Efficacy and safety of high-dose inhaled steroids in children with asthma: A comparison of fluticasone propionate with budesonide☆,☆☆

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Abstract

Objective: To compare the efficacy and adverse effects of inhaled fluticasone propionate (FP), 400 μg/d, with those of budesonide (BUD), 800 μg/d, in children with moderate to severe asthma. Methods: Three hundred thirty-three children, ages 4 to 12 years, receiving inhaled corticosteroids were enrolled in a double-blind, double-dummy, randomized, parallel-group study. After a 2-week run-in phase, 166 children received FP and 167 received BUD for 20 weeks. The primary outcome variable was mean morning peak expiratory flow; the 2 treatments were to be regarded as equivalent if the 90% CI for the treatment difference was within ± 15 L/min. Pulmonary function, height, and diary cards were assessed at each visit; and morning serum cortisol levels were determined before and after treatment. Results: Baseline peak expiratory flow was similar, FP 236 ± 72 (SD) L/min and BUD 229 ± 74, increasing after treatment to 277 ± 41 and 257 ± 28, a difference between treatments of 12 L/min (90% CI 6-19 L/min; P = .002). Symptom control and use of rescue medication were the same. Cortisol levels after treatment were 199 nmol/L (FP) and 183 nmol/L (BUD) (treatment ratio = 1.09; 90% CI 0.98-1.21; P = .172). Linear growth was less in those receiving BUD (mean difference, 6.2 mm; 95% CI 2.9-9.6; P = .0003). Conclusion: FP at half the dose was superior to BUD in improving peak expiratory flow and comparable in controlling symptoms. Growth was reduced with BUD compared with FP, but there was no difference in serum cortisol suppression or hepatic or renal function. (J Pediatr 1999;134:422-7)

Section snippets

METHODS

A cohort of 442 children, ages 4 to 12 years, with a history of moderate to severe asthma were recruited from 6 countries. All had a Sexual Maturity Rating of 1 (prepubertal) at the time of the initial clinic visit. Children with only seasonal or exercise-induced symptoms were excluded. All subjects required moderate to high doses of ICS to control symptoms, 400 to 800 μg of BDP or BUD or 200 to 400 μg of FP per day for at least 1 month preceding the start of the run-in period. All were using

RESULTS

A total of 442 children were enrolled in the study, of whom 333 proceeded to randomized treatment and qualified for the primary population of analysis, the intent-to-treat population. There were 166 subjects who received FP, 200 μg twice daily, and 167 subjects who received BUD, 400 μg twice daily. Twenty-five subjects (7.5%) were ultimately excluded from analysis because of protocol violations (15 receiving FP and 10 receiving BUD); protocol violations were incorrect dose of ICS or inadequate

DISCUSSION

The results of our study are consistent with previous reports of similar clinical efficacy when comparing FP (200 μg) and BDP (400 μg) per day in children with mild to moderate asthma2, 3 and when comparing FP at half the daily dose with BUD in adult asthmatic subjects.4, 5, 6, 7 A study in children with mild to moderate asthma, in which FP and BUD (both 400 μg/d) were compared, showed a similar effect in control of asthma symptoms.8 Our findings of equivalence or superior clinical effect with

Acknowledgements

The following physicians kindly allowed their patients to participate in this study. Canada: B. Lyttle, P. Patel, S. Mehra, P. Zuberbuhler, D. Hughes, B. Muram, D. Hummel, L. Charette, J. Bouchard, D. Wong, W. Arkinstall, and T. Kovesi. Denmark: K. Ibsen and J. Henricksen. Finland: A. Koivikki. Netherlands: J. Pilon, J. Hoekx, W. den Ouden, R. Roorda, and J. Gosen. Indonesia: N. Rahayoe. Poland: J. Pietrzyk, A. Emeryk, and T. Malaczynska. South Africa: G. Brereton-Stiles, M. Ossip, M. Laher,

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Reprint requests: Alexander C. Ferguson, MD, University of British Columbia, B.C. Children’s Hospital, 4480 Oak St, Vancouver, BC, V6H 3V4, Canada.

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