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PEDIATRICS Vol. 109 No. 6 June 2002, pp. e92

ELECTRONIC ARTICLE

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

Søren Pedersen, MD*, John Warner, MD{ddagger}, Ulrich Wahn, MD§, Doris Staab, MD§, Muriel Le Bourgeois, MD||, Elisabeth Van Essen-Zandvliet, MD, Sujata Arora, MS** and Stanley J. Szefler, MD{ddagger}{ddagger} on behalf of the Pediatric Study Group

* Paediatrisk Afdeling, Kolding Sygehus, Kolding, Denmark
{ddagger} Department of Child Health, Southampton General Hospital, Southampton, United Kingdom
§ Department of Pediatric Pneumology and Immunology, Charité, Humboldt-University, Berlin, Germany
|| Service de Pneumologie et D’Allergologie Pediatriques, Groupe Hopitalier Necker Enfants Malades, Paris, France
Asthma Center Heideheuvel, Hilversum, the Netherlands
** 3M Pharmaceuticals, St Paul, Minnesota
{ddagger}{ddagger} National Jewish Medical and Research Center, Denver, Colorado

--> 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 µg) 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 µg and CFC-BDP+S 200 to 400 µg 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.

Key Words: children • asthma • inhaled corticosteroid • CFC-free • hydrofluoroalkane-134a beclomethasone dipropionate • growth

Abbreviations: BDP, beclomethasone dipropionate • CFC, chlorofluorocarbon • HFA, hydrofluoroalkane • pMDI, press-and-breath metered-dose inhaler • +S, plus spacer • FEV1, forced expiratory volume in 1 second • PEF, peak expiratory flow • PICP, carboxy propeptide of procollagen type 1 • 1-CTP, 1-collagen telopeptide • ACTH, adrenocorticotrophic hormone • UFC, urinary free cortisol • EPX, eosinophilic protein X • CI, confidence interval

Received for publication Oct 26, 2001; Accepted Feb 15, 2002.




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