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

NCT ID: NCT00502554

Last Updated: 2011-07-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-03-31

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.

Conditions

Bronchiolitis Obliterans

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Observation with standard care (macrolides, exercise, oxygen therapy etc.) alone.

Group Type: NO_INTERVENTION

photopheresis

Intervention Type: PROCEDURE

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

2

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

Group Type: ACTIVE_COMPARATOR

photopheresis

Intervention Type: PROCEDURE

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

Interventions

photopheresis

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

Intervention Type: PROCEDURE

Other Intervention Names

photopheresis by Therakos

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Therakos

INDUSTRY

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Hannover Medical School

Principal Investigators

Fuehner Thomas, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department Pneumology

Locations

Department Pneumology, Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Medizinische Hochschule Hannover, Dep. Pneumology

Hanover, Lower Saxony, Germany

Countries

Germany

Other Identifiers

4584

Identifier Type: -

Identifier Source: org_study_id