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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Lipoproteins in Serum (after overnight fast)
VLDL,LDL,HDL, Cholesterin
Time frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)
Fatty acids in EDTA-Plasma and erythrocyte membranes (after overnight fast)
linol acid, arachidon acid, Alpha linolen acid, eicosapentaen acid, Docoshexaen acidsdocosahexaen acid
Time frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)
Cytokines in induced sputum and whole blood
Lipopolysaccharid binding Protein (LBP), interleukin-8 (IL-8) und Tumor necrosis factor Alpha (TNF Alpha)
Time frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)
ICAM1 (Serum)
Time frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)
Matrixmetalloprotease 9 (Serum)
Time frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)
WBC + CRP, IgE, RAST Aspergillus fum, ECP (Serum), Carotin, Vitamin E
Time frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)
Shwachman-Score
Clinical score
Time frame: Day 0
Body weight, length
Time frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)
Lung function test
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
VC, FEV1, MEF 25
Time frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)
Nutrition protocol
Evaluation of Food intake and calculation of fat composition, Protein etc.
Time frame: For 7 days before day 0 and day 28
Resolvins in EDTA plasma
Time frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)