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| |  ACAAI: New Inhaler Matches Conventional Beclomethasone Safety Profile By Ed Susman Special to DG News ORLANDO, FL -- November 18, 2001 -- The new hydrofluoroalkane inhaler dispensing beclomethasone dipropionate appears to have similar safety attributes to those of the conventional chlorofluorocarbon inhaler in a long-term study of childhood asthma. "The new inhaler works as well, if not better, at a lower dose," said David Donnell, Pharm D, a researcher for 3M Pharmaceuticals, of Southampton, United Kingdom, at the annual meeting of the American College of Allergy, Asthma and Immunology, held in Orlando, Florida, Nov. 16-20, 2001. Researchers recruited 247 boys and girls aged five to 11 into a 12-month, open-label, parallel group study conducted in 56 sites in Australia, Europe and the United States. Dr. Donnell said the new hydrofluoroalkane dispenser delivered about half the dose of an extrafine formulation of beclomethasone with similar rate of asthma exacerbations and adverse events when compared to the chlorofluorocarbon dispensers. The researchers noted that 10 patients in the hydrofluoroalkane group developed bronchitis during the course of the study, but no one in the other group developed that condition. None of the bronchitis cases were considered severe, nor were they deemed attributable to the medication. About 10 percent of the 183 patients on the new device dropped out of the study, about 12 percent of the 64 children on the older device left the study. The researchers also scrutinized growth rates of the children and found there were no significant differences between the old and new formulations of the inhaler. Over the 12-month period the children using the new inhaler gained 5.33 cm in height compared to 5.09 cm gained by the children on the old formulation. Dr. Donnell said that increases in height in the two treatment groups were similar to expected growth. Similarly, during the course of the study, there were no significant differences in bone markers, in 12-hour urinary-free cortisol, or response to low-dose adrenocorticotrophic hormone stimulation between the two groups. The researchers said the study was performed to determine if the new inhaler worked in children as successfully as it worked in previous studies in an adult population.
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