RT Journal
A1 Rowe BH, Bota GW, Fabris L, Therrien SA, Milner RA, Jacono J
T1 Inhaled budesonide in addition to oral corticosteroids to prevent asthma relapse following discharge from the emergency department: A randomized controlled trial
JF JAMA
JO JAMA
YR 1999
FD June 9
VO 281
IS 22
SP 2119
OP 2126
DO 10.1001/jama.281.22.2119
UL http://dx.doi.org/10.1001/jama.281.22.2119
AB Context 
                  Relapses of acute asthma following emergency
department (ED) discharge can be reduced with systemic corticosteroid
treatment. However, whether inhaled corticosteroids (ICSs) provide
additional benefit is not known.Objective 
                  To determine whether the addition of ICSs to oral
corticosteroid treatment would reduce relapses in patients with acute
asthma discharged from the ED.Design and Setting 
                  Placebo-controlled, double-blind, randomized
clinical trial conducted in a community teaching hospital ED in Canada
between November 1995 and September 1997, with a 21-day follow-up.Participants 
                  A total of 1006 consecutive patients aged 16 to 60
years presented to the ED with acute asthma; after excluding those
using oral and/or inhaled corticosteroids as well as those meeting
other exclusion criteria, 188 were included in the study.Interventions 
                  Patients were discharged with a nontapering course
of oral prednisone (50 mg/d) for 7 days. In a double-blind fashion,
patients were randomly assigned to 1600 µg/d of inhaled budesonide
(n=94) or identical placebo (n=94) for
21 days.Main Outcome Measures 
                  Incidence of relapse, defined as an
unscheduled visit for worsening asthma symptoms, in budesonide vs
placebo groups. Secondary outcomes included response to the Asthma
Quality of Life Questionnaire, β2-agonist use, symptom
score, global asthma improvement assessment, and pulmonary function.Results 
                  Five patients in the budesonide group and 3 in the placebo
group either dropped out or were lost to follow-up but were included in
primary analyses. After 21 days, 12 (12.8%) of 94 patients in the
budesonide group experienced a relapse compared with 23 (24.5%) of 94
in the placebo group, a 48% relapse reduction
(P=.049). Asthma Quality of Life Questionnaire
scores were higher (better quality) in the budesonide group
(P=.001), as well as for all domain scores
(P=.001 to .01). Fewer
β2-agonist activations were used at the end of the trial
by patients receiving budesonide (2.4/d vs 4.2/d;
P=.01). Symptom scores
(P=.001 to .004) and self-assessed asthma
improvement scores (based on a 7-point Likert scale) (6.2 vs 5.2;
P<.001) were higher (indicating fewer symptoms) for
budesonide vs placebo. There were no differences in pulmonary function
between the groups (peak expiratory flow rate: budesonide, 437 vs
placebo, 453 L/min; P=.39) at 21 days. Using
this approach, as few as 9 patients would require budesonide to prevent
1 relapse.Conclusions 
                  Patients discharged from the ED following treatment
for acute asthma benefit from added treatment with high-dose inhaled
budesonide for 21 days compared with oral corticosteroids
alone.