The effect of fluticasone propionate on functional status and sleep in children with asthma and on the quality of life of their parents

doi:10.1016/S0091-6749(98)70050-8

Journal of Allergy and Clinical Immunology

Volume 102, Issue 1, July 1998, Pages 19-23

https://doi.org/10.1016/S0091-6749(98)70050-8 Get rights and content

Abstract

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 μg 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 μg FP at weeks 24 and 52 (p < 0.05) and were significantly better than scores in theplacebo 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 μg FP group at week 52.

Conclusions: The results of this study show that FP (either 50 or 100 μg 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. (J Allergy Clin Immunol 1998;102:19-23.)

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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^☆: From ^aGlaxo Wellcome, Global Health Outcomes, Research Triangle Park; and ^bColorado Allergy and Asthma Clinic, Aurora.

^☆☆: Supported by Glaxo Wellcome Inc.

^★: Reprint requests: Puneet Mahajan, PhD, Global Health Outcomes, Glaxo Wellcome, P.O. Box 13398, Research Triangle Park, NC 27709-3398.

^★★: 0091-6749/98 $5.00 + 0 1/1/90087

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The effect of fluticasone propionate on functional status and sleep in children with asthma and on the quality of life of their parents☆,☆☆,★,★★

Abstract

Section snippets

Patients

Study design

RESULTS

DISCUSSION

J Pediatrics

J Allergy Clin Immunol

Ann Allergy Asthma Immunol

Trends in activity-limiting chronic conditions among children

Am J Pub Health

Impact of childhood asthma on health

Pediatrics

Evaluation of the burden of illness for pediatric asthmatic patients and their families

Ann Allergy

A 1-year comparison of the effects of inhaled fluticasone propionate (FP) and placebo on growth in prepubescent children with asthma [abstract]

Eur Respir J

Parental perceptions of childhood illness

J Asthma