NCT00502554

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 26, 2011

Status Verified

May 1, 2008

Enrollment Period

2.6 years

First QC Date

July 16, 2007

Last Update Submit

July 25, 2011

Conditions

Bronchiolitis Obliterans

Keywords

lung functionFEV1

Outcome Measures

Primary Outcomes (1)

  • FEV1 stabilisation

    6 month

Study Arms (2)

1

NO INTERVENTION

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

Procedure: photopheresis

2

ACTIVE COMPARATOR

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

Procedure: photopheresis

Interventions

photopheresisPROCEDURE

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

Also known as: photopheresis by Therakos
12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • tumor or hematologic disease
  • acute rejection
  • respiratory insufficiency (O2\>2l/min, pCO2 \>50 mm Hg)
  • weight \< 40 kg
  • acute infection
  • colonization with multiresistant pathogens

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department Pneumology, Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Medizinische Hochschule Hannover, Dep. Pneumology

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans

Interventions

Photopheresis

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

PUVA TherapyUltraviolet TherapyPhototherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Fuehner Thomas, Doctor

    Department Pneumology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 17, 2007

Study Start

August 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

July 26, 2011

Record last verified: 2008-05

Locations

DE(2)