CTRI/2019/01/017156已完成3 期
A randomized, double-blind, clinical trial to assess the efficacy and safety of fixed dose combination Dry Powder Inhaler of Glycopyrronium 12.5 μg/Formoterol Fumarate 12 μg/Fluticasone Propionate 250 μg in comparison with fixed dose dry powder inhaler Glycopyrronium 50 μg co-administered with fixed dose dry powder inhaler combination of Formoterol Fumarate 12 μg/Fluticasone Propionate 250 μg in patients with chronic obstructive pulmonary disease
Glenmark Pharmaceuticals Ltd0 个研究点目标入组 396 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 396
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female, aged >=40 to <=75 years at the time of informed consent
- •2. Current or previous cigarette/beedi smokers with a history of cigarette or beedi smoking of at least 10 pack-years [e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
- •3. Diagnosis of COPD (as defined by the GOLD Guidelines, 2017)
- •4. Post-bronchodilator FEV1/ FVC < 0.70 and post-bronchodilator FEV1>=30% predicted and <80% predicted, at screening visit.
- •5. History of at least two exacerbations of COPD within 12 months before screening.
- •6. A modified Medical Research Council dyspnoea (mMRC) grade 2 or greater.
- •7. Patients using inhaled corticosteroid (ICS) with or without a long-acting β2 agonist (LABA) (as a free or fixed combination), or ICS with 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.
- •8. No significant abnormality suggesting chest disease other than COPD
排除标准
- •1. A current or historic diagnosis of asthma.
- •2. Treatment with long-acting muscarinic agonist (LAMA), long-acting beta-agonist (LABA) and inhaled corticosteroids (ICS) in one or multiple inhalers, within 1 month before screening.
- •3. History of narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate-to-severe renal impairment or urinary retention (Subjects with a transurethral resection of prostate, subjects who have undergone full re-section of the prostate and, subjects who are asymptomatic and stable on pharmacological treatment for the condition will be considered for the study). Patients with post-void residue of >50 mL on ultrasonography at screening will be excluded from the study. Patients with an intra-ocular pressure of >21 mm of Hg in any eye, at screening will be excluded from the study.
- •4. Hospitalization for COPD exacerbation or pneumonia within 3 months prior to Visit 1.
- •5. Known respiratory disorders other than COPD including but not limited to alpha-1 antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, history of allergic rhinitis or atopy, pulmonary hypertension, and interstitial lung disease.
- •6. Any previous lung resection surgery (e.g., lung volume reduction surgery or lobectomy).
- •7. Type I or uncontrolled Type II diabetes
- •8. Chest X-ray or CT scan, which reveals evidence of clinically significant abnormalities, not believed to be due to the presence of COPD (e.g., evidence of pneumonia, other infection, atelectasis, or pneumothorax).
- •Use of oral/depot corticosteroids or antibiotics for COPD exacerbation within 6 weeks prior to Visit 1 or subject has had a change in dose or type of any medications for COPD within 1 month before Visit 1.
研究者
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