NEW ORLEANS (Reuters Health) - In a study lasting 1 year, flunisolide hydrofluoroalkane (HFA), a new inhaled corticosteroid formulation, had no effect on height or growth velocity in pre-adolescences with mild asthma, according to a presentation by Dr. Leon S. Greos to the American College of Allergy, Asthma and Immunology.
Flunisolide HFA (Aerospan; Forest Laboratories) has an extra-fine particle size and built-in spacer that results in improved lung deposition compared with flunisolide chlorofluorocarbon (CFC) (68.3% vs 19.7%) with a concomitant reduction in oropharyngeal deposition (25.0% vs 79.9%), Dr. Greos explained.
“Because the propellant has changed and the drug gets deposited deeper into the lung, we have to address important questions--one of the most important in the pediatric population being the effects on growth,” he added.
In the study, 242 children aged 4 to 9.5 years with mild asthma (percent of predicted FEV1 > 75%) were randomized to flunisolide HFA 85 micrograms twice daily (2 puffs) or placebo. One hundred sixty-three patients completed the study.
After 1 year, there were no statistically significant differences in growth velocity, height attainment or bone maturation between the placebo and active treatment groups. “This is important,” Dr. Greos noted, “because numerous studies of inhaled corticosteroids have uniformly shown growth suppression in children studied over 1 year.”
Dr. Greos, who is with the Colorado Allergy and Asthma Centers in Englewood, said flunisolide HFA is currently “in the approval process” at the U.S. Food and Drug Administration. “We are bringing an old drug into a new propellant with new delivery technology, so as far as the FDA is concerned this is a new drug.”
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