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

This study is currently recruiting participants.

Verified by Hannover Medical School, May 2008

First Received: July 16, 2007 Last Updated: May 14, 2008 History of Changes

Sponsors and Collaborators:	Hannover Medical School Therakos
Information provided by:	Hannover Medical School
ClinicalTrials.gov Identifier:	NCT00502554

Purpose

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

Condition	Intervention
Bronchiolitis Obliterans	Procedure: photopheresis

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Lung Transplantation

U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:

FEV1 stabilisation [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention no photopheresis
2: Active Comparator photopheresis	Procedure: photopheresis photopheresis all 3 weeks for 2 days

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502554

Contacts

Contact: Thomas Fuehner, doctor	+49 511 532 3505	fuehner.thomas@mh-hannover.de
Contact: Jens Gottlieb, doctor	+49 511 532 3505	gottlieb.jens@mh-hannover.de

Locations

Germany, Niedersachsen
Medizinische Hochschule Hannover, Dep. Pneumology	Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Fuehner Thomas, Doctor +49
Contact: Gottlieb Jens, Doctor +49 511 532 3505 gottlieb.jens@mh-hannover.de
Department Pneumology, Medizinische Hochschule Hannover	Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Fuehner Thomas, Doctor +49 511 532 3505 fuehner.thomas@mh-hannover.de
Contact: Gottlieb Jens, Doctor +49 511 532 3505 gottlieb.jens@mh-hannover.de

Sponsors and Collaborators

Hannover Medical School

Therakos

Investigators

Principal Investigator:

Fuehner Thomas, Doctor

Department Pneumology

More Information

No publications provided

Responsible Party:	Hannover Medical School ( Department for Respiratory Medicine )
Study ID Numbers:	4584
Study First Received:	July 16, 2007
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00502554 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by Hannover Medical School:

lung function
FEV1

Study placed in the following topic categories:

Lung Diseases, Interstitial
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Bronchiolitis
Bronchitis
Bronchiolitis Obliterans

Additional relevant MeSH terms:

Lung Diseases, Interstitial
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Bronchiolitis
Bronchitis
Bronchiolitis Obliterans

ClinicalTrials.gov processed this record on September 11, 2009