Background: Although in the past drug interventions were measured primarily on the basis of their efficacy and safety, today we are increasingly interested in what impact treatments have on the patient's day-to-day activities and quality of life.
Objectives: We sought to assess the 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 children after treatment.
Methods: As part of a randomized, double-blind, parallel-group, placebo-controlled, multicenter study on the effects of FP powder (50 or 100 microg twice daily) on growth in children aged 4 to 11 years with mild-to-moderate asthma (n = 325), parents/caregivers completed the following questionnaires at baseline and at weeks 24 and 52 of treatment: Functional Status IIR (FSII), Sleep Scale-Children (SLP-C), and Quality of Life of Parents of Asthmatic Children (QOL-PAC). Change from baseline to weeks 24 and 52 within each treatment group was analyzed by using paired t-tests, and differences between treatment groups were analyzed by using analysis of covariance.
Results: Mean FSII and SLP-C scores improved significantly over baseline values with either 50 or 100 microg FP at weeks 24 and 52 (p < 0.05) and were significantly better than scores in the placebo group (p < 0.05). In contrast, FSII scores at week 52 and SLP-C scores at weeks 24 and 52 decreased significantly in the placebo group (p < 0.05). QOL-PAC results revealed that scores on the Burden scale were significantly improved in both FP groups at weeks 24 and 52. Subjective Norms and Social scales improved significantly only in the 100 microg FP group at week 52.
Conclusions: The results of this study show that FP (either 50 or 100 microg twice a day) was associated with significant improvements in functional status and decreased sleep disturbances in children with asthma. In addition, treatment of children with FP was associated with a decreased burden on the parents of these children with asthma.