Fluticasone propionate compared with budesonide: a double-blind trial in asthmatic children using powder devices at a dosage of 400 microg x day(-1)

The aim of this study was to compare fluticasone propionate (FP) with budesonide (BUD) at a dose of 400 microg x day(-1) in the treatment of children with asthma. Two hundred and twenty nine children with mild-to-moderate asthma, currently receiving 200-400 microg x day(-1) of inhaled corticosteroid, were randomized to receive either 400 microg x day(-1) of FP from the Diskhaler (registered trade mark of the Glaxo Group of Companies) or 400 microg x day(-1) of BUD from the Turbuhaler (registered trade mark of Astra Pharmaceuticals Ltd) for 8 weeks, in a parallel-group, double-blind, double-dummy study. Primary efficacy was assessed by measurement of daily peak expiratory flow (PEF). In addition, pulmonary function tests were performed at each clinic visit and a self-administered patient-centred questionnaire was completed by one parent of each patient at the start and end of study treatment. Mean morning PEF increased following treatment both with FP and BUD, but was significantly higher following treatment with FP during Weeks 1-4 (p=0.015) and Weeks 1-8 (p=0.019). Similar results were found for mean evening PEF and percentage predicted morning and evening PEF. Children receiving FP experienced significantly less disruption in their physical activities (i.e. sports, games) because of their asthma compared to children treated with BUD (p=0.03). Mean cortisol levels increased in both groups, but the increase was significantly higher in the FP group at 4 weeks (p=0.022). Serum and urine markers of bone formation and resorption changed very little and showed no consistent pattern of change. Fluticasone propionate at a dosage of 400 microg x day(-1) from the Diskhaler provided a more rapid and greater improvement in lung function in children with mild-to-moderate asthma than BUD 400 microg day(-1) from the Turbuhaler. Both treatments were well-tolerated, with a similar safety profile.

This article has been cited by other articles:

				C. Roux, S. Kolta, J.-L. Desfougeres, P. Minini, and E. Bidat Long-Term Safety of Fluticasone Propionate and Nedocromil Sodium on Bone in Children With Asthma Pediatrics, June 1, 2003; 111(6): e706 - 713. [Abstract] [Full Text] [PDF]

				H.G.M. Arets, A.W.A. Kamps, H.J.L. Brackel, P.G.H. Mulder, N.A. Vermue, and C.K. van der Ent Children with mild asthma: do they benefit from inhaled corticosteroids? Eur. Respir. J., December 1, 2002; 20(6): 1470 - 1475. [Abstract] [Full Text] [PDF]

				C. S. Pao and S. A. McKenzie Randomized Controlled Trial of Fluticasone in Preschool Children with Intermittent Wheeze Am. J. Respir. Crit. Care Med., October 1, 2002; 166(7): 945 - 949. [Abstract] [Full Text]

				T C Medici, E Grebski, M Häcki, P Rüegsegger, C Maden, and J Efthimiou Effect of one year treatment with inhaled fluticasone propionate or beclomethasone dipropionate on bone density and bone metabolism: a randomised parallel group study in adult asthmatic subjects Thorax, May 1, 2000; 55(5): 375 - 382. [Abstract] [Full Text]

				S. Kannisto, M. Korppi, K. Remes, and R. Voutilainen Adrenal Suppression, Evaluated by a Low Dose Adrenocorticotropin Test, and Growth in Asthmatic Children Treated with Inhaled Steroids J. Clin. Endocrinol. Metab., February 1, 2000; 85(2): 652 - 657. [Abstract] [Full Text]

				P. J. BARNES, S. PEDERSEN, and W. W. BUSSE Efficacy and Safety of Inhaled Corticosteroids . New Developments Am. J. Respir. Crit. Care Med., March 1, 1998; 157(3): S1 - 53. [Full Text] [PDF]