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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BUDESONIDE/FORMOTEROL | Active Comparator |
| |
| control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/formoterol | Drug | 800 µg/j twice a day, every day |
|
| Measure | Description | Time Frame |
|---|---|---|
| pulmonary function tests | 1 month | |
| Dyspnea based on NYHA classification | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| pulmonary function test | 7 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| bergeron-lafaurie Anne, MD, PhD | Pneumology Department, Hopital Saint Louis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Saint Louis APHP | Paris | 75010 | France |
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| ID | Term |
|---|---|
| D001989 | Bronchiolitis Obliterans |
| D008173 | Lung Diseases, Obstructive |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Placebo | Drug | Twice a day, every day |
|
| D008171 |
| Lung Diseases |
| D009930 |
| Organic Chemicals |
| D000588 | Amines |
| D019819 | Budesonide |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |