ORIGINAL ARTICLES
Outcome of pregnancy in a randomized controlled study of patients with asthma exposed to budesonide

https://doi.org/10.1016/S1081-1206(10)61020-4Get rights and content

Background

Budesonide is the only inhaled corticosteroid to be given a category B pregnancy rating by the US Food and Drug Administration, based on observational data from the Swedish Medical Birth Registry. However, data from large randomized controlled trials are lacking.

Objective

To compare pregnancy outcomes among patients with recent-onset mild-to-moderate persistent asthma receiving low-dose budesonide vs placebo.

Methods

In a randomized, double-blind, placebo-controlled trial, 7,241 patients aged 5 to 66 years with mild-to-moderate persistent asthma for less than 2 years and no previous regular corticosteroid therapy received once-daily budesonide or placebo via dry powder inhaler in addition to their usual asthma medication for 3 years. This trial was followed by a 2-year open-label treatment period. The daily dose of budesonide was 400 μg for adults. The study included 2,473 females aged 15 to 50 years at randomization. Pregnancy was not an exclusion criterion (except for US patients).

Results

Of 319 pregnancies reported, 313 were analyzed. Healthy children were delivered in 81% and 77% of all pregnancies in the budesonide and placebo groups, respectively. Of the 196 pregnancies reported by participants taking budesonide, 38 (19%) had adverse outcomes: 23 (12%) had miscarriages, 3 (2%) had congenital malformations, and 12 (6%) had other outcomes. Of the 117 pregnancies reported in the placebo group, 27 (23%) had adverse outcomes: 11 (9%) had miscarriages, 4 (3%) had congenital malformations, and 12 (10%) had other outcomes.

Conclusions

Treatment with low-dose inhaled budesonide in females with mild-to-moderate persistent asthma does not seem to affect the outcome of pregnancy.

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      Citation Excerpt :

      Most data on asthma treatment during pregnancy are derived from cohort studies. However, one randomized controlled trial of low-dose budesonide (400 μg/d) versus placebo among patients with recent-onset mild to moderate asthma included a subgroup of 313 pregnant women.120 The rate of adverse pregnancy outcomes (including spontaneous abortion, neonatal death, and congenital abnormalities) was similar among women using low-dose budesonide or placebo throughout pregnancy.

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    This study was funded by AstraZeneca R&D, Lund, Sweden.

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