Effect of age on response to zafirlukast in patients with asthma in the Accolate Clinical Experience and Pharmacoepidemiology Trial (ACCEPT)

Background: The Accolate Clinical Experience and Pharmacoepidemiology Trial (ACCEPT), evaluated zafirlukast in a wide spectrum of patients from a vari ety of clinical practices. Objective: To determine the effect of age on the response to zafirlukast 20 mg twice daily in 3759 patients with mild, moderate, or severe asthma. Methods: Patients received open-label administration of zafirlukast 20 mg t wice daily (bid) for 4 weeks. Pulmonary function was measured twice daily, and overall asthma symptom scores, number of nighttime awakenings, severity of morning asthma symptoms, and beta(2)-agonist use were recorded daily. T rial results were analyzed to compare the efficacy of zafirlukast in 263 ad olescent (12 to 17 years old), 2602 adult (18 to 65 years old), and 321 eld erly (66 years old and older) patients (the evaluable population). Results: After 4 weeks of zafirlukast therapy, improvements in pulmonary fu nction decreased with age and were significant for all measures in adolesce nts and adults and for morning peak expiratory flow in elderly patients. Im provements in symptom response were statistically significant across age gr oups. Reduction in beta(2)-agonist rescue was similar in adolescents and ad ults but significantly less in elderly patients. Conclusions: Zafirlukast is an effective treatment for asthma in all patien ts, regardless of age. In elderly patients, improvement in asthma symptoms rather than pulmonary function may represent a primary marker for efficacy with zafirlukast.