Outcome of pregnancy in a randomized controlled study of patients with asthma exposed to budesonide
Author
dc.contributor.author
Silverman, Michael
Author
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Sheffer, Albert
Author
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Diaz, Patricia V.
Author
dc.contributor.author
Lindmark, Bertil
Author
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Radner, Finn
Author
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Broddene, Maria
Author
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Gerhardsson De Verdier, Maria
Author
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Pedersen, Søren
Author
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Pauwels, Romain A.
Admission date
dc.date.accessioned
2019-01-29T17:57:06Z
Available date
dc.date.available
2019-01-29T17:57:06Z
Publication date
dc.date.issued
2005
Cita de ítem
dc.identifier.citation
Annals of Allergy, Asthma and Immunology, Volumen 95, Issue 6, 2018, Pages 566-570
Identifier
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10811206
Identifier
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10.1016/S1081-1206(10)61020-4
Identifier
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https://repositorio.uchile.cl/handle/2250/163931
Abstract
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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
Lenguage
dc.language.iso
en
Publisher
dc.publisher
American College of Allergy, Asthma and Immunology