[Prospective evaluation of the efficacy of the combination of budesonide/formoterol in obstructive airway disease after allogeneic hematopoietic stem cell transplantation].
BACKGROUND
Although it has not been evaluated prospectively, the usual treatment for obstructive airway disease after allogeneic hematopoietic stem cell transplantation, which is related to graft versus host disease, consists of intensification of systemic immunosuppressive therapy. However, this treatment has a limited efficacy and is associated with a significant number of serious adverse effects, particularly infectious. Alternative treatments are therefore required. Recently, clinical and functional improvement in patients with obstructive airway disease following allogenic hematopoietic stem cell transplantation treated with inhaled combined Budesonide/Formoterol has been retrospectively reported.


METHODS
The present prospective multi-centered, randomised double-blind trial is designed to evaluate the efficacy of the combination of budesonide/formoterol (400/12 microg 2 inhalations bid) versus placebo in patients with moderate to severe obstructive airway disease, not requiring initiation or intensification of systemic immunosuppressive therapy for extra thoracic graft versus host disease. The primary outcome will be the improvement of FEV1 at 1 month of treatment. The secondary outcomes will be the clinical and functional pulmonary improvements at 6 months.


RESULTS
The leading hypothesis is that patients treated with inhaled combined Budesonide/Formoterol will show significant improvement of their clinical symptoms and pulmonary functional testing.
Bergeron
A
A
Service de Pneumologie, Hôpital Saint-Louis, Assistance Publique- Hôpitaux de Paris, Université Denis Diderot, Paris 7, Paris, France. anne.bergeron-lafaurie@sls.aphp.fr
Chagnon
K
K
Feuillet
S
S
Chevret
S
S
Tazi
A
A
D000280:Administration, Inhalation; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000328:Adult; D000402:Airway Obstruction / Q000188:drug therapy*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D019819:Budesonide / Q000008:administration & dosage* / Q000627:therapeutic use; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D004338:Drug Combinations; D004417:Dyspnea / Q000175:diagnosis; D004983:Ethanolamines / Q000008:administration & dosage* / Q000627:therapeutic use*; D005500:Follow-Up Studies; D000068759:Formoterol Fumarate; D005938:Glucocorticoids / Q000008:administration & dosage*; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D008173:Lung Diseases, Obstructive / Q000188:drug therapy*; D010919:Placebos; D011446:Prospective Studies; D012129:Respiratory Function Tests; D018709:Statistics, Nonparametric; D013997:Time Factors; D014184:Transplantation, Homologous; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D004338:Drug Combinations; D004983:Ethanolamines; D005938:Glucocorticoids; D010919:Placebos; D019819:Budesonide; D000068759:Formoterol Fumarate