EVITA Trial: Effect of VItamin D as add-on Therapy for vitamin D insufficient patients with severe Asthma: a randomized, double-blind, placebo-controlled trial. - EVITA

niversity Medical Center of the Johannes Gutenberg University Mainz0 个研究点目标入组 160 人开始时间: 2014年11月4日最近更新: 2018年4月30日

适应症

试验速览

暂无简介。

•Subjects meeting all of the following criteria will be considered for enrolment into the trial:
•- Male or female, age = 18 years with a pulmonary specialist diagnosis of severe asthma according to the Global Initiative for Asthma (GINA 2014, www.ginasthma.org) and the German Asthma Net (GAN, www. German-asthmanet.de)
•- Treatment with long-acting ß2-agonists (LABA) and inhaled corticosteroids (ICS) at a dose of at least 1000 µg beclomethasone (or equivalent) per day, chronic oral corticosteroid (OCS) use is allowed
•- Asthma Control Questionnaire (ACQ-5) score = 1.5
•- Vitamin D insufficiency as defined by a serum vitamin D concentration of <30 ng/ml but = 10 ng/ml at screening
•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 140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Subjects presenting one of the following criteria will not be enrolled in the trial:
•- Patients on vitamin D substitution
•- Impaired renal function (GFR < 30 ml/min) and history of physician-diagnosed nephrolithiasis
•- Within the past 4 weeks respiratory tract infection or asthma exacerbation requiring systemic corticosteroids or increase in systemic corticosteroids
•- Chronic respiratory diseases (other than asthma)
•- Current smokers or ex-smokers with a smoking history of more than 10 packyears

发起方

niversity Medical Center of the Johannes Gutenberg University Mainz