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Clinical Trial
. 2010 Feb;45(2):317-24.
doi: 10.1038/bmt.2009.129. Epub 2009 Jun 29.

Influence of oral beclomethasone dipropionate on early non-infectious pulmonary outcomes after allogeneic hematopoietic cell transplantation: results from two randomized trials

J W Chien  1 , M Sakai, T A Gooley, H G Schoch, G B McDonald
Affiliations
Clinical Trial

Influence of oral beclomethasone dipropionate on early non-infectious pulmonary outcomes after allogeneic hematopoietic cell transplantation: results from two randomized trials

J W Chien et al. Bone Marrow Transplant. 2010 Feb.

Abstract

Early non-infectious pulmonary complications represent a significant cause of mortality after hematopoietic cell transplantation (HCT). We tested the hypothesis that oral beclomethasone dipropionate (BDP) is effective for preventing early non-infectious pulmonary complications after allogeneic HCT. We retrospectively reviewed the medical records of 120 patients, 60 in each treatment arm, to identify non-infectious and infectious pulmonary events and pulmonary function test results from all patients who participated in two randomized trials of oral BDP for treatment of acute gastrointestinal GVHD. 17-Beclomethasone monopropionate (17-BMP), the active metabolite of BDP, was evaluated in blood from the right atrium in four patients. Thirty-three of 42 (79%) placebo-treated patients experienced a decrease of the DL(CO) from pretransplant to day 80 after transplant, compared with 27 of 49 (55%) BDP-treated patients (P=0.02). In the first 200 days after randomization, there were no cases of non-infectious pulmonary complications in BDP-treated patients, vs four cases among placebo-treated patients (P=0.04). Levels of 17-BMP were detected in atrial blood at steady state. Delivery of a potent glucocorticoid such as 17-BMP to the pulmonary artery after oral dosing of BDP may be useful in modulating pulmonary inflammation and preventing the development of non-infectious pulmonary complications after allogeneic HCT.

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Figures

Figure 1
Figure 1
Cumulative incidence of non-infectious pulmonary complications after treatment randomization. Prior to day 200 after treatment randomization, no cases of non-infectious pulmonary complications occurred among the BDP-treated patients.
Figure 2
Figure 2
Cumulative incidence of pulmonary infections after treatment randomization. There was not a statistically significant difference in the risk of pulmonary infections between the two treatment groups.
See this image and copyright information in PMC

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