Inhaled budesonide in addition to oral corticosteroids to prevent asthma relapse following discharge from the emergency department - A randomized controlled trial

Context. Relapses of acute asthma following emergency department (ED) disch arge can be reduced with systemic corticosteroid treatment. However, whethe r 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 f rom the ED. Design and Setting. Placebo-controlled, double-blind, randomized clinical t rial conducted in a community teaching hospital ED in Canada between Novemb er 1995 and September 1997, with a 21-day follow-up. Participants. A total of 1006 consecutive patients aged 16 to 60 years pres ented 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 p rednisone (50 mg/d) for 7 days. In a double-blind fashion, patients were ra ndomly assigned to 1600 mu g/d of inhaled budesonide (n = 94) or identical placebo (n = 94) for 21 days. Main Outcome Measures. Incidence of relapse, defined as an unscheduled visi t for worsening asthma symptoms, in budesonide vs placebo groups. Secondary outcomes included response to the Asthma Quality of Life Questionnaire, be ta(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 e ither dropped out or were lost to follow-up but were included in primary an alyses. After 21 days, 12 (12.8%) of 94 patients in the budesonide group ex perienced a relapse compared with 23 (24.5%) of 94 in the placebo group, a 48% relapse reduction (P = .049). Asthma Quality of Life Questionnaire scor es were higher (better quality) in the budesonide group (P = .001), as well as for all domain scores (P = .001 to .01). Fewer beta(2)-agonist activati ons 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 ex piratory flow rate: budesonide, 437 vs placebo, 453 L/min; P = .39) at 21 d ays. 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 2 1 days compared with oral corticosteroids alone.