EXTENDED-RELEASE ALBUTEROL IN THE TREATMENT OF 6 TO 12-YEAR-OLD ASTHMATIC-CHILDREN

Background: Albuterol sulfate, in the syrup and tablet form for oral a dministration, has been an effective treatment for adults and children with bronchial asthma. Extended-release albuterol sulfate tablets (Pr oventil Repetabs, Schering Corp.) provide a convenient, twice-daily do sing regimen, but are indicated only for patients greater than or equa l to 12 years of age. Objective: This study was undertaken to determin e whether patients 6 to 12 years of age could be effectively and safel y treated with extended-release albuterol tablets. Methods: This was a randomized, double-blind, placebo-controlled, parallel group study of 157 patients in five centers. Patients were randomized to 4 weeks' tr eatment with extended-release albuterol tablets, 4 mg twice daily (q 1 2h), increasing up to 12 mg q 12h, or placebo. Efficacy was evaluated based on pulmonary function tests (PFTs), physician and patient evalua tions, and data collected from patients' diaries on PEFR, asthma sympt oms, number of nighttime awakenings, and number of tablets taken. The primary efficacy parameter was area under the curve (AUG) for FEV(1), evaluated for 8 to 12 hours post-dosing. Safety was evaluated based on vital signs, electrocardiograms, and adverse events.Results: Mean AUC s for FEV(1) were significantly greater in the albuterol group at days 1 and 8 (P less than or equal to .03). The albuterol group showed con sistently lower severity scores for asthma symptoms. Physicians' and p atients' global evaluations favored the albuterol group over the place bo group. No serious, treatment-related adverse events were reported. There were no clinically meaningful changes from baseline in either tr eatment group for vital signs or electrocardiograms. Conclusions: Exte nded-release albuterol tablets (4 mg), administered to children 6 to 1 2 years old in divided doses of up to 24 mg/day, improved pulmonary fu nction and asthmatic symptoms and were well tolerated.