PEDIATRIC PHARMACOLOGY AND THERAPEUTICS Efficacy of frequent ipratropium bromide added high-dose albuterol therapy childhood asthma nebulized to frequent in severe

Objective: The object ive of this trial was to determine the ef f icacy of frequent nebul ized ipratropium added to high-dose albuterol therapy in chi ldren with severe asthma. Methods: One hundred twenty chi ldren (5 to 17 years) of age) with severe acute asthma ( forced expiratory volume in I second [FEV1], <50% of the predicted value) were enrol led into a randomized double-b l ind three-arm p lacebo-control led trial compar ing three groups: group I, three doses of nebul ized ipratropium bromide within 60 minutes (250/~g/dose); group 2, one dose of ipratropium; group 3, no ipratropium. All patients were also treated with three doses of nebulized albuterol within 60 minutes (0.15 mg/kg per dose). Pulmonary funct ion and cl in ical measures were assessed every 20 minutes for up to 120 minutes. Results: The groups were corn parable at baseline. At 120 minutes, the mean percen tage of pred ic ted FEV1 improved from 33.4% to 56.7% in group I, from 34.2% to 52.3% in group 2, and from 35.4% to 48.4% in group 3 (p = 0.0001). The differences between groups were larger in those chi ldren with a basel ine FEV4 __<30% of the predic ted value: FEV1 increased from 24.5% to 50.9% in group 1, from 25.0% to 39.8% in group 2, and from 25.9% to 36.5% in group 3 (p =0.0001). In group I, 38% of the patients were hospital ized after the study, 44% in group 2, and 46% in group 3 (p value not signif icant). However, in patients with FEV~ ~30%, the hospital ization rates were 27% in group 1, 56% in group 2, and 83% in group 3 (p = 0.027). There were no tox ic effects at tr ibutable to ipratropium. Conclusion: The addi t ion of repeated doses of nebul ized ipratropium to frequent high-dose albuterol therapy in patients with acute severe asthma is both safe and more ef fect ive than albuterol a lone; its use in patients with very severe asthma may reduce hospitalizations. (J PEDIATR 1995;126:639"45)