Back to resultsExtracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation
Primary Purpose
Bronchiolitis Obliterans
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
photopheresis
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis Obliterans focused on measuring lung function, FEV1
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
Sites / Locations
- Department Pneumology, Medizinische Hochschule Hannover
- Medizinische Hochschule Hannover, Dep. Pneumology
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
1
2
Arm Description
Observation with standard care (macrolides, exercise, oxygen therapy etc.) alone.
2-day cycles of photopheresis every 3 weeks for 3 months
Outcomes
Primary Outcome Measures
FEV1 stabilisation
Secondary Outcome Measures
Full Information
NCT ID
NCT00502554
First Posted
July 16, 2007
Last Updated
July 25, 2011
Sponsor
Hannover Medical School
Collaborators
Mallinckrodt
1. Study Identification
Unique Protocol Identification Number
NCT00502554
Brief Title
Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation
Official Title
Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Terminated
Why Stopped
insufficient patient recruitment and ECP capacity
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hannover Medical School
Collaborators
Mallinckrodt
4. Oversight
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis Obliterans
Keywords
lung function, FEV1
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
Observation with standard care (macrolides, exercise, oxygen therapy etc.) alone.
Arm Title
2
Arm Type
Active Comparator
Arm Description
2-day cycles of photopheresis every 3 weeks for 3 months
Intervention Type
Procedure
Intervention Name(s)
photopheresis
Other Intervention Name(s)
photopheresis by Therakos
Intervention Description
2-day cycles of photopheresis every 3 weeks for 3 months
Primary Outcome Measure Information:
Title
FEV1 stabilisation
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuehner Thomas, Doctor
Organizational Affiliation
Department Pneumology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department Pneumology, Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Dep. Pneumology
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation
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