EUCTR2013-001445-13-DE进行中（未招募）1 期
A randomized, double-blind, multicenter, 2-period single-dose cross-over study to assess the early bronchodilation of Glycopyrronium bromide (44 µg o.d.) compared to Tiotropium (18 µg. o.d.) in patients with moderate to severe COPD - FAST
ovartis Pharma GmbH0 个研究点目标入组 152 人开始时间: 2013年5月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 152
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
- •2.Patients with moderate to severe COPD defined by a post-bronchodilator FEV1/FVC ratio of <0.70 and a post-bronchodilator FEV1 of =70% and FEV1 = 30% of predicted normal values.
- •3.Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •o History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
- •o History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
- •o Patients, who have already been randomized into this trial earlier must not be included a second time.
- •o Study personnel or first degree relatives of investigator(s) must not be included in the study.
- •o Patients incapable of giving full informed consent.
- •o who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml))
- •o who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (Pearl Index <1) during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (serum) for all women is required with sufficient lead time before inclusion
- •COPD specific exclusion criteria
- •1.Patients with Type I or uncontrolled Type II diabetes (HbA1C > 8%).
- •2.Patients with a history of long QT syndrome or whose QTc calculated at run-in (Bazett formula) is prolonged (>450 ms). These patients should not be re-enrolled.
- •3.Patients who have a clinically significant ECG abnormality at run-in.
- •4.Patients who have a clinically significant laboratory abnormality at run-in.
- •5.Patients with a body mass index (BMI) of more than 40 kg/m2.
- •6.Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or haemotological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment.
- •7.Patients with paroxysmal (e.g., intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blockers, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at the run-in (Visit 2) with a resting ventricular rate < 100/min.
- •8.Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof:
- •a.Muscarinic antagonist agents
- •b.long and short acting beta-2 agonists
- •c.sympathomimetic amines
- •d.lactose or any of the other excipients of the trial medication
- •9.Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment (GFR <50 ml/min/1,732) or urinary retention. (BPH patients who are stable on treatment can be considered).
- •10.Patients who have not achieved acceptable spirometry results at run-in in accordance with ATS/ERS criteria for acceptability and repeatability.
- •11.Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening.
- •12.Patients who develop a COPD exacerba
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