Source: Annual Congress 2002 - Asthma - Therapy and management -3
Disease area: Airway diseases, Paediatric lung diseases

Abstract

Introduction: The START study is the first worldwide, randomized, prospective asthma study investigating early intervention with ICS in newly diagnosed asthmatics, including 7165 subjects in 32 countries over a 3-year double-blind period and 2-year open-label period.
Methods: Treatment with budesonide (Pulmicort® Turbuhaler®) was compared with placebo in addition to their usual asthma medications. The budesonide dose was 400 μg for adults. The present material from the START study included 2473 women aged 15-50 years. Two hundred and twenty-one pregnancy reports were recieved from 202 women who became pregnant during the double-blind part of the study. Pregnancy was not an exclusion criterion.
Results: Of the 104 pregnancies reported by patients taking budesonide, 22 were terminated due to spontaneous abortion or extrauterine pregnancies, while in the placebo group 20 of the 117 pregnacies were terminated for these reasons. The number of congenital malformations was one in the budesonide group vs four in the placebo group. Healthy children were delivered in 75% and 77% of all pregnancies for budesonide and placebo, respectively. These results correspond with data from the Swedish registry studies in more than 2500 pregnancies that showed normal rate of malformations in children exposed to inhaled budesonide during the first trimester, however the START study is unique in that exposure was over the entire pregnancy in a global, prospective, randomized study.
Conclusion: Although the study is underpowered to identify small differences in pregnancy outcome, the results suggest that treatment of this asthmatic population with a low dose of budesonide is safe.

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Prospective pregnancy outcome data from the START study. On behalf of the START safety committee. Eur Respir J 2002; 20: Suppl. 38, 442

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