Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation

Study Overview
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Brief Summary
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Investigation of photopheresis as new therapy regimen in patients with bronchiolitis obliterans syndrome after lung transplantation in a controlled, randomized study

Detailed Description
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Bronchiolitis obliterans syndrome is the major cause of mortality after lung transplantation. 5 years after lung transplantation about 50% of all patients have this syndrome. There are nearly none therapy options. Besides effective therapy of any gastrooesophageal reflux and an oral medication with azithromycin none further regimens are known. Photopheresis could show in several studies a benefit for patients with gvhd after bone marrow transplantation or for chronic rejection after any other solid organ transplantation. Just little case reports could show beneficial effect in patients with bos after lung transplantation. This is the first controlled, randomized study with patients with bos after lung transplantation to investigate the effectiveness of this therapy in that patients.

Official Title
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Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation

Conditions
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Bronchiolitis Obliterans

Intervention / Treatment
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* Procedure: photopheresis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single/Double lung transplantation at least 6 months after lung transplantation bronchiolitis obliterans syndrome, Stadium > 1 (nach ISHLT 2001, FEV1 <80% Best), none other reason for worsening lung function (eg acute rejection, infection, extrapulmonary reasons, airway obstruction) none gastroesophageal reflux medication for > 3 months with Azithromycin with further decrease of FEV1, MEF 25-75 bioptic prove that there is no acute rejection no improvement under steroid pulse therapy Exclusion Criteria: tumor or hematologic disease acute rejection respiratory insufficiency (O2>2l/min, pCO2 >50 mm Hg) weight < 40 kg acute infection colonization with multiresistant pathogens

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Observation with standard care (macrolides, exercise, oxygen therapy etc.) alone. | Procedure: photopheresis<br>* 2-day cycles of photopheresis every 3 weeks for 3 months<br>* Other names: photopheresis by Therakos;|
| Active Comparator: 2<br>2-day cycles of photopheresis every 3 weeks for 3 months | Procedure: photopheresis<br>* 2-day cycles of photopheresis every 3 weeks for 3 months<br>* Other names: photopheresis by Therakos;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 stabilisation |  | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung function, FEV1