Effect of Azithromycin on Fatty Acids in CF

NCT03045198 | Unknown Phase 4

• 1 other identifier: Sylvia 253/12
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis

Outcome Measures

Primary Outcomes (2)

• Lipoproteins in Serum (after overnight fast)

  VLDL,LDL,HDL, Cholesterin

  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

  Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)

Secondary Outcomes (9)

• Cytokines in induced sputum and whole blood

  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

Study Arms (1)

Azithromycin

EXPERIMENTAL

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

Drug: Azithromycin

Interventions

Azithromycin DRUG

Also known as: Zithromax

Azithromycin

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Childrens' Hospital (Zentrum für Kinderheilkunde des Universitätsklinikum Bonn): lead
• University of Bonn: collaborator
• Goethe University: collaborator

Related Publications (5)

• Freedman SD, Blanco PG, Zaman MM, Shea JC, Ollero M, Hopper IK, Weed DA, Gelrud A, Regan MM, Laposata M, Alvarez JG, O'Sullivan BP. Association of cystic fibrosis with abnormalities in fatty acid metabolism. N Engl J Med. 2004 Feb 5;350(6):560-9. doi: 10.1056/NEJMoa021218.

  PMID: 14762183 BACKGROUND

• Steinkamp G, Schmitt-Grohe S, Doring G, Staab D, Pfrunder D, Beck G, Schubert R, Zielen S. Once-weekly azithromycin in cystic fibrosis with chronic Pseudomonas aeruginosa infection. Respir Med. 2008 Nov;102(11):1643-53. doi: 10.1016/j.rmed.2008.03.009. Epub 2008 Aug 12.

  PMID: 18701270 BACKGROUND

• Schmitt-Grohe S, Hippe V, Igel M, von Bergmann K, Posselt HG, Krahl A, Smaczny C, Wagner TO, Nikolazik W, Schubert R, Lentze MJ, Zielen S. Lipopolysaccharide binding protein, cytokine production in whole blood, and lipoproteins in cystic fibrosis. Pediatr Res. 2005 Nov;58(5):903-7. doi: 10.1203/01.PDR.0000182598.98167.24. Epub 2005 Sep 23.

  PMID: 16183806 BACKGROUND

• Flume PA, O'Sullivan BP, Robinson KA, Goss CH, Mogayzel PJ Jr, Willey-Courand DB, Bujan J, Finder J, Lester M, Quittell L, Rosenblatt R, Vender RL, Hazle L, Sabadosa K, Marshall B; Cystic Fibrosis Foundation, Pulmonary Therapies Committee. Cystic fibrosis pulmonary guidelines: chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2007 Nov 15;176(10):957-69. doi: 10.1164/rccm.200705-664OC. Epub 2007 Aug 29.

  PMID: 17761616 BACKGROUND

• Ribeiro CM, Hurd H, Wu Y, Martino ME, Jones L, Brighton B, Boucher RC, O'Neal WK. Azithromycin treatment alters gene expression in inflammatory, lipid metabolism, and cell cycle pathways in well-differentiated human airway epithelia. PLoS One. 2009 Jun 5;4(6):e5806. doi: 10.1371/journal.pone.0005806.

  PMID: 19503797 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Sabina Schmitt-Grohé, MD

  University Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr Sabina Schmitt-Grohé

Model Details: CF patients receive for 4 weeks Azithromycin. Study measures are assessed before and after 4 weeks

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 7, 2017
• Study Start: March 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-07