A Multicenter, Prospective, Open Label, Single arm, Phase IV Study to Assess the Safety and Effectiveness of Vilfuro-G Fixed Dose Combination (Fluticasone Furoate 100 mcg and Glycopyrronium Bromide Ph. Eur. eq. to Glycopyrronium 50 mcg and Vilanterol Trifenatate eq. to Vilanterol 25 mcg) Inhalation powder in Capsule for maintenance treatment of Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease
概览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Dr Lokesh Kumar General Manager
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Patients with Adverse Events (AEs)
概览
简要总结
COPD is a common preventable, and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation due to abnormalities in the airway and (or) alveolar abnormalities.
It is the leading cause of disability among chronic respiratory diseases and was the second leading contributor of Disability Adjusted Life Years (DALY) in 2016. In 2016, nearly 32% of global DALYs due to COPD occurred in India and COPD is responsible for 75.6% of total DALYs among chronic respiratory disease in India.
The Purpose of the Study is To evaluate the safety & Effectiveness of FDC for maintenance treatment of Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
研究设计
- 研究类型
- Pms
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females aged 18 years and above.
- •Diagnosed with moderate to severe COPD as per the Global Initiative for Obstructive Lung Disease (GOLD) 2023 guidelines classification.
- •COPD Assessment Test (CAT) score ≥ 10 even after receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) for at least 4-6 weeks at the time of screening.
- •Willing to take the medications as directed.
- •Willing to comply with the protocol requirements.
- •Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures.
- •Post-menopausal female patients, or female of child bearing age must agree to use highly effective contraceptive measures with her partner during the study and for 90 days following their last dose.
排除标准
- •Known hypersensitivity to Fluticasone, Glycopyrronium, Vilanterol, other beta-2 agonists, other anti-muscarinic agents, other corticosteroids or excipients of formulation.
- •Known α1-antitrypsin deficiency.
- •Known history of HIV or HBV or HCV infection.
- •COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period.
- •Hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period.
- •Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period.
- •Known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention.
- •Clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy.
- •Known history of hepatic dysfunction.
- •With continuing history of alcohol and/or drug abuse.
结局指标
主要结局
Patients with Adverse Events (AEs)
时间窗: Entire duration of Study and at Week 6 and a Week 12 (EOS)
Incidence rate of AEs (Serious/non-serious, Expected/Non- expected, Related/ Non-related)
时间窗: Entire duration of Study and at Week 6 and a Week 12 (EOS)
Safety of patient will be monitored throughout the study
时间窗: Entire duration of Study and at Week 6 and a Week 12 (EOS)
次要结局
- Mean change in COPD Assessment Test (CAT) score at week 12 from baseline.(Proportion of patients with improvement in modified Medical Research Council (mMRC) score at end of week 12.)
研究者
Jamnadas Kushwaha
Raptim Research Pvt. Ltd.