Document Detail

Outcome of pregnancy in a randomized controlled study of patients with asthma exposed to budesonide.
MedLine Citation:
PMID:  16400897     Owner:  NLM     Status:  MEDLINE    
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.
Michael Silverman; Albert Sheffer; Patricia V Diaz; Bertil Lindmark; Finn Radner; Maria Broddene; Maria Gerhardsson de Verdier; Søren Pedersen; Romain A Pauwels;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology     Volume:  95     ISSN:  1081-1206     ISO Abbreviation:  Ann. Allergy Asthma Immunol.     Publication Date:  2005 Dec 
Date Detail:
Created Date:  2006-01-10     Completed Date:  2006-01-26     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9503580     Medline TA:  Ann Allergy Asthma Immunol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  566-70     Citation Subset:  IM    
Division of Child Health, University of Leicester, Leicester, England.
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MeSH Terms
Abortion, Spontaneous* / epidemiology
Asthma / drug therapy*
Bronchodilator Agents / administration & dosage,  adverse effects*,  therapeutic use
Budesonide / administration & dosage,  adverse effects*,  therapeutic use
Child, Preschool
Congenital Abnormalities* / epidemiology
Middle Aged
Pregnancy Outcome
Reg. No./Substance:
0/Bronchodilator Agents; 51333-22-3/Budesonide

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