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

July 25, 2011 updated by: Hannover Medical School
Investigation of photopheresis as new therapy regimen in patients with bronchiolitis obliterans syndrome after lung transplantation in a controlled, randomized study

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Department Pneumology, Medizinische Hochschule Hannover
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover, Dep. Pneumology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: 1
Observation with standard care (macrolides, exercise, oxygen therapy etc.) alone.
Procedure: photopheresis
2-day cycles of photopheresis every 3 weeks for 3 months
Other Names:
  • photopheresis by Therakos
ACTIVE_COMPARATOR: 2
2-day cycles of photopheresis every 3 weeks for 3 months
Procedure: photopheresis
2-day cycles of photopheresis every 3 weeks for 3 months
Other Names:
  • photopheresis by Therakos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FEV1 stabilisation
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Collaborators

Mallinckrodt

Investigators

  • Principal Investigator: Fuehner Thomas, Doctor, Department Pneumology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

July 16, 2007

First Submitted That Met QC Criteria

July 16, 2007

First Posted (ESTIMATE)

July 17, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2011

Last Update Submitted That Met QC Criteria

July 25, 2011

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4584

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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