Study objective: To determine the effect of adding the nebulized antic
holinergic drug ipratropium bromide to standard therapy compared with
standard therapy alone for acute severe asthma (peak expiratory flow r
ate [PEFR] <50% of predicted) in children presenting to the emergency
department. Methods: Ninety children aged 6 to 18 years were randomly
assigned to two groups in a prospective, double-blind, placebo-control
led study performed in the ED of an urban children's hospital. All chi
ldren received nebulized albuterol solution (.15 mg/kg) every 30 minut
es, and all received oral steroids with the second dose of albuterol.
Children in group 1 received ipratropium bromide (500 mu g/dose) with
the first and third dose of albuterol; those in group 2 received salin
e placebo instead of ipratropium. Pulmonary functions (PEFR and 1-seco
nd forced expiratory volume [FEV(1)]) and physiologic measurements wer
e assessed every 30 minutes up to 120 minutes. By chance, the baseline
values for percent of predicted PEFR and FEV(1) differed between the
two groups. Therefore a multivariate model accounting for both time an
d baseline effects was used to compare the response between groups. Re
sults: On average, and adjusting for baseline measures, children in th
e ipratropium group had a significantly greater improvement in percent
of predicted PEFR than did children in the placebo group at 60 minute
s (P=.02), 90 minutes (P=.002), and 120 minutes (P<.0001). The improve
ment in percent predicted FEV(1) was significantly greater for childre
n in the ipratropium group only at 120 minutes (P=.013). Nine children
(20%) from the ipratropium group and 14 (31.1%) from the control grou
p were admitted (P=.33, chi(2)). There were no significant adverse eff
ects attributable to the ipratropium, and there was no relation betwee
n ipratropium use and changes in pulse, respiratory rate, blood pressu
re, or oxygen saturation. Conclusion: We detected significant improvem
ent in pulmonary function studies over 120 minutes in children with se
vere asthma who were given nebulized ipratropium combined with albuter
ol and oral steroids, compared with children who received the standard
therapy Further study is needed to determine whether early use of ipr
atropium decreases the need for hospitalization.