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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00502554

Enrollment

Registered

2007-07-17

Start date

2007-08-31

Completion date

2010-03-31

Last updated

2011-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis Obliterans

Keywords

lung function, FEV1

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.

Interventions

PROCEDUREphotopheresis

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
FEV1 stabilisation	6 month

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026