EUCTR2016-003989-12-NL进行中（未招募）1 期
THE EFFECT OF TWICE DAILY ACLIDINIUM BROMIDE/FORMOTEROL FUMARATE 340/12 MCG VS ONCE DAILY TIOTROPIUM RESPIMAT 5MCG ON STATIC AND DYNAMIC HYPERINFLATION IN PATIENTS WITH COPD DURING 24 HOURS - BOTH
CIRO, center of expertise in chronic organ failure0 个研究点开始时间: 2017年5月10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
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 and female adults (with an equal sex ratio not exceeding 35-65%) aged >40 years with written informed consent obtained prior to any study-related procedure.
- •2.Patients entering pulmonary rehabilitation at CIRO.
- •3.Patients with a diagnosis of moderate to very severe COPD at least 12 months before the screening visit (A post-bronchodilator FEV1 <80% of the predicted normal value and a post-bronchodilator FEV1/FVC <0.7 at least 10-15 min after 4 puffs (4 x 100 mcg) of salbutamol)
- •4.Patients with severe static hyperinflation defined as residual volume (body box) >150 % predicted.
- •5.Current smokers or ex-smokers with a smoking history of at least 10 pack years [pack-years = (number of cigarettes per day x number of years)/20].
- •6.MMRC score >2.
- •7.A cooperative attitude and ability to use correctly the inhalers.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 29
排除标准
- •1. Pregnant or lactating women
- •2.Patients requiring use of the following medications:
- •a. A course of systemic steroids longer than 3 days for COPD exacerbation in the 4 weeks prior to screening.
- •b. A course of antibiotics for COPD exacerbation longer than 7 days in the 4 weeks prior to screening. NB; maintenance treatment of macrolides is allowed, without any changes in the regimen in the 4 weeks prior to the study.
- •c. PDE4 inhibitors in the 4 weeks prior to screening.
- •d. Xanthines in the 4 weeks prior to screening.
- •e. Use of antibiotics for a lower respiratory tract infection (e.g pneumonia) in the 4 weeks prior to screening.
- •3.COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period.
- •4.Patients treated with non-cardio selective B-blockers in the month preceding the screening visit or during the run-in period.
- •5.Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study, or if taken as PRN.
- •6.Patients requiring long term oxygen therapy for chronic hypoxemia.
- •7.Known respiratory disorders other than COPD which may impact the efficacy of the study drug according the investigator's judgment.
- •8.Previous lung surgery or endoscopic lung volume reduction interventions.
- •9.Patients who have clinically significant cardiovascular condition
- •10.Patients with atrial fibrillation (AF):
- •11.An abnormal and clinically significant 12-lead ECG which may impact the safety of the patient according to investigator's judgement. Patients whose electrocardiogram (ECG12 lead) shows QTcF>450 ms for males or QTcF>470 ms for females at screening visit are not eligible (not applicable for patient with pacemaker).
- •12.Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic agents.
- •13.History of hypersensitivity to anticholinergics, B2-agonist or any of the excipients contained in any of the formulations used in the trial which may raise contra-indications or impact the efficacy of the study drug according to the investigator's judgement.
- •14.Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study drug according to investigator's judgement.
- •15.Patients with hypokalaemia (serum potassium levels >3.5 mEq/L (or 3.5 mmol/L)) or uncontrolled hyperkalaemia according to investigator's judgment.
- •16.Unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; uncontrolled gastrointestinal disease (e.g. active peptic ulcer); uncontrolled neurological disease; uncontrolled haematological disease; uncontrolled autoimmune disorders, or other which may impact the efficacy or the safety of the study drug according to investigator's judgment.
- •17.Patients with any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next six months (after V1) or with malignancy for which they are currently undergoing radiation therapy or chemotherapy.
- •18.History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit.
- •19.Participation in anoth
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