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Effect of Azithromycin on Fatty Acids in CF

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ClinicalTrials.gov Identifier: NCT03045198
Recruitment Status : Enrolling by invitation
First Posted : February 7, 2017
Last Update Posted : August 2, 2018
Sponsor:
Collaborators:
University of Bonn
University Hospital, Frankfurt
Information provided by (Responsible Party):
Sabina Schmitt-Grohe, University Childrens' Hospital (Zentrum für Kinderheilkunde des Universitätsklinikum Bonn)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Azithromycin Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: CF patients receive for 4 weeks Azithromycin. Study measures are assessed before and after 4 weeks
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Azithromycin on Lipoproteins and Docosahexaenoic Acid in Patients With Cystic Fibrosis
Study Start Date : March 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Azithromycin
oral Azithromycin 10 mg/kg Body weight, max. 500 mg every Monday, Wednesday and Friday for 4 weeks
Drug: Azithromycin
Other Name: Zithromax




Primary Outcome Measures :
  1. Lipoproteins in Serum (after overnight fast) [ Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment) ]
    VLDL,LDL,HDL, Cholesterin

  2. Fatty acids in EDTA-Plasma and erythrocyte membranes (after overnight fast) [ Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment) ]
    linol acid, arachidon acid, Alpha linolen acid, eicosapentaen acid, Docoshexaen acidsdocosahexaen acid


Secondary Outcome Measures :
  1. Cytokines in induced sputum and whole blood [ Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment) ]
    Lipopolysaccharid binding Protein (LBP), interleukin-8 (IL-8) und Tumor necrosis factor Alpha (TNF Alpha)

  2. ICAM1 (Serum) [ Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment) ]
  3. Matrixmetalloprotease 9 (Serum) [ Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment) ]
  4. WBC + CRP, IgE, RAST Aspergillus fum, ECP (Serum), Carotin, Vitamin E [ Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment) ]
  5. Shwachman-Score [ Time Frame: Day 0 ]
    Clinical score

  6. Body weight, length [ Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment) ]
  7. Lung function test [ Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment) ]
    VC, FEV1, MEF 25

  8. Nutrition protocol [ Time Frame: For 7 days before day 0 and day 28 ]
    Evaluation of Food intake and calculation of fat composition, Protein etc.

  9. Resolvins in EDTA plasma [ Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045198


Sponsors and Collaborators
University Childrens' Hospital (Zentrum für Kinderheilkunde des Universitätsklinikum Bonn)
University of Bonn
University Hospital, Frankfurt
Investigators
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Principal Investigator: Sabina Schmitt-Grohé, MD University Children's Hospital

Publications:

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Responsible Party: Sabina Schmitt-Grohe, PD Dr Sabina Schmitt-Grohé, University Childrens' Hospital (Zentrum für Kinderheilkunde des Universitätsklinikum Bonn)
ClinicalTrials.gov Identifier: NCT03045198    
Other Study ID Numbers: Sylvia 253/12
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sabina Schmitt-Grohe, University Childrens' Hospital (Zentrum für Kinderheilkunde des Universitätsklinikum Bonn):
cystic fibrosis
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases