The effect of fluticasone propionate on functional status and sleep in children with asthma and on the quality of life of their parents☆,☆☆,★,★★
Section snippets
Patients
Boys between 4 and 11 years of age and girls between 4 and 9 years of age (i.e., premenarchal) with mild-to-moderate asthma (meeting the diagnostic criteria of the American Thoracic Society8) were eligible for enrollment. At study entry, each child had an FEV1 of at least 60% of the predicted normal value for the child’s age, height, and sex. Patients had been treated with inhaled corticosteroids, β2-agonists, or both for the previous month.
Study design
Health outcomes assessments were conducted as part of
RESULTS
Of the 325 patients enrolled in the study, 263 completed the study. The majority of patients discontinued because of lack of efficacy (50 μg FP group, 4; 100 μg FP group, 4; placebo: 20) or protocol violations. A total of 321 respondents completed questionnaires at baseline (104, 110, and 107 in the placebo, 50 μg FP, and 100 μg FP groups, respectively). There were no significant differences among treatment groups with respect to baseline characteristics (Table I).
DISCUSSION
The health status of children with asthma in this study was assessed with two valid and reliable instruments, the FSII, which measures functional status, and the SLP-C, which measures the occurrence of sleep disturbances and the subsequent effect on normal daily activities. On the basis of previous studies of the effectiveness of fluticasone propionate in adults,14, 15 we hypothesized that asthma would be better controlled in children who received FP than in those who received placebo (plus
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Cited by (0)
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From aGlaxo Wellcome, Global Health Outcomes, Research Triangle Park; and bColorado Allergy and Asthma Clinic, Aurora.
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Supported by Glaxo Wellcome Inc.
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Reprint requests: Puneet Mahajan, PhD, Global Health Outcomes, Glaxo Wellcome, P.O. Box 13398, Research Triangle Park, NC 27709-3398.
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