Randomized trial of inhaled flunisolide versus placebo in asthmatics discharged from the emergency department

Purpose: Inhaled corticosteroids improve airflow and decrease symptoms in patients with chronic asthma. This trial examined if inhaled flunisolide would improve airflow and asthma symptoms after an emergency department (ED) visit for acute asthma. Methods: Over a 16-month period, we documented approximately 1,939 ED asthma visits to an inner city teaching hospital. On-site research associates ensured compliance with national asthma guidelines. Approximately 610 patients were eligible for the trial (age 18-50; no use of inhaled corticosteroids or theophylline in past week; no oral corticosteroids in past month; peak expiratory flow rate [PEFR] < 70% after first β-agonist treatment), of which 104 agreed to participate. At discharge from the ED, all subjects were given prednisone 40 mg/d for 5 days and inhaled -agonist as needed. Subjects were randomized to inhaled flunisolide 2 mg per day (F, n=51) or inhaled placebo (P, n=53). All patients were telephoned daily and returned for PEFR measurements and symptom inventories at 3, 7, 12, 21, and 24 days. Data were analyzed using t-test and Fisher's exact test. Results: 28% of patients were completely lost to follow-up (16 F, 13 P). Two F patients withdrew within 7 days due to coughing, and 4 patients relapsed in each group. There were no significant differences between F vs. P at baseline, or at any follow-up day, for % of predicted or best PEFR (84% vs. 84% on day 24, p=0.97), number of inhalant uses, cough, dyspnea, and overall well-being. Nocturnal wheezing was higher among F patients on day 24 (46% vs. 13%; p=0.01). Conclusions: Addition of high-dose inhaled flunisolide to standard therapy does not benefit asthmatics in the first 24 days after ED discharge. Clinical Implications: Concerns about post-ED medication compliance appear justified, since high-dose inhaled flunisolide appears ineffective among patients expected to obtain benefit.