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Inhaled Budesonide in Addition to Oral Corticosteroids to Prevent Asthma Relapse Following Discharge From the Emergency Department
A Randomized Controlled Trial
Brian H. Rowe, MD, MSc;
Gary W. Bota, MD, FRCP;
Lucio Fabris, BScPharm;
Sandra A. Therrien, MA;
Ruth A. Milner, MA;
John Jacono, PhD
JAMA. 1999;281:2119-2126.
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,  2-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 2-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.
Author Affiliations: Division of Emergency Medicine, University of Alberta, Edmonton (Dr Rowe); Department of Emergency Medicine (Dr Bota) and Acute Care Research Group (Drs Rowe and Bota, Mr Fabris, and Ms Therrien), Sudbury Regional Hospital, Sudbury, Ontario; University of British Columbia, Vancouver (Ms Milner); and Institute of Health Care, University of Malta, G'Mangia, Malta (Dr Jacono).
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