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Cystic FibrosisPhase 4NCT03045198

Effect of Azithromycin on Fatty Acids in CF

A Phase 4 study testing Azithromycin in people with Cystic Fibrosis, run by University Childrens' Hospital (Zentrum für Kinderheilkunde des Universitätsklinikum Bonn).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 10 to 60 years
Conditions the study is for
Cystic Fibrosis
What is being tested?
Azithromycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Mar 2012to Dec 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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)

About this study

Official title: Effect of Azithromycin on Lipoproteins and Docosahexaenoic Acid in Patients With Cystic Fibrosis

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.

Read the 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.

Conditions
Cystic Fibrosis
Being tested
Azithromycin
Keywords
cystic fibrosis
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03045198
Study groupRoleWhat they receive
AzithromycinExperimentaloral Azithromycin 10 mg/kg Body weight, max. 500 mg every Monday, Wednesday and Friday for 4 weeks
Receives: Drug: Azithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lipoproteins in Serum (after overnight fast)

    VLDL,LDL,HDL, Cholesterin

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

  2. Fatty acids in EDTA-Plasma and erythrocyte membranes (after overnight fast)

    linol acid, arachidon acid, Alpha linolen acid, eicosapentaen acid, Docoshexaen acidsdocosahexaen acid

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

Secondary outcomes (9)

  1. Cytokines in induced sputum and whole blood

    Lipopolysaccharid binding Protein (LBP), interleukin-8 (IL-8) und Tumor necrosis factor Alpha (TNF Alpha)

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

  2. ICAM1 (Serum)

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

  3. Matrixmetalloprotease 9 (Serum)

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

  4. WBC + CRP, IgE, RAST Aspergillus fum, ECP (Serum), Carotin, Vitamin E

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

  5. Shwachman-Score

    Clinical score

    Measured: Day 0

  6. Body weight, length

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

  7. Lung function test

    VC, FEV1, MEF 25

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

  8. Nutrition protocol

    Evaluation of Food intake and calculation of fat composition, Protein etc.

    Measured: For 7 days before day 0 and day 28

  9. Resolvins in EDTA plasma

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2017 (estimated)
  2. Study startMar 2012
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
CF patients receive for 4 weeks Azithromycin. Study measures are assessed before and after 4 weeks
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03045198
Sponsor's protocol ID
Sylvia 253/12
Status last verified
Jul 2018
First submitted
2 Feb 2017
Last updated
2 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 14762183

  • 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.

    PubMed 18701270

  • 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.

    PubMed 16183806

  • 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.

    PubMed 17761616

  • 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.

    PubMed 19503797

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Azithromycin in people with Cystic Fibrosis, run by University Childrens' Hospital (Zentrum für Kinderheilkunde des Universitätsklinikum Bonn).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lipoproteins in Serum (after overnight fast) (time frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03045198, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.

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