Purpose of the Study
The purpose of the study was to assess the effect of treatment with fluticasone propionate (FP) on functional status and sleep disturbances in children and to evaluate possible changes in the quality of life of the parents of these children.
There was a placebo group of 106 children, average age 8.5 years; a group treated with 50 μg of FP bid numbering 111, average age 8.5 years; and a third group treated with 100 μg of FP, 108 patients, mean age of 8.2 years.
Questionnaires were completed by parents and caregivers at baseline and at weeks 24 and 52, including the functional status II-R (FS II), the sleep scale for children (SLP-C), and the 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 ttests and differences between treatment groups were analyzed using analysis of covariance.
Mean FSII and SLP-C scores improved significantly over baseline values with either of the two FP dosing schedules. They were significantly better than those in the placebo group. The FSII scores at week 52 and SLP-C scores at weeks 24 and 52 decreased significantly in the placebo group. QOL-PAC results revealed that scores in the burden scale were significantly improved in both FP groups at 24 and 52 weeks. Subjective norms in social scales improved significantly only in the 100 μg FP group at week 52.
The authors claim that the results of this study demonstrate that either dose of FP was associated with significant improvements in functional status and decreased sleep disturbances in children with asthma. In addition, treatment with children with FP was associated with a decreased burden on the parents of these children with asthma. The authors state that the patients selected had mild to moderate daily asthma and that in general because of the patients increased quality of life, the quality of life of the caregivers also improved.
The findings of this study are not particularly surprising. One would expect that with meaningful doses of inhaled corticosteroids, regardless of which product, that a patient with mild to moderate persistent asthma would have decreased symptoms and improved quality of life. It is also not surprising that the perception of the caregiver of their quality of life would be markedly improved. The fact that the patients felt less tired with less interference of sleep and therefore less interference of the parents' sleep would all be expected in any patient and their family in which better asthma control has been achieved. Perhaps the most significant aspect of this article is the relatively low dose of inhaled corticosteroids that were used. It has become abundantly clear that the different inhaled corticosteroid products have different potencies. Reviewing the National Institutes of Health (NIH) guidelines produced in 1997 of the common products available in the United States, FP appears to be the most potent. Preliminary long-term studies would suggest that with a dose of 50 μg bid over a period of 6 months there is no inhibition of growth and that there is only minimal and probably not significant inhibition of growth at 100 μg bid. Furthermore, preliminary Canadian data suggests that this relatively long-acting inhaled corticosteroid could be used on a qd basis. This would make this medication convenient and less expensive, complementing the obvious effectiveness demonstrated in this and other studies. This is not to suggest that this product is necessarily better than the other inhaled corticosteroids but that it may be more convenient because of its potency and duration of action.