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Randomized trial of inhaled beclomethasone dipropionate versus theophylline for moderate asthma during pregnancy.

Author(s): Dombrowski MP, Schatz M, Wise R, Thom EA, Landon M, Mabie W, Newman RB, McNellis D, Hauth JC, Lindheimer M, Caritis SN, Leveno KJ, Meis P, Miodovnik M, Wapner RJ, Varner MW, O'Sullivan MJ, Conway DL, National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, National Heart, Lung, and Blood Institute

Affiliation(s): Department of Obstetrics and Gynecology, Wayne State University, Detroit, Mich, USA. Mitchell.Dombrowski@stjohn.org

Publication date & source: 2004-03, Am J Obstet Gynecol., 190(3):737-44.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

OBJECTIVE: This study was undertaken to compare the efficacy of inhaled beclomethasone dipropionate to oral theophylline for the prevention of asthma exacerbation(s) requiring medical intervention. STUDY DESIGN: A prospective, double-blind, double placebo-controlled randomized clinical trial of pregnant women with moderate asthma was performed. RESULTS: There was no significant difference (P=.554) in the proportion of asthma exacerbations among the 194 women in the beclomethasone cohort (18.0%) versus the 191 in the theophylline cohort (20.4%; risk ratio [RR]=0.9, 95% CI=0.6-1.3). The beclomethasone cohort had significantly lower incidences of discontinuing study medications caused by side effects (RR=0.3, 95% CI=0.1-0.9; P=.016), and proportion of study visits with forced expiratory volume expired in 1 second (FEV1) less than 80% predicted (0.284+/-0.331 vs 0.284+/-0.221, P=.039). There were no significant differences in treatment failure, compliance, or proportion of peak expiratory flow rate less than 80% predicted. There were no significant differences in maternal or perinatal outcomes. CONCLUSION: The treatment of moderate asthma with inhaled beclomethasone versus oral theophylline resulted in similar rates of asthma exacerbations and similar obstetric and perinatal outcomes. These results favor the use of inhaled corticosteroids for moderate asthma during pregnancy because of the improved FEV1 and because theophylline had more side effects and requires serum monitoring.

Page last updated: 2006-01-31

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