A Phase 4 interventional study of Azithromycin Dihydrate in Lymphocytic Bronchi(Oli)Tis Post-lung Transplantation, sponsored by KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-04.
Sponsored by KU Leuven · Phase 4, Interventional, and Treatment
This study investigates the role of azithromycin treatment for lymphocytic bronchitis/bronchiolitis after lung transplantation.
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.
360 studies on the registry are indexed under Bronchiolitis; 43 are open to participants now.
This study's enrollment of 15 is below the median of 80 across 249 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.
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Exclusion Criteria:
Add-on of study-drug (azithromycin) to 'standard of care': 250 mg daily for 5 days, followed by 250 mg every other day until the end of the study-period (6 months treatment).
Drug: Azithromycin Dihydrate
Add-on of study-drug (azithromycin) to 'standard of care' at diagnosis of lymphocytic bronchi(oli)tis. Study-drug regime: 250 mg daily for 5 days, followed by 250 mg every other day until the end of the study-period (6 months treatment).
Also known as: Azithromycin 250 mg, ZTM250, Zitromax TM (ATC J01FA10)
Histology on bronchial and/or transbronchial biopsies
Evolution of lymphocytic airway inflammation after 3 months of treatment
Time frame: after 3 months of treatment
Pulmonary function (FEV1)
Evolution of FEV1 after 3 months of treatment
Time frame: after 3 months of treatment
Bronchoalveolar cellularity and protein levels (IL-8, IL-17)
Evolution of bronchoalveolar cellularity and protein levels (IL-8, IL-17) after 3 months of treatment
Time frame: after 3 months of treatment
Radiologic features
Evolution of radiologic features (e.g. tree-in-bud, consolidation, bronchiectasis, air trapping, etc.) on chest X-ray or HRCT after 3 months of treatment
Time frame: after 3 months of treatment
Pulmonary function (FEV1)
Evolution of FEV1 after 6 months of treatment
Time frame: after 6 months of treatment
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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