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

Bronchiolitis Obliterans Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00502554
• Other study ID #: 4584
• Status: Terminated
• Phase: N/A
• First received: July 16, 2007
• Last updated: July 25, 2011
• Start date: August 2007
• Est. completion date: March 2010

Study information

• Verified date: May 2008
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans

Intervention

Procedure:
• photopheresis
2-day cycles of photopheresis every 3 weeks for 3 months

Locations

Country	Name	City	State
Germany	Department Pneumology, Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Medizinische Hochschule Hannover, Dep. Pneumology	Hannover	Niedersachsen

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Therakos

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 stabilisation		6 month	Yes