52739
document
Evaluation of oral beclomethasone dipropionate for prevention of acute graft-versus-host disease . Results from two randomized trials have shown that oral beclomethasone dipropionate ( BDP ) is effective for treatment of acute gastrointestinal graft-versus-host disease . Here , we report results of a double-blind , randomized placebo-controlled phase II study designed to test the hypothesis that acute graft-versus-host disease could be prevented by administration of oral BDP , beginning before hematopoietic cell transplantation and continuing until day 75 after hematopoietic cell transplantation after myeloablative conditioning . Study drug ( BDP or placebo ) was administered as 1-mg immediate-release formulation plus 1-mg delayed-release formulation orally four times daily . According to the primary endpoint , systemic glucocorticoid treatment for graft-versus-host disease was given to 60 of the 92 participants ( 65 % ) in the BDP arm , versus 31 of 46 participants ( 67 % ) in the placebo arm . The secondary efficacy endpoints showed no statistically significant differences between the two arms . The proportion of participants who took at least 90 % of the prescribed study drug during the first 4 weeks after hematopoietic cell transplantation was 54 % overall . Lower severity of mucositis strongly correlated with higher adherence to the schedule of study drug administration . Inconsistent adherence related to mucositis during recovery after myeloablative conditioning may have obscured a beneficial therapeutic effect in the current study .
52740
Intervention_Pharmacological
beclomethasone dipropionate
52741
Intervention_Pharmacological
oral beclomethasone dipropionate ( BDP )
52742
Intervention_Pharmacological
oral BDP
52743
Intervention_Pharmacological
BDP
52744
Intervention_Control
placebo
52745
Intervention_Pharmacological
glucocorticoid
52746
Intervention_Pharmacological
BDP
52747
Intervention_Control
placebo
52748
Intervention_Surgical
hematopoietic cell transplantation
52749
Outcome_Other
systemic glucocorticoid treatment
52750
Outcome_Other
secondary efficacy endpoints
52751
Outcome_Other
no statistically significant differences
52752
Outcome_Adverse-effects
severity of mucositis
52753
Outcome_Mental
adherence
52754
Outcome_Mental
adherence