Effects of ROFLUMILAST on markers of subclinical atherosclerosis In stable COPD; the ELASTIC-trial - the ELASITC-trial

udwig Boltzmann institute for COPD and Respiratory Epidemiology0 个研究点目标入组 80 人开始时间: 2012年2月17日最近更新: 2016年5月30日

适应症

试验速览

暂无简介。

•Over 40 years of age
•Smoking history of at least 10 pack years
•Chronic obstructive pulmonary disease at GOLD-stage II - IV
•History of at least one COPD exacerbation requiring systemic corticosteroid treatment or hospitalisation in the previous year
•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 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•Insufficient compliance to study medication (=70% of tablets used) during 4 weeks run-in period
•History of acute exacerbation 4 weeks prior to run-in period
•Diagnosis of alpha-1-antitrypsine deficiency
•Diagnosis of asthma
•Acute respiratory infections (e.g. pneumonia)
•Severe acute infectious diseases (e.g. active hepatitis, HIV)
•Lung cancer
•Bronchiectasis
•Interstitial lung disease
•Any other relevant lung disease
•Acute myocardial infarction
•Systolic left ventricular dysfunction
•Congestive heart failure NYHA (New York Heart Association Functional Classification) severity grade IV)
•Haemodynamically significant cardiac arrhythmias or heart valve deformations
•Peripheral arterial occlusive disease
•Acute or chronic renal/hepatic failure
•Active malignancy
•Autoimmune disease
•Pregnant or breastfeeding women
•Women no using or not willing to use adequate contraceptive measures for the duration of the trial
•Hypersensitivity to study medication or placebo
•Severe psychiatric or neurological disorders or history of depression associated with suicidal ideation or behaviour
•Galactose intolerance, lactase insufficiency or glucose-galactose malabsorption

发起方

udwig Boltzmann institute for COPD and Respiratory Epidemiology