CTRI/2025/12/098826招募中4 期
A prospective, open label, single-arm, multicentre, phase IV clinical trial to assess efficacy and safety of Vilanterol, Glycopyrronium and Fluticasone furoate powder for Inhalation in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 234
- 试验地点
- 13
- 主要终点
- Change from baseline in trough FEV1 at the end of the study
研究概览
简要总结
In this study, the efficacy and safety of FDC of Vilanterol, Glycopyrronium and Fluticasone furoate Inhalation (DPI) 25 mcg, 50 mcg and 100 mcg (Test drug) will be evaluated in patients with moderate to severe COPD. The drug in form of capsule to be inhaled once daily. All the enrolled patients will be instructed to take the test drug for the treatment period of 12 weeks. In this study, the patients with moderate to severe COPD receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) will be screened (visit 1) within 7 days prior to their enrolment. The eligible patients will then be enrolled to test drug on baseline visit (visit 2, day 0). After enrolment, patients will then be followed up on an outpatient basis with scheduled visits at week 4 (visit 3), week 8 (visit 4) and week 12 (visit 5).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender between 40-65 years of age (both inclusive)
- •Patients who are current or ex-smokers
- •Patients diagnosed with moderate to severe COPD as per the GOLD guidelines classification at screening visit: a.
- •Post-bronchodilator FEV1/FVC ratio less than 0.7; b.
- •Post-bronchodilator FEV1, more than or equal to 30% to less than 80% predicted
- •Clinically stable COPD (patient shall be taking at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) within 4 weeks prior to the screening visit and during the screening period
- •COPD Assessment Test (CAT) score more than or equal to 10 at screening
- •Patients willing to provide written informed consent and comply with the protocol requirements 7.
排除标准
- •Patients suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc.
- •Patients with known hypersensitivity to vilanterol, glycopyrronium, fluticasone, salbutamol, other beta-2 agonists or other anti-muscarinic agents
- •Patients diagnosed with COVID-19 within 3 months prior to screening
- •Patients with known alpha1 antitrypsin deficiency
- •COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period
- •Patients 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
- •Patients who required long-term oxygen therapy (more than equal to 12 hours/day) within 4 weeks prior to the screening or during the screening period
- •Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention
- •Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy
- •Patients with hepatic dysfunction (serum transaminases more than equal to 3 times of Upper Normal Limit) or renal dysfunction (serum creatinine more than equal to 2.5 mg/dl) at screening
- •Patients who have used prohibited medications
- •Patients with continuing history of alcohol and/or drug abuse
- •Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
- •Any other reason for which the investigator feels that the patient should not participate.
结局指标
主要结局
Change from baseline in trough FEV1 at the end of the study
时间窗: At 12 weeks
次要结局
- Efficacy:(Change from baseline in trough FEV1 at week 4)
研究者
Dr Deven V Parmar
Zydus Healthcare Ltd.
研究点 (13)
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