physical examination will be conducted for each patient by the study investigators. Treatment duration is 12 weeks and patients will be followed-up till the end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •a.Patients ≥18 years of age with a documented physician diagnosis of Asthma b.
- •ACQ-5 score ≥ 1.5 at baseline.
- •History of one or more asthma exacerbations in last one year.
- •Ability to use dry powder inhaler independently and correctly in view of the investigator.
- •Patient is willing to sign a written informed consent form and agree to follow up on a regular basis as specified in the protocol.
排除标准
- •History of current hospitalization with life threatening condition or patients with acute exacerbation of asthma (acute condition).
- •Smoking history of more than 10 pack-years.
- •Ongoing treatment with Triple therapy i.e. ICS/LABA/LAMA.
- •Subjects with any life threatening condition.
- •Women of childbearing potential are not restricted in this study, however it is expected that the investigator will assess the risks and benefits of the assigned treatment as per the product label(s) and discuss this with any women of childbearing potential prior to providing the patient with the prescription for the assigned treatment.
- •Subjects with history of hypersensitivity to the active substance or to any of its excipients of study drug.
结局指标
主要结局
Number of patients with serious TEAEs (STEAEs)
时间窗: At week 12
To evaluate the safety of IND/MF/GLY DPI in treatment of Asthma in Indian population
时间窗: At week 12
Number of patients with any drug related treatment emergent adverse events (TEAEs).
时间窗: At week 12
Number of patients with TEAEs
时间窗: At week 12
次要结局
- To evaluate the effectiveness of IND/MF/GLY DPI in treatment of Asthma in Indian population(Mean change in Trough FEV1 from baseline)