Allogeneic Stem Cell Transplantation, Bronchiolitis Obliterans
Conditions
Keywords
bone marrow transplantation, obstructive lung disease, bronchodilators, inhaled steroids, late-onset pulmonary complication
Brief summary
The purpose of this study is to determine whether inhaled Budesonide/formoterol is effective in the treatment of bronchiolitis obliterans after allogeneic stem cell transplantation.
Detailed description
Bronchiolitis obliterans (BO) is a life-threatening pulmonary late-onset complication following allogenic stem cell transplantation (SCT), commonly attributed to graft versus host disease (GVHD), and carries a poor prognosis. Although immunosuppressive treatments (IS) represents the main therapeutic approach in this disorder, these medications are rarely efficient and alternative approaches are strongly needed. Because, the combination of inhaled steroids and long-acting bronchodilator are known to decrease respiratory symptoms, prevent exacerbations and improve lung function in chronic obstructive pulmonary diseases with bronchiolar component, they may have beneficial effects in BO. Thus, the investigators conducted a pilot open-labeled trial to evaluate the therapeutic effects of inhaled Budesonide/Formoterol combination (400/12 µg twice a day) without modifying systemic IS received by the patients.
Interventions
800 µg/j twice a day, every day
Twice a day, every day
Sponsors
Study design
Eligibility
Inclusion criteria
* adult allogeneic stem cell transplant recipients with clinical respiratory signs assumed to be secondary to BO, without extra-thoracic extensive graft versus host disease
Exclusion criteria
* Extensive extra thoracic GVH necessitating increasing immunosuppressive treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pulmonary function tests | 1 month |
| Dyspnea based on NYHA classification | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| pulmonary function test | 7 month |
Countries
France