JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

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

Mitchell P Dombrowski, Michael Schatz, Robert Wise, Elizabeth A Thom, Mark Landon, William Mabie, Roger B Newman, Donald McNellis, John C Hauth, Marshall Lindheimer, Steve N Caritis, Kenneth J Leveno, Paul Meis, Menachem Miodovnik, Ronald J Wapner, Michael W Varner, Mary Jo O'Sullivan, Deborah L Conway
American Journal of Obstetrics and Gynecology 2004, 190 (3): 737-44
15042007

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.

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