Study of Azithromycin for Lymphocytic Bronchiolitis/Bronchitis After Lung Transplantation (AZI002)
Recruitment status was Recruiting
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Purpose
This study investigates the role of azithromycin treatment for lymphocytic bronchitis/bronchiolitis after lung transplantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphocytic Bronchi(Oli)Tis Post-lung Transplantation |
Drug: Azithromycin Dihydrate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Open-label Study of Azithromycin for Lymphocytic Bronchiolitis/Bronchitis After Lung Transplantation |
- Histology on bronchial and/or transbronchial biopsies [ Time Frame: after 3 months of treatment ] [ Designated as safety issue: No ]Evolution of lymphocytic airway inflammation after 3 months of treatment
- Pulmonary function (FEV1) [ Time Frame: after 3 months of treatment ] [ Designated as safety issue: Yes ]Evolution of FEV1 after 3 months of treatment
- Bronchoalveolar cellularity and protein levels (IL-8, IL-17) [ Time Frame: after 3 months of treatment ] [ Designated as safety issue: No ]Evolution of bronchoalveolar cellularity and protein levels (IL-8, IL-17) after 3 months of treatment
- Radiologic features [ Time Frame: after 3 months of treatment ] [ Designated as safety issue: No ]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
- Pulmonary function (FEV1) [ Time Frame: after 6 months of treatment ] [ Designated as safety issue: No ]Evolution of FEV1 after 6 months of treatment
- Bronchoalveolar cellularity and protein levels [ Time Frame: after 6 months of treatment ] [ Designated as safety issue: No ]Evolution of bronchoalveolar cellularity and protein levels after 6 months of treatment
- Radiologic features [ Time Frame: after 6 months of treatment ] [ Designated as safety issue: No ]Evolution of radiologic features on chest X-ray or HRCT after 6 months of treatment
- Pulmonary function (FEV1) [ Time Frame: after 1 year of treatment ] [ Designated as safety issue: No ]Evolution of FEV1 after 1 year of treatment
- Bronchoalveolar cellularity and protein levels [ Time Frame: after 1 year of treatment ] [ Designated as safety issue: No ]Evolution of bronchoalveolar cellularity and protein levels after 1 year of treatment
- Radiologic features [ Time Frame: after 1 year of treatment ] [ Designated as safety issue: Yes ]Evolution of radiologic features on chest X-ray or HRCT after 1 year of treatment.
- Prevalence of chronic rejection (diagnosed as bronchiolitis obliterans syndrome, BOS) [ Time Frame: after 1 year of treatment ] [ Designated as safety issue: No ]Prevalence of chronic rejection (diagnosed as BOS) after 1 year of treatment
- Prevalence of chronic rejection (diagnosed as bronchiolitis obliterans syndrome or BOS) [ Time Frame: 2 years after initiation of treatment ] [ Designated as safety issue: No ]Prevalence of chronic rejection (diagnosed as BOS) 2 years after initiation of treatment
- Overall survival [ Time Frame: after 1 year of treatment ] [ Designated as safety issue: No ]Overall survival after 1 year of treatment
- Overall survival [ Time Frame: 2 years after initiation of treatment ] [ Designated as safety issue: No ]Overall survival 2 years after initiation of treatment
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Azithromycin
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 (1 year 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 (1 year treatment). Other Name: Azithromycin 250 mg, ZTM250, Zitromax TM (ATC J01FA10)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Geert M Verleden, MD, PhD | +32 16 34 68 08 ext Prof. Dr. | geert.verleden@uzleuven.be |
| Contact: Bart M Vanaudenaerde, PhD | +32 16 33 01 95 ext Dr. | bart.vanaudenaerde@med.kuleuven.be |
| Belgium | |
| University Hospital Gasthuisberg | Recruiting |
| Leuven, Vlaams-Brabant, Belgium, B-3000 | |
| Contact: Geert M Verleden, Md, PhD +32 16 34 68 08 ext Prof. Dr. geert.verleden@uzleuven.be | |
| Contact: Bart M Vanaudenaerde, PhD +32 16 33 01 95 ext Dr. bart.vanaudenaerde@med.kuleuven.be | |
| Principal Investigator: Geert M Verleden, MD, PhD | |
| Sub-Investigator: Bart M Vanaudenaerde, PhD | |
| Sub-Investigator: Robin Vos, MD | |
| Sub-Investigator: Lieven J Dupont, MD, PhD | |
| Principal Investigator: | Geert M Verleden, MD, PhD | KULeuven and UZ Leuven |
More Information
Publications:
| Responsible Party: | Prof. Dr. GM. Verleden, KULeuven and University Hospitals Leuven |
| ClinicalTrials.gov Identifier: | NCT01109160 History of Changes |
| Other Study ID Numbers: | AZI002, 2010-018724-16 |
| Study First Received: | April 21, 2010 |
| Last Updated: | April 22, 2010 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by Katholieke Universiteit Leuven:
|
azithromycin lymphocytic bronchitis or bronchiolitis lung transplantation |
acute allograft rejection chronic allograft rejection bronchiolitis obliterans syndrome |
Additional relevant MeSH terms:
|
Bronchitis Bronchiolitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Tract Infections Azithromycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013