C.W. Bierman

Double-blind evaluation of nebulized cromolyn, terbutaline, and the combination for childhood asthma

To evaluate whether the potency of a long-acting selective beta 2-agonist negates the need for cromolyn, 27 children, aged 6 to 12 years, with mild to moderate asthma requiring long-term medication, were assessed for the therapeutic effects of cromolyn and/or terbutaline by jet nebulizer. Patients received either cromolyn, 20 mg, terbutaline, 0.1 mg/kg up to 4 mg, or the combination, three times daily. The study design was double-blind, crossover with each patient receiving the three treatment regimens in randomized order for a period of 8 weeks each. Daily diary mean scores generally demonstrated best symptom control with cromolyn or the combination than with terbutaline alone. Cough was significantly less with cromolyn than with terbutaline (p less than 0.05). Morning peak flow measures were higher with combination therapy than with terbutaline (p less than 0.05). Evening peak flow measures were higher with the combination and cromolyn alone than with terbutaline alone (p less than 0.01). Methacholine challenge demonstrated less bronchial hyperreactivity with the combination or cromolyn alone than with terbutaline alone (p less than 0.02). The effectiveness of the nebulizer regimen for children with chronic asthma is better when cromolyn is used alone or in combination with terbutaline than when the beta-agonist is used alone.

Albuterol syrup in the treatment of asthma

This study evaluated the administration of albuterol syrup (0.1 mg/kg/6 hr) or placebo to 2- to 6-year old children whose extrinsic asthma was treated with maintenance theophylline in a prerandomized, double-blind crossover study design. Albuterol/theophylline treatment produced peak expiratory flow rates 2 hours after administration that were significantly higher than in the theophylline/placebo-treated group (119.3 L/min versus 83 L/min) p less than 0.01. The theophylline/placebo-treated group also required higher serum concentrations of theophylline to control wheezing, 10.5 micrograms/ml versus 5.0 micrograms/ml (p less than 0.01). The average symptom scores for the albuterol/theophylline-treated patients (72.5) were less than that of theophylline/placebo-treated group (97.6) p less than 0.02. Side effects such as tremor, irritability, or insomnia occurred in only two of 17 patients. Serial EKG recordings demonstrated no evidence of cardiotoxicity, such as arrhythmias, or indication of myocardial injury. The addition of albuterol to theophylline improved control of severe asthma in children 2 to 6 years of age demonstrated by improvement in pulmonary function, decrease in theophylline dosage requirement, and improvement in symptoms. It was free of any known cardiotoxicity.

Bitolterol mesylate in exercise-induced asthma

Exercise-induced asthma is a useful model for evaluating the activity and duration of action of pharmacologic agents of asthma. The main objective of this double-blind, crossover study was to determine the effect of the aerosolized beta-adrenergic agent, bitolterol mesylate, on exercise-induced asthma while its efficacy was being compared with isoproterenol and placebo. Twelve subjects with exercise-induced asthma performed cycloergometer exercise 45 minutes after three inhalations of bitolterol mesylate aerosol (1050 micrograms), or isoproterenol (255 micrograms), or placebo in random sequence. Bitolterol mesylate aerosol was very effective in protecting against exercise-induced asthma. The mean percent maximal decrease of FEV1 after exercise was 5.0% for bitolterol, 22.2% for isoproterenol, and 23.2% for placebo. Subjects experienced skeletal muscle tremor with both bitolterol mesylate (four subjects) and isoproterenol (three subjects), but not with placebo. No other side effects were noted.