Outcome of pregnancy in a randomized controlled study of patients with asthma exposed to budesonide.
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, 7241 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 microg for adults. The study included 2473 females aged 15 to 50 years at randomization. Pregnancy was not an exclusion criterion (except for U.S. 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.
Silverman
Michael
M
Division of Child Health, University of Leicester, Leicester, England. ms70@le.ac.uk
Sheffer
Albert
A
Diaz
Patricia V
PV
Lindmark
Bertil
B
Radner
Finn
F
Broddene
Maria
M
de Verdier
Maria Gerhardsson
MG
Pedersen
Søren
S
Pauwels
Romain A
RA
D000022:Abortion, Spontaneous / Q000453:epidemiology; D000293:Adolescent; D000328:Adult; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D000013:Congenital Abnormalities / Q000453:epidemiology; D005260:Female; D006801:Humans; D008875:Middle Aged; D011247:Pregnancy; D011256:Pregnancy Outcome
D001993:Bronchodilator Agents; D019819:Budesonide