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

Sponsor
Hannover Medical School (Other)
Overall Status
Terminated
CT.gov ID
NCT00502554
Collaborator
Mallinckrodt (Industry)
12
Enrollment
2
Locations
2
Arms
31
Duration (Months)
6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: photopheresis
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation
Study Start Date :
Aug 1, 2007
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. FEV1 stabilisation [6 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Department Pneumology, Medizinische Hochschule Hannover Hannover Niedersachsen Germany 30625
    2 Medizinische Hochschule Hannover, Dep. Pneumology Hannover Niedersachsen Germany 30625

    Sponsors and Collaborators

    • Hannover Medical School
    • Mallinckrodt

    Investigators

    • Principal Investigator: Fuehner Thomas, Doctor, Department Pneumology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00502554
    Other Study ID Numbers:
    • 4584
    First Posted:
    Jul 17, 2007
    Last Update Posted:
    Jul 26, 2011
    Last Verified:
    May 1, 2008
    Keywords provided by , ,
    lung function
    FEV1
    Additional relevant MeSH terms:
    Bronchiolitis
    Bronchiolitis Obliterans

    Study Results

    No Results Posted as of Jul 26, 2011