Effect of Azithromycin on Lipoproteins and Docosahexaenoic Acid in Patients With Cystic Fibrosis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 主要终点
- Lipoproteins in Serum (after overnight fast)
研究概览
简要总结
In collaboration with Dr.Birgit Alteheld, Institute of Nutrional Sciences of the university of Bonn, Germany the following effect is explored: Effect of a 4 week therapy with AZT on synthesis of lipoproteins as well as Docosahexaen and other fatty acids in patients with Cystic Fibrosis (CF). Moreover proinflammatory cytokines in blood and sputum are of interest.
详细描述
The macrolide azithromycin (AZT) is recommended by Flume in the CF pulmonary Guidelines for long-term treatment of patients with CF chronically colonized with Pseudomonas aeruginosa due to its immunomodulating properties . AZT causes a significant reduction of the proinflammatory cytokine Lipopolysaccharid binding protein (LBP) according to Steinkamp and Schmitt-Grohé. There is an inverse correlation between LBP and lung function. Moreover Schmitt-Grohé and coworkers provided evidence of a positive correlation between the lipoprotein HDL and lung function. Ribeiro and coworkers found an increased expression of Lipid/Cholesterol genes of primary human airway epithelial cultures after treatment with AZT. Freedman and coworkers were able to show decreased levels of Docosahexaen acid in CF patients.
The aim of this study is to explore the impact of a 4 week trial of AZT on lipoprotein and fatty acids (docosahexaen acid etc.) synthesis.
Delta F508 homozygous patients receive AZT (10 mg/kg body weight resp. max 500 mg) every Monday, Wednesday and Friday for 4 weeks. 20 patients (age 10-60 years) will be recruited. Fatty acids (blood), cytokines (whole blood and induced sputum) and clinical parameters are assessed before and 4 weeks after AZT treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Delta 508 homozygous and regularly visiting the CF outpatient clinic Bonn
排除标准
- •clinical or laboratory signs (CRP > 20 mg/L) of an exacerbation,
- •treatment with systemic steroids 14 days preceeding this trial
- •elevated liver function tests (> twice normal range)
研究组 & 干预措施
Azithromycin
oral Azithromycin 10 mg/kg Body weight, max. 500 mg every Monday, Wednesday and Friday for 4 weeks
干预措施: Azithromycin (Drug)
结局指标
主要结局
Lipoproteins in Serum (after overnight fast)
时间窗: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)
VLDL,LDL,HDL, Cholesterin
Fatty acids in EDTA-Plasma and erythrocyte membranes (after overnight fast)
时间窗: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)
linol acid, arachidon acid, Alpha linolen acid, eicosapentaen acid, Docoshexaen acidsdocosahexaen acid
次要结局
- Cytokines in induced sputum and whole blood(Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment))
- Body weight, length(Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment))
- Lung function test(Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment))
- ICAM1 (Serum)(Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment))
- Matrixmetalloprotease 9 (Serum)(Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment))
- WBC + CRP, IgE, RAST Aspergillus fum, ECP (Serum), Carotin, Vitamin E(Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment))
- Shwachman-Score(Day 0)
- Nutrition protocol(For 7 days before day 0 and day 28)
- Resolvins in EDTA plasma(Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment))
研究者
Sabina Schmitt-Grohe
PD Dr Sabina Schmitt-Grohé
University Childrens' Hospital (Zentrum für Kinderheilkunde des Universitätsklinikum Bonn)