Does simvastatin treatment affect COPD exacerbations? - Evaluation in a randomized controlled trial - Simvastatin and COPD exacerbation

Abteilung für Pulmologie, Landesklinikum Thermenregion Hochegg0 个研究点目标入组 208 人开始时间: 2012年7月9日最近更新: 2020年10月13日

适应症

试验速览

暂无简介。

•male or postmenopausal (amenorrhoe > 12 month) female patients with an age of 40 to 85 years
•diagnosed COPD im stage II-IV according to GOLD
•smoker or prior smoker with at least 20 pack years
•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 104
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 104

•diagnosed lung diseases except from COPD, bronchiectasis and chronic asthmatic bronchitis
•known vascular diseases like instable angina pectoris, prior myocardial infarction, stroke or peripheral artery disease
•known heart valve disease, relevant arrhythmia, conduction disorder or cardiac insufficiancy
•severe hypertension despite medical treatment
•treatment with CYP3A4 inhibitors (e.g. itraconazol, ketoconazol, HIV- protease inhiitors, erythromycin, clarithromycin, telithromycin and nefazodon)
•severe liver disorder
•chronic kidney disease (kreatinin-clearance < 30ml/min)
•allergy to simvastatin
•known myopathy or other diseases with an increased risk of rhabdomyolysis
•galaktose intolerance, Lapp lactase deficiency or glucose galactose malabsorption
•statin therapy within the last 4 weeks pror to study enrollment
•disability to give written consent

发起方

Abteilung für Pulmologie, Landesklinikum Thermenregion Hochegg