Obstructive Airway Disease Clinical Trial
Official title:
recipientsProspective Evaluation of the Efficacy of Budesonide/Formoterol (Symbicort®) in Bronchiolitis Obliterans in Allogeneic Haematopoietic Stem Cell Transplantation (AHSCT) Recipients
The usual treatment for obstructive airway disease (OAD) after allogeneic hematopoietic stem cell transplantation (AHSCT) , which is related to graft versus host disease (GVHD), consists of intensification of systemic immunosuppressive therapy.
Although it has not been evaluated prospectively, the usual treatment for obstructive airway
disease (OAD) after allogeneic hematopoietic stem cell transplantation (AHSCT) , which is
related to graft versus host disease (GVHD), 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 necessary.We have retrospectively reported clinical and functional
improvement in patients with OAD following AHSCT treated with inhaled budesonide/formoterol
combination.These encouraging results need to be confirmed by the present randomised,
prospective double-blind trial. This study is therefore designed to evaluate the efficacy of
budesonide/formoterol versus placebo in patients with moderate to severe OAD, not requiring
initiation or intensification of systemic immunosuppressive therapy for extra thoracic GVHD.
Inclusion criteria modified according to amendment of 02/11/2009
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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