Effect of Azithromycin on Fatty Acids in CF

University Childrens' Hospital (Zentrum für Kinderheilkunde des Universitätsklinikum Bonn)

Status and phase: Unknown; Phase 4

Conditions: Cystic Fibrosis

Treatments: Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT03045198

Sylvia 253/12

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 10 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Delta 508 homozygous and regularly visiting the CF outpatient clinic Bonn

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Azithromycin

Experimental group

Description:

oral Azithromycin 10 mg/kg Body weight, max. 500 mg every Monday, Wednesday and Friday for 4 weeks

Treatment:

Drug: Azithromycin