A ONE-WEEK DOSE-RANGING STUDY OF INHALED SALMETEROL IN CHILDREN WITH ASTHMA

This was a 1-week study evaluating the safety and efficacy of two dosa ge regimens of salmeterol in children with asthma. A total of 243 chil dren, aged 4-11 years, with mild-to-moderate asthma were enrolled in a randomized, double-blind, placebo-controlled, parallel-group, multice nter study evaluating salmeterol xinafoate 21 mu g and 42 mu g adminis tered via metered-dose inhaler (MDI) twice daily for 1 week. Patients were allowed to use albuterol MDI as needed for relief of acute sympto ms. Inhaled corticosteroids and/or cromolyn at fixed dosages could be continued during the study, but theophylline and oral beta-agonists we re not allowed. Twelve-hour serial spirometry (for patients aged 6-11 years) and serial peak expiratory flow rate (PEFR) (all patients) were performed on days 1 and 8 of treatment; morning and evening PEFR were recorded each day prior to inhalation of the study drug. Safety was a ssessed by monitoring adverse events, clinical laboratory values, vita l signs, electrocardiogram (EGG), and 24-hr ECG (Holter) monitoring. B oth the 21-mu g and 42-mu g doses of salmeterol produced significantly greater bronchodilation, as measured by 12-hr serial forced expirator y volume in 1 sec (FEV(1)) (p less than or equal to 0.02) and PEFR (p less than or equal to 0.001), than did placebo on days 1 and 8. A smal l dose-response was observed, with the 42-mu g dosage producing consis tently higher serial FEV(1) and PEFR than did the 21-mu g dosage, alth ough the differences were not statistically significant. Morning and e vening PEFR increased significantly (p less than or equal to 0.008) wi th both dosages of salmeterol compared with placebo. Twelve patients ( 5%) experienced potentially drug-related adverse events, with headache (4% in each salmeterol group) being the most common. There were no cl inically significant changes in heart rate as measured by Holter monit oring, ECGs, vital signs, or clinical laboratory values following trea tment with either dose of salmeterol. Salmeterol 21 mu g or 42 mu g tw ice daily was effective in producing bronchodilation in children aged 4-11 years, and both dosages had good safety profiles. Patients treate d with salmeterol 42 mu g twice daily showed a trend toward greater im provement in asthma control compared with those who received salmetero l 21 mu g.