Open-labeled Trial to Evaluate the Therapeutic Effects of Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans After Allogeneic Stem Cell Transplantation
Overview
- Phase
- Phase 2
- Intervention
- Budesonide/formoterol
- Conditions
- Bronchiolitis Obliterans
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- pulmonary function tests
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Anne Bergeron
MD, PhD
Assistance Publique - Hôpitaux de Paris
Eligibility Criteria
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
Arms & Interventions
BUDESONIDE/FORMOTEROL
Intervention: Budesonide/formoterol
control
Intervention: Placebo
Outcomes
Primary Outcomes
pulmonary function tests
Time Frame: 1 month
Dyspnea based on NYHA classification
Time Frame: 1 month
Secondary Outcomes
- pulmonary function test(7 month)