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Royal Alexandra
Hospital for Children, P O Box 3515, Parramatta, Sydney, New South
Wales, Australia 2124
Correspondence to: Dr D Fitzgerald, Department of Paediatrics, John Hunter Children's Hospital, Locked Bag No. 1, Newcastle Mail Centre, Newcastle, New South Wales, Australia 2310.
Received 24 September 1997; Returned to authors 12 December 1997; Revised version received 10 March 1998; Accepted for publication 8 April 1998
BACKGROUND
Previous
studies have suggested a 2:1 efficacy advantage of fluticasone
propionate (FP) over beclomethasone dipropionate (BDP) in adults on
high dose inhaled steroids and children on low dose inhaled steroids.
The lower doses of FP required to provide equivalent efficacy to BDP
also appear to have fewer systemic effects as measured by adrenal function.
METHODSThe efficacy
and safety of FP 750 µg/day and BDP 1500 µg/day were compared in 30 children with persistent asthma (requiring 1000-2000 µg/day of
inhaled corticosteroids) in a 12 week randomised double blind crossover
study. Medication was delivered by a spacer device in two divided
doses. Primary efficacy variables were peak expiratory flows (PEF).
Adrenal function was assessed by 24 hour urinary free cortisol levels
at eight and 12 weeks and ACTH and low dose synacthen tests (LDST) at
12 weeks. The results were adjusted for sequence and period differences.
RESULTSThere was no
difference in the primary efficacy variables over the two 12 week
treatment periods (difference in adjusted means for morning PEF 1.3 l/min (95% CI -6.1 to 8.8), p = 0.112) and symptom scores (cough,
tachypnoea, wheeze, shortness of breath; difference in adjusted means
of night time scores: -0.06 (95% CI -0.14 to 0.03); p = 0.136).
Similar degrees of mild adrenal dysfunction were found during BDP and
FP treatment phases. Identical height gain velocities were shown during
the corresponding periods.
CONCLUSIONSFP 750 µg/day is as effective as BDP 1500 µg/day in children with
persistent asthma. At these very high doses we were unable to
demonstrate a safety advantage of FP over BDP as assessed by adrenal
function. However, measures of adrenal function may have been
influenced by concurrent and previous systemic steroid usage, and
possibly by effects of disease activity.
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