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

This study has been terminated.
(insufficient patient recruitment and ECP capacity)
Sponsor:
Collaborator:
Therakos
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00502554
First received: July 16, 2007
Last updated: July 25, 2011
Last verified: May 2008
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • FEV1 stabilisation [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: August 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: photopheresis by Therakos

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Medizinische Hochschule Hannover, Dep. Pneumology
Hannover, Niedersachsen, Germany, 30625
Department Pneumology, Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Therakos
Investigators
Principal Investigator: Fuehner Thomas, Doctor Department Pneumology
  More Information

No publications provided

Responsible Party: Department for Respiratory Medicine, Hannover Medical School
ClinicalTrials.gov Identifier: NCT00502554     History of Changes
Other Study ID Numbers: 4584
Study First Received: July 16, 2007
Last Updated: July 25, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Hannover Medical School:
lung function
FEV1

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on September 14, 2014