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

Not Applicable

Terminated

• Conditions: Bronchiolitis Obliterans
• Interventions: Procedure: photopheresis

• Registration Number: NCT00502554
• Lead Sponsor: Hannover Medical School

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-16
• Study First Posted: 2007-07-17
• Study Start: 2007-08
• Status Verified: 2008-05
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2011-07-25
• Last Update Posted: 2011-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	photopheresis	2-day cycles of photopheresis every 3 weeks for 3 months
1	photopheresis	Observation with standard care (macrolides, exercise, oxygen therapy etc.) alone.

Primary Outcome Measures

Name	Time	Method
FEV1 stabilisation	6 month

Trial Locations

Locations (2)

Medizinische Hochschule Hannover, Dep. Pneumology; 🇩🇪 Hannover, Niedersachsen, Germany

Department Pneumology, Medizinische Hochschule Hannover; 🇩🇪 Hannover, Niedersachsen, Germany