Growth, systemic safety, and efficacy during 1 year of asthma treatment with different beclomethasone dipropionate formulations: an open-label, randomized comparison of extrafine and conventional aerosols in children.

Author(s): Pedersen S, Warner J, Wahn U, Staab D, Le Bourgeois M, Van Essen-Zandvliet E, Arora S, Szefler SJ, Pediatric Study Group

Affiliation(s): Paediatrisk Afdeling, Kolding Sygehus, Kolding, Denmark. spconsult@post1.tele.dk

Publication date & source: 2002-06, Pediatrics., 109(6):e92.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

OBJECTIVE: To assess the long-term safety of hydrofluoroalkane 134a (HFA)-beclomethasone dipropionate (BDP) extrafine aerosol administered by the Autohaler compared with chlorofluorocarbon (CFC)-BDP administered by a press-and-breathe metered-dose inhaler (pMDI) and spacer (+S) in the treatment of children with asthma. METHODS: This 12-month, open-label, randomized, multicenter study enrolled 300 children who were aged 5 to 11 years and had well-controlled asthma on inhaled CFC-BDP or budesonide; 256 patients were using doses within the recommended range (200-400 microg) and were analyzed separately. Patients were randomized in a 1:3 ratio to continue on CFC-BDP+S at approximately the same dose as they were using before study entry or switch to HFA-BDP at half the daily dose. RESULTS: Asthma control was well maintained in the HFA-BDP group as evidenced by lung function tests and asthma symptoms compared with CFC-BDP+S at approximately twice the dose. There were no significant differences between the HFA-BDP 100 to 200 microg and CFC-BDP+S 200 to 400 microg treatment groups in mean change from baseline in height (5.23 cm vs 5.66 cm at month 12, respectively) or mean growth velocity from day 1 to month 12 (5.27 cm/y vs 5.71 cm/y, respectively). There were no significant differences between groups in adrenal function tests or markers of bone metabolism. CONCLUSIONS: In this long-term study in children with asthma, extrafine HFA-BDP provided long-term maintenance of asthma control at approximately half the dose compared with CFC-BDP+S. There were no clinically meaningful differences between HFA-BDP extrafine aerosol and conventional CFC-BDP+S with regard to growth or other systemic effects.