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Study of Azithromycin for Lymphocytic Bronchiolitis/Bronchitis After Lung Transplantation

Information source: Katholieke Universiteit Leuven
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphocytic Bronchi(Oli)Tis Post-lung Transplantation

Intervention: Azithromycin Dihydrate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Katholieke Universiteit Leuven

Official(s) and/or principal investigator(s):
Geert M Verleden, MD, PhD, Principal Investigator, Affiliation: KULeuven and UZ Leuven


This study investigates the role of azithromycin treatment for lymphocytic bronchitis/bronchiolitis after lung transplantation.

Clinical Details

Official title: A Prospective, Open-label Study of Azithromycin for Lymphocytic Bronchiolitis/Bronchitis After Lung Transplantation

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Histology on bronchial and/or transbronchial biopsies

Pulmonary function (FEV1)

Bronchoalveolar cellularity and protein levels (IL-8, IL-17)

Radiologic features

Secondary outcome: Pulmonary function (FEV1)

Detailed description: Lymphocytic bronchitis/bronchiolitis is one of the major risk factors for development of chronic rejection/BOS after lung transplantation. There is currently no established treatment available for this condition. There is now mounting evidence that IL-17 producing lymphocytes (TH17) not only participate in chronic allograft rejection/BOS, but are also present within the airway wall during lymphocytic bronchiolitis and that IL-17 mRNA-levels in bronchoalveolar lavage fluid of these patients are upregulated. As such, TH17 may account for the increased BAL neutrophilia seen in these patients, as IL-17 may be responsible for driving IL-8 secretion (a neutrophil-attracting chemokine) from various cell types in the airways. Since azithromycin has previously been shown to reduce both IL-17 induced IL-8 production by human airway smooth muscle cells 'in vitro' and bronchoalveolar IL-8/neutrophil levels in LTx recipients with established BOS, we believe that azithromycin has great potential for treating lymphocytic bronchi(oli)tis by attenuating this TH17/IL-17/IL-8-mediated airway inflammation, possibly even halting the subsequent development of chronic rejection/BOS after lung transplantation. In this study, histologic, spirometric, bronchoalveolar an radiologic features will be investigated in patients treated with confirmed lymphocytic bronchitis/bronchiolitis treated with azithromycin.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Signed informed consent

- Adult (age at least 18 years old at moment of transplantation)

- Able to take oral medication

- Histologic diagnosis of lymphocytic bronchiolitis or bronchitis ('grade B') without

concurrent acute cellular allograft rejection 'grade A' ≥2 Exclusion Criteria:

- Severe suture problems (e. g. airway stenosis) requiring lasering or stenting

Locations and Contacts

University Hospital Gasthuisberg, Leuven, Vlaams-Brabant B-3000, Belgium
Additional Information

Related publications:

Vanaudenaerde BM, De Vleeschauwer SI, Vos R, Meyts I, Bullens DM, Reynders V, Wuyts WA, Van Raemdonck DE, Dupont LJ, Verleden GM. The role of the IL23/IL17 axis in bronchiolitis obliterans syndrome after lung transplantation. Am J Transplant. 2008 Sep;8(9):1911-20. doi: 10.1111/j.1600-6143.2008.02321.x.

Vanaudenaerde BM, Wuyts WA, Geudens N, Dupont LJ, Schoofs K, Smeets S, Van Raemdonck DE, Verleden GM. Macrolides inhibit IL17-induced IL8 and 8-isoprostane release from human airway smooth muscle cells. Am J Transplant. 2007 Jan;7(1):76-82. Epub 2006 Oct 25.

Vanaudenaerde BM, Dupont LJ, Wuyts WA, Verbeken EK, Meyts I, Bullens DM, Dilissen E, Luyts L, Van Raemdonck DE, Verleden GM. The role of interleukin-17 during acute rejection after lung transplantation. Eur Respir J. 2006 Apr;27(4):779-87.

Verleden GM, Vanaudenaerde BM, Dupont LJ, Van Raemdonck DE. Azithromycin reduces airway neutrophilia and interleukin-8 in patients with bronchiolitis obliterans syndrome. Am J Respir Crit Care Med. 2006 Sep 1;174(5):566-70. Epub 2006 Jun 1.

Starting date: April 2010
Last updated: July 3, 2013

Page last updated: August 23, 2015

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