THE EFFECT OF FLUTICASONE PROPIONATE ON FUNCTIONAL STATUS AND SLEEP IN CHILDREN WITH ASTHMA AND ON THE QUALITY-OF-LIFE OF THEIR PARENTS

Background: Although in the past drug interventions were measured prim arily on the basis of their efficacy and safety, today we are increasi ngly interested in what impact treatments have on the patient's day-to -day activities and quality of life, Objectives: We sought to assess t he effect of treatment with fluticasone propionate (FP) on functional status and sleep disturbances in children with asthma and to evaluate possible changes in the quality of life of the parents of these childr en after treatment. Methods: As part of a randomized, double-blind, pa rallel-group, placebo-controlled, multicenter study on the effects of FP powder (50 or 100 mu g twice daily) on growth in children aged 4 to 11 years with mild-to-moderate asthma (n = 325), parents/caregivers c ompleted the following questionnaires at baseline and at weeks 24 and 52 of treatment: Functional Status IIR (FSII), Sleep Scale-Children (S LP-C), and Quality of Life of Parents of Asthmatic Children (QOL-PAC), Change from baseline to weeks 24 and 52 within each treatment group w as analyzed by using paired t tests, and differences between treatment groups were analyzed by using analysis of covariance, Results: Mean F SII and SLP-C scores improved significantly over baseline values with either 50 or 100 mu g FP at weeks 23 and 52 (p < 0.05) and were signif icantly better than scores in the placebo group (p < 0,05), In contras t, FSII scores at week 52 and SLP-C scores at weeks 23 and 52 decrease d significantly in the placebo group (p < 0.05), QOL-PAC results revea led that scores on the Burden scale were significantly improved in bot h FP groups at weeks 24 and 52, Subjective Norms and Social scales imp roved significantly only in the 100 mu g FP group at week 52, Conclusi ons: The results of this study show that FP (either 50 or 100 mu g twi ce a day) was associated with significant improvements in functional s tatus and decreased sleep disturbances in children with asthma, In add ition, treatment of children with FP was associated with a decreased b urden on the parents of these children with asthma.