Pneumonia or an elevated temperature (ie > 38.9°C)

Materials and Methods This trial was conducted in 20 US hospital-affiliated EDs. Patients aged 12 to 65 years who presented to the ED with acute asthma were screened by study investigators for trial eligibility. Eligible patients were those with a history of asthma and a FEV₁ of < 70% predicted both at ED entry and 25 min after receiving a single aerosol treatment with 2.5 mg of albuterol. Patients with the following conditions were excluded from the study: history of smoking of > 10 pack-years.

Positive pregnancy test result; a recent history of oral corticosteroid use (ie, > 5 days) or treatment with a leukotriene-modifying drug within 2 weeks of ED entry; a need for intubation before randomization; pneumonia or an elevated temperature (ie, > 38.9°C); chronic lung disease other than asthma; or diabetes mellitus or any other clinically significant medical condition that could affect the required evaluations. 

Additionally, patients had to be willing to stay in the ED for at least 4 h (ie, the ED period) and then to participate in a 28-day outpatient treatment program (Fig 1). The trial was conducted in compliance with the principles of good clinical practice, approval was obtained from each institutional review board, and informed consent was obtained from all patients. 

Trial Design and Treatment At ED entry, patients underwent spirometry and were treated with nebulized albuterol (2.5-mg unit-dose nebules) [Ventolin; GlaxoSmithKline; Research Triangle Park, NC]. Spirometry was repeated 25 min after ED entry, and patients with FEV₁ values still < 70% of predicted were randomized, 1:1:2, respectively, to double-blind, single-dose treatment with zafirlukast, 160 mg (Z160), zafirlukast, 20 mg (Z20) [Accolate; AstraZeneca; Wilmington, DE], or matching placebo. Patients then received a 60-mg po dose of prednisone and a second dose of nebulized albuterol, with additional albuterol administered at 60, 120, and 180 min after ED entry.

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