Quality of Life in Pediatric Asthma Patients Treated with Salmeterol and Impact on the Daily Activities of Their Parents

Abstract

Measuring the impact of a disease such as asthma on a patient's health status can be an important tool in assessing the effectiveness of a new drug intervention. The objective of this study was to evaluate the effect of twice-daily salmeterol powder treatments on quality of life (specifically, functional status and sleep quality) in children with mild to moderate asthma, and to assess the impact of treatment on the daily activities of their parents/guardians. Analysis was part of a multicenter, randomized, double-blind, placebocontrolled study of 207 children aged 4 to 11 years assessing the efficacy of 50 μg salmeterol powder twice daily over 12 weeks. To measure the effect of treatment on patients' quality of life, the Functional Status II-R (FSII-R) and Sleep Scale-Children (SLP-C) questionnaires were administered to the parents/guardians at baseline and after 4,8, and 12 weeks of study. Additionally, parents/guardians completed at the same time points a questionnaire that measured the extent to which the child's asthma interfered with work and leisure activities. Mean FSII-R and SLP-C scores were significantly higher (p ≤.02) in the salmeterol group compared with the placebo group after 8 and 12 weeks of treatment. Parents/guardians of the salmeterol-treated patients reported significant declines (p ≤.04) from baseline in the extent to which their child's asthma interfered with work and leisure activities. Children with mild-to-moderate asthma treated with 50 μg salmeterol powder twice daily for 12 weeks experienced significantly better functional status and less sleep disruption compared with those treated with placebo. Additionally, the parents of the children treated with salmeterol consistently showed significant reductions in interference with work and leisure activities