CTRI/2023/01/048668招募中3 期
A Multi-center, Randomized, Open-label, Comparative, Parallel Group study to assess the efficacy and safety of a fixed dose combination of Lupins Glycopyrronium plus Vilanterol plus Fluticasone dry powder inhaler versus fixed dose combination of Glycopyrronium plus Formoterol plus Fluticasone dry powder inhaler in patients with Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 278
- 试验地点
- 13
- 主要终点
- Change from baseline in trough FEV1
研究概览
简要总结
A Multi-center, Randomized, Open-label, Comparative,Parallel Group study to assess the efficacy and safety of a fixed dosecombination of Lupin’s Glycopyrronium + Vilanterol + Fluticasone dry powderinhaler versus fixed dose combination of Glycopyrronium + Formoterol +Fluticasone dry powder inhaler in patients with Chronic Obstructive PulmonaryDisease.
Approximately 14 weeks
Screening up to 10 days {including run-in period of atleast7 days}
Treatment period:[12 weeks]
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects meeting all the following criteria will be participating in the trial: 1.Male or female patients, aged ≥18 to ≤ 75 years at screening 2.Patients with a diagnosis of COPD (as defined by the GOLD Guidelines, 2021) 3.Post-bronchodilator FEV1 ≥30% and <80% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) ratio < 0.70 4.A modified Medical Research Council dyspnoea scale (mMRC) grade 2 or greater 5.History of exacerbations (≥2 moderate or ≥1 severe exacerbation) of COPD within 12 months before screening 6.Subjects on inhaled corticosteroid (ICS) with or without a long-acting β2 agonist (LABA) (as a free or fixed combination), or ICS with a long- acting muscarinic antagonist (LAMA), or LABA with LAMA (as a free or fixed combination), or LAMA monotherapy as maintenance treatment for at least 1 month before screening 7.Current or previous cigarette/beedi smokers with a history of cigarette/beedi smoking of at least 10 pack/years.
- •(Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Screening Visit).
排除标准
- •1.Patients who are currently receiving triple drug treatment with LABA+LAMA+ICS 2.Known respiratory disorders other than COPD including, but not limited to the following: asthma, tuberculosis, alpha-1 antitrypsin deficiency, cystic fibrosis, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease.
- •3.Evidence or history of other clinically significant cardiovascular disease or abnormality (such as, but not limited to, congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, arrhythmia, long QT syndrome, atrial fibrillation), renal, neurological, endocrine, immunological, psychiatric, hepatic, or hematological disease or abnormality which, in the opinion of the investigator, are clinically significant and would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbates during the study 4.Significant abnormality that suggests chest disease other than COPD, on chest X-ray or computed tomography (CT) scan taken within six months before screening.
- •If there is no chest X-ray/CT scan is taken within six months prior to screening, a chest X-ray will be performed during screening to rule out any other significant abnormality 5.History of paradoxical bronchospasm, uncontrolled narrow-angle glaucoma, prostatic hyperplasia, bladder neck obstruction, or severe renal impairment or urinary retention or any other condition, which, in the opinion of the investigator, would contraindicate the use of an anticholinergic or long-acting beta-agonist agent 6.History of allergy or hypersensitivity to any of the ingredients of study drugs or components of the delivery system 7.Suspected or confirmed SARS-COV2 infection at screening (prior to randomization the subjects will be tested for COVID 19 through rapid antigen test).
- •8.Hospitalization for COPD exacerbation or pneumonia within three months prior to screening.
- •Any subject who experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in period will be excluded 9.Use of oral/parenteral corticosteroids or antibiotics for COPD exacerbation within six weeks prior to screening 10.Clinically significant abnormal electrocardiogram (ECG) finding at screening 11.Lung volume reduction surgery within 12 months prior to the initiation of the study 12.Requirement of long term (> 12 hours daily) oxygen therapy 13.Unable to stop the following medications at the defined times prior to screening spirometry: Medication Required washout period prior to screening spirometry Ipratropium or 8 Hrs ipratropium/salbutamol combination product Inhaled short acting β-agonists 6 hours Oral β 2-agonists 48 hours Long acting β-agonists (salmeterol and formoterol) or ICS/LABA combination products 48 hours Xanthines 48 hours Cromolyn and nedocromil inhalers 24 hours Zafirlukast, montelukast, zileuton 48 hours Long-acting anticholinergics (Tiotropium etc.) 48 hours Oral or parenteral corticosteroids 6 weeks Any other investigational medication 30 days or 5 half-lives of the investigational drug (whichever is longer) Depot corticosteroids 3 months Inhaled corticosteroids (ICS) Washout not required 15.Currently enrolled in another interventional clinical study or have used any IPs, study drug, or device within 30 days or 5 times the half-life, whichever was longer preceding informed consent or scheduled to participate in another clinical study involving an IP.
- •Additional exclusion criteria for Run-In period: COPD exacerbation requiring treatment with antibiotics, systemic corticosteroids (oral or intravenous), and/or a hospitalization during screening and run-in period.
结局指标
主要结局
Change from baseline in trough FEV1
时间窗: 12 weeks
次要结局
- 1. Change from baseline in Trough FEV1(2.Change from baseline in 2 h post-dose FEV1)
研究者
研究点 (13)
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