An Open Label, Single Arm, Multicentric, Prospective, Phase IV Study to Evaluate the safety and efficacy of FDC Glycopyrronium, Fluticosone Furoate and Vilanterol DPI in Management of COPD Patients in India (ADHERENT STUDY)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 187
- 试验地点
- 6
- 主要终点
- To evaluate the safety of VILOR® FG 100 DPI in treatment of moderate to severe COPD in Indian population.
研究概览
简要总结
The study is a prospective open label multicentre single arm interventional study to evaluate the safety and efficacy of VILOR® FG 100 DPI in the management of COPD among Indian patients. Clinical diagnosis of COPD will be as per the standard definition by American Thoracic Society or European Respiratory Society or GOLD 2024. The study would be initiated at each site after review and approval from ethics committee. At screening & baseline the potential patients both male and female more than or equal to 40 years of age with COPD will be screened and enrolled in the study and a written informed consent would be procured before any study related procedures are undertaken. The clinical assessment as per schedule of assessments would be performed throughout the study and Patient will be followed up till end of the study. Treatment and study duration will be 12 weeks.
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
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients aged more than or equal to 40 years with diagnosis of COPD as defined by the GOLD Guidelines 2024 Global Initiative for Chronic Obstructive Lung Disease GOLD 2024 2 Post bronchodilator FEV1/FVC less than 0.70 and post-bronchodilator FEV1 more than or equal to 30 percent predicted and less than 80 percent predicted 3 Symptomatic patients receiving ongoing maintenance therapy ICS/LABA or LAMA or LABA/LAMA 4 Patients with exacerbation history in past 1 year.
- •5 Ability to use DPI independently and correctly in view of the investigator 6 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
- •1 Documented current diagnosis of asthma 2 Ongoing treatment with Triple therapy (i.e. ICS/LABA/LAMA) 3 Subjects with any life threatening condition or requiring hospitalization for management of current condition 4 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 5 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
To evaluate the safety of VILOR® FG 100 DPI in treatment of moderate to severe COPD in Indian population.
时间窗: 12 Weeks
Co-Primary: To evaluate the efficacy of VILOR® FG 100 DPI, in terms of lung function improvement in treatment of moderate to severe COPD in Indian population.
时间窗: 12 Weeks
次要结局
- To evaluate the efficacy of VILOR® FG 100 DPI, in terms of patient satisfaction and outcome in treatment of moderate to severe COPD in Indian population.(12 Weeks)