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

Hannover Medical School (MHH)

Status: Terminated

Conditions: Bronchiolitis Obliterans

Treatments: Procedure: photopheresis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00502554

4584

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

1

No Intervention group

Description:

Observation with standard care (macrolides, exercise, oxygen therapy etc.) alone.

Treatment:

Procedure: photopheresis

2

Active Comparator group

Description:

2-day cycles of photopheresis every 3 weeks for 3 months

Treatment:

Procedure: photopheresis