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

Hannover Medical School12 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bronchiolitis Obliterans

Interventions

photopheresisPROCEDURE

2-day cycles of photopheresis every 3 weeks for 3 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Department Pneumology, Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Medizinische Hochschule Hannover, Dep. Pneumology

Hanover, Lower Saxony, Germany

Outcomes

Primary Outcomes

FEV1 stabilisation

Time frame: 6 month

Data from ClinicalTrials.gov

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