Randomized trial of inhaled flunisolide versus placebo among asthmatic patients discharged from the emergency department

Study objective: Inhaled corticosteroids (ICs) improve airflow and decrease symptoms in patients with chronic asthma. We examined whether high-dose inhaled flunisolide would have similar benefits after an emergency department visit for acute asthma. Methods: Over a 16-month period at one inner-city ED, we documented 551 eligible patients (acute asthma; age 18 to 50 years; no ICs in past week; no oral corticosteroids in past month; and peak expiratory flow rate [PEFR] <70% of predicted value after first β-agonist treatment); 104 patients agreed to participate. At ED discharge, all patients were given prednisone 40 mg/d for 5 days and inhaled β-agonists as needed and were randomly assigned to receive high-dose inhaled flunisolide 2 mg/d (n=51) or placebo (n=53). Patients were telephoned daily and asked to return for PEFR measurement at 3, 7, 12, 21, and 24 days. Results: Despite precautions, 28% (16 receiving flunisolide and 13 receiving placebo) of patients were completely lost to follow-up, 2 patients had only one follow-up (day 3), 2 patients receiving flunisolide withdrew because of medication-related bronchospasm, and 4 patients in each group experienced relapse. Among the 63 remaining patients, we found no difference between flunisolide and placebo at day 24 follow-up in percent predicted PEFR (87% versus 83% on day 24, P=.36; difference 4%, 95% confidence interval [CI] -5% to 13%). Nocturnal wheezing and nocturnal albuterol inhaler use was higher among patients receiving flunisolide than those receiving placebo on day 24 (48% versus 18% for nocturnal wheezing, P=.01; mean difference 30%, 95% CI 11% to 49%; 3.8 versus 1.4 nocturnal albuterol puffs, P=.03; mean difference 2.4 puffs, (95% CI 0.2 to 4). Levels of dyspnea, cough, and overall well-being were similar between the flunisolide and placebo groups. Conclusion: Addition of high-dose inhaled flunisolide to standard therapy does not benefit inner-city patients with acute asthma in the first 24 days after ED discharge. Airway inflammation during acute asthma may require higher doses or more potent anti-inflammatory agents.