CTRI/2020/05/025323尚未招募3 期
A 12-week treatment, multi-centre, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy, safety, and tolerability of a fixed dose combination of nebulized Glycopyrronium 25mcg/ Arformoterol 15mcg solution for inhalation in comparison with Glycopyrronium 25mcg inhalation solution in subjects with chronic obstructive pulmonary disease.
Glenmark Pharmaceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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
- •Male or female, aged >40 (40 years completed) to <=75 years at the time of informed consent.
- •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.
- •Patients with a diagnosis of COPD for a period of at least 6 months prior to screening visit
- •Patients receiving stable treatment for COPD for at least 1 month before screening, i.e. no change in the dose, dosing regimen, medication and other interventions for COPD for at least 1 month before screening.
- •Patients currently not receiving a fixed or free combination of long-acting muscarinic antagonist (LAMA) and long-acting beta-2 agonist (LABA), with or without inhaled corticosteroid.
- •Post-bronchodilator FEV1 >=30% and <80% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) ratio < 0.70
- •A modified Medical Research Council dyspnoea scale (mMRC) grade 2 or greater.
- •Provide written informed consent
- •Female subjects must have a negative pregnancy test at Screening Visit , and agree to use an adequate forms of non-hormonal contraception during the study (i.e., women of child bearing potential must use 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 are of non-child bearing potential i.e., who are 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 agree to remain abstinent.
- •Male subjects must agree to either remain abstinent or use a highly effective method of birth control as described above.
- •Willing and able to comply with all aspects of the protocol.
- •Ability to use the inhalation devices independently & correctly.
排除标准
- •History or current diagnosis of asthma
- •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, pulmonary hypertension, and interstitial lung disease.
- •Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation (including the mild COPD exacerbation) within 6 weeks prior to screening or during the run-in period
- •Hospitalization for COPD exacerbation or pneumonia within 3 months prior to Screening Visit.
- •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)..
- •Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy (Subjects with a transurethral resection of prostate, subjects who have undergone full re-section of the prostate will be considered for the study, as well as subjects who are asymptomatic and stable on pharmacological treatment for the condition).
- •Use of oral/depot corticosteroids or antibiotics for COPD within 6 weeks prior to Screening Visit or subject has had a change in dose or type of any medications for COPD within 1 month before the Screening Visit.
- •Has a clinically relevant laboratory abnormality or a clinically significant condition, in the judgment of the investigator, such as (but not limited to):
- •Unstable ischemic heart disease, left ventricular failure (New York Heart Association Class III and IV), history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation). Subjects with such events not considered clinically significant by the investigator will be considered for inclusion in the study
- •Uncontrolled hypo- or hyperthyroidism, hypokalaemia or hyperadrenergic state or any condition, which might compromise subject safety or compliance, interfere with evaluation, or preclude completion of the study.
- •An abnormal and clinically significant 12-lead electrocardiogram (ECG) as per investigatorâ??s discretion. For the purposes of this study, an abnormal ECG will be defined as a 12-lead tracing which is interpreted with (but not limited to) any of the following:
- •Clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-White syndrome)
- •Myocardial ischemia
- •Clinically significant arrhythmias (e.g., atrial fibrillation, ventricular tachycardia)
- •A QTcF value at screening >=450 msec (for males) / >=470 msec (for females)
- •Patients with abnormal liver function tests defined as Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), or total bilirubin >= 2.5 times upper limit of normal ranges at screening
- •Pregnant or lactating women.
研究者
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