Steroid-refractory Bronchiolitis Obliterans Clinical Trial
Official title:
Eine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZT
Improvement of quality of life in patients with BO and establishment of a new third line therapy
Primary Objectives:
Objective improvement of lung function, i.e.:
- Improvement of SO2, pO2 or pCO2 in oxygen dependent or improvement of FiO2 in
respiration dependent patients ≥ 20 % or
- Reduction of oxygen need in oxygen dependent patients ≥ 1L O2/min with constant
parameters at blood gas analysis (BGA) or
- Improvement of obstructive parameters ≥ 20 % or
- Improvement of lung function score (LFS) at least about one grade Improvement of lung
function should be detectable at least by two consecutive examinations of lung function
or BGA within at least four weeks.
Secondary Objectives
- Morphological improvement of BO/BOOP at CT scan
- Reduction of steroids about at least 20 %
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment