Oral Albuterol in the Treatment of Childhood Asthma

The efficacy, safety, tolerance, and bioequivalence of albuterol (a relatively selective β₂-adrenergic drug) was evaluated in 20 asthmatic children (6 to 14 years of age). The study was divided into two phases: a single-blind multiple-dose treatment with placebo and three separate weekly treatments with 2, 4, and 6 mg of albuterol (tablets or syrup) administered four times a day; and a double-blind crossover period comparing 4-mg albuterol tablets to syrup and placebo. Patients recorded daily diaries and were seen weekly. Theophylline, isoproterenol, and/or epinephrine was administered as needed. In phase 1, the 4- and 6-mg albuterol doses were superior with the latter causing more side effects. In phase 2, a 4-mg dose of albuterol was superior to placebo. The syrup formulation was superior to tablets when extra medications (P < .01) and six-hour change in pulmonary function were evaluated; the maximum effect of the 4-mg syrup dose was reached at four hours and lasted for six hours whereas the effect of the tablet peaked at two hours and was minimal after five hours. Heart rate changes from base line were greater with syrup. Four milligrams of albuterol syrup (2 mg/5 ml) four times a day is the preferred dose for the asthmatic child 6 to 14 years of age.