Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Open-labeled Trial to Evaluate the Therapeutic Effects of Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans After Allogeneic Stem Cell Transplantation

Conditions
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Bronchiolitis Obliterans, Allogeneic Stem Cell Transplantation

Intervention / Treatment
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* Drug: Budesonide/formoterol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BUDESONIDE/FORMOTEROL<br> | Drug: Budesonide/formoterol<br>* 800 µg/j twice a day, every day<br>* Other names: Symbicort;|
| Placebo Comparator: control<br> | Drug: Placebo<br>* Twice a day, every day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function tests |  | 1 month | 
| Dyspnea based on NYHA classification |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function test |  | 7 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone marrow transplantation, obstructive lung disease, bronchodilators, inhaled steroids, late-onset pulmonary complication