title: Zafirlukast in clinical practice: results of the Accolate Clinical Experience and Pharmacoepidemiology Trial (ACCEPT) in patients with asthma.
abstract: BACKGROUND
  Zafirlukast is an oral leukotriene receptor antagonist used in the treatment of patients with mild to moderate asthma. To investigate its effects in a clinical practice setting, we evaluated zafirlukast in a heterogeneous group of patients who had asthma of different degrees of severity and who were receiving concomitant asthma medications.
  
  
  METHODS
  A total of 3759 patients were enrolled at 924 sites. Patients received zafirlukast 20 mg twice a day for 4 weeks. Pulmonary function was measured twice a day, and overall asthma symptom scores, number of nighttime awakenings, severity of morning asthma symptoms, and beta2-agonist use were recorded daily.
  
  
  RESULTS
  In the efficacy analysis (3207 evaluable patients), all parameters showed statistically significant improvement that continued throughout the 4 weeks of the trial. A total of 71% of patients had improved pulmonary function and 72% had improved asthma symptoms. Improvement was consistent regardless of asthma severity category and regardless of concomitant asthma medication category. More than 70% of both physicians and patients indicated there was clinical improvement in pulmonary measures as well as in asthma symptoms. Common adverse events reported were headache (3.7%), nausea (1.4%), pharyngitis (1.4%), and sinusitis (1.1%).
  
  
  CONCLUSIONS
  Zafirlukast 20 mg twice a day is well tolerated and improves pulmonary function and asthma symptoms, regardless of asthma severity category and regardless of concomitant asthma medication category.
authors.affiliation: Department of Pediatrics (Allergy), University of California, San Diego, USA.
authors.forename: J P
authors.initials: JP
authors.lastname: Kemp
authors.forename: P E
authors.initials: PE
authors.lastname: Korenblat
authors.forename: J E
authors.initials: JE
authors.lastname: Scherger
authors.forename: M
authors.initials: M
authors.lastname: Minkwitz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D005194:Family Practice; D005260:Female; D006801:Humans; D007211:Indoles; D020024:Leukotriene Antagonists / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008511:Medicine; D008875:Middle Aged; D048448:Phenylcarbamates; D011647:Puerto Rico; D012129:Respiratory Function Tests; D013038:Specialization; D013449:Sulfonamides; D014105:Tosyl Compounds / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D014481:United States
chemical_list: D018927:Anti-Asthmatic Agents; D007211:Indoles; D020024:Leukotriene Antagonists; D048448:Phenylcarbamates; D013449:Sulfonamides; D014105:Tosyl Compounds; C062735:zafirlukast