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

Abstract

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. 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 beta-agonist treatment); 104 patients agreed to participate. At ED discharge, all patients were given prednisone 40 mg/d for 5 days and inhaled beta-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. 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. 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.