CTRI/2023/12/060605进行中（未招募）4 期
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 - OASIS Study
Glenmark Pharmaceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •a.Patients =18 years of age with a documented physician diagnosis of Asthma
- •b. Symptomatic patients on ongoing maintenance therapy with ICS/LABA or ICS/FOR
- •c. ACQ-5 score = 1.5 at baseline.
- •d. History of one or more asthma exacerbations in last one year.
- •e. Ability to use dry powder inhaler independently and correctly in view of the investigator.
- •f. 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
- •a. History of current hospitalization with life threatening condition or patients with acute exacerbation of asthma (acute condition).
- •b. Smoking history of more than 10 pack-years.
- •c. Ongoing treatment with Triple therapy i.e. ICS/LABA/LAMA.
- •d. Subjects with any life threatening condition.
- •e. 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.
- •f. Subjects with history of hypersensitivity to the active substance or to any of its excipients of study drug.
研究者
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