CTRI/2025/08/092238进行中（未招募）3 期
Efficacy and Safety of Single-Inhaler Triple Therapy (SITT) of Glycopyrronium, Formoterol Fumarate Dihydrate and Fluticasone Propionate MDI versus SITT of Budesonide Glycopyrronium and Formoterol Fumarate Dihydrate MDI in moderate-severe COPD patients: A Multi-center, Randomized, Open-label, Comparative, Parallel Group Study.
Lupin Ltd.,18 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2025年8月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 230
- 试验地点
- 18
- 主要终点
- To evaluate the efficacy of SITT of Glycopyrronium, Formoterol Fumarate and Fluticasone Propionate MDI versus SITT of Budesonide, Glycopyrronium and Formoterol Fumarate Dihydrate MDI in moderate to severe COPD patients.
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a progressive chronic disease which is subject to acute exacerbations. COPD is a multicomponent integration of chronic and progressive illnesses, characterized by airway obstruction, inflammation, hyperinflation and acute-on-chronic exacerbations. Airway obstruction in COPD is an important cause of exertional breathlessness. It slowly progresses to marked disability and respiratory failure to limit the daily activities of an individual, finally confining him to bed.
COPD is a multicomponent disease that affects the systems and organs outside the lungs. These systemic effects of COPD include weight loss, muscle dysfunction and cardiovascular disease. The subjects with COPD have a lower physical activity level even earlier in the disease process.
The Purpose of the study is to Efficacy and Safety of Single-Inhaler Triple Therapy (SITT) of Glycopyrronium, Formoterol Fumarate Dihydrate and Fluticasone Propionate MDI versus SITT of Budesonide, Glycopyrronium and Formoterol Fumarate Dihydrate MDI in moderate-severe COPD patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients, aged more than equal to 18 to less than equal to 75 years at screening Patients with a diagnosis of COPD (as defined by the GOLD COPD report 2025) Post-bronchodilator FEV1 more than equal to 30 percentage and less than 80 percentage of the predicted normal value and post-bronchodilator FEV1-FVC (forced vital capacity) ratio 0.70 A modified Medical Research Council dyspnea scale (mMRC) grade 2 COPD Assessment Test (CAT) score more than equal to 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.
- •History of exacerbations (more than equal to 2 moderate or more than equal to 1 severe exacerbation) of COPD within 12 months before screening.
- •Subjects on inhaled corticosteroid (ICS) with or without a long-acting Beta 2 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.
- •Willingness to give their written informed consent to participate in the study and willingness to comply with study requirements and procedures.
- •Female subjects with negative pregnancy tests, and agreed to use adequate forms of non hormonal contraception during the study (i.e. women of childbearing potential used a highly effective method of birth control, such as condom and spermicide, diaphragm or cervical cap and spermicide, condom and diaphragm or cervical cap, non hormonal IUD), or females who were of non child bearing potential i.e. who were surgically sterile (history of hysterectomy or bilateral tubal ligation or bilateral oophorectomy; partial hysterectomy is not sufficient or vasectomized partner) or postmenopausal (12 months of spontaneous amenorrhea), or who agreed to remain abstinent.
- •Ability to use metered dose inhaler independently and correctly as instructed by the investigator.
排除标准
- •Patient unable to perform study procedures or not willing to give informed consent
- •Patients already receiving triple drug treatment with LABA+LAMA+ICS (either in the form of SITT or MITT)
- •Patients with co-existing comorbidity such as tuberculosis, alpha-1 antitrypsin deficiency, cystic fibrosis, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease
- •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 infraction, arrhythmia, long QT syndrome, atrial fibrillation), renal, neurological, endocrine, immunological, psychiatric, hepatic, or hematological disease or abnormality which, in the opinion of the investigator, will clinically significant and have put the patient at risk through study participation, or would have affected the study analyses if the disease exacerbates during the study
- •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 was no chest X-ray/CT scan taken within six months prior to screening, a chest X-ray will be performed during screening to rule out any other significant abnormality.
- •History of paradoxical bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder neck obstruction, severe renal impairment or urinary retention, or any other condition, which, in the opinion of the investigator, would have contraindicated the use of an anticholinergic or long-acting beta agonist agent
- •History of allergy or hypersensitivity to any of the ingredients of study drugs or components of the delivery system
- •Hospitalization for COPD exacerbation or pneumonia within three months prior to screening.
- •Use of oral/parenteral corticosteroids or antibiotics for COPD exacerbation within six weeks prior to screening.
- •A clinically significant abnormal electrocardiogram (ECG) at screening.
- •Lung volume reduction surgery within 12 months prior to the initiation of the study.
- •Requirement of long-term (12 hours daily) oxygen therapy.
- •Unable to stop the following medications at the defined times prior to screening spirometry: a.
- •Ipratropium or ipratropium/salbutamol combination product-8 hours, Inhaled short-acting beta-agonists 6 hours, Oral beta2-agonists 48 hours, Long-acting beta-agonists (salmeterol and formoterol) or ICS/LABA combination products-48 hours, b.
- •Xanthines- 48 hours, Cromolyn and nedocromil inhalers 24 hours c.
- •Zafirlukast, montelukast, zileuton- 48 hours d.
- •Long-acting anticholinergics (Tiotropium etc.)-48 hours e.
- •Oral or parenteral corticosteroids- 6 weeks f.
- •Any other investigational medication 30 days or 5 half-lives of the investigational drug (whichever is longer), g.
- •Depot corticosteroids- 3 months, h.
- •Inhaled corticosteroids (ICS)- Washout not required
- •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 is longer preceding informed consent or scheduled to participate in another clinical study involving an IP.
- •Patients who are currently taking alcohol products.
结局指标
主要结局
To evaluate the efficacy of SITT of Glycopyrronium, Formoterol Fumarate and Fluticasone Propionate MDI versus SITT of Budesonide, Glycopyrronium and Formoterol Fumarate Dihydrate MDI in moderate to severe COPD patients.
时间窗: Mean change of FEV1 test from baseline to end of week 12.
次要结局
- To evaluate the safety of SITT of Glycopyrronium, Formoterol Fumarate & Fluticasone Propionate MDI versus SITT of Budesonide, Glycopyrronium & Formoterol Fumarate Dihydrate MDI in moderate to severe COPD patients.(Mean change of FEV1 test from baseline to end of week 4)
研究者
Mr Pramod Kadam
Lupin Ltd.
研究点 (18)
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