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A one-week dose-ranging study of inhaled salmeterol in children with asthma
S Weinstein1, P Chervinsky, S J Pollard
1Allergy and Asthma Specialists, Medical Group, Huntington Beach, California 92647, USA.
Insights
This study found that salmeterol, at both 21 and 42 micrograms doses, effectively improved bronchodilation in children with asthma. Both dosages demonstrated good safety profiles over a 1-week treatment period.
Area of Science:
- Pediatric Pulmonology
- Pharmacology and Therapeutics
Background:
- Asthma is a common chronic respiratory disease in children.
- Long-acting beta-agonists (LABAs) are used in asthma management, but their safety and efficacy in pediatric populations require thorough evaluation.
Purpose of the Study:
- To evaluate the safety and efficacy of two dosage regimens of salmeterol xinafoate in children aged 4-11 years with mild-to-moderate asthma.
- To compare the bronchodilatory effects and safety profiles of salmeterol 21 micrograms and 42 micrograms administered twice daily.
Main Methods:
- A randomized, double-blind, placebo-controlled, parallel-group, multicenter study.
- 243 children with asthma received salmeterol 21 mcg, salmeterol 42 mcg, or placebo via metered-dose inhaler (MDI) twice daily for 1 week.
- Spirometry and peak expiratory flow rate (PEFR) were measured serially; safety was assessed through adverse events, vital signs, ECG, and Holter monitoring.
Main Results:
- Both salmeterol dosages significantly improved bronchodilation (FEV1 and PEFR) compared to placebo on days 1 and 8 (p < 0.02).
- A trend towards greater improvement in asthma control was observed with the 42 mcg dose.
- Adverse events were infrequent (5%), with headache being the most common (4% in each salmeterol group); no significant safety concerns were identified.
Conclusions:
- Salmeterol at 21 mcg or 42 mcg twice daily is effective for bronchodilation in children aged 4-11 years with mild-to-moderate asthma.
- Both dosages exhibited favorable safety profiles during the 1-week study.
- The higher dose (42 mcg) suggested a potential for greater efficacy in asthma control.
Abstract:
This was a 1-week study evaluating the safety and efficacy of two dosage regimens of salmeterol in children with asthma. A total of 243 children, aged 4-11 years, with mild-to-moderate asthma were enrolled in a randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating salmeterol xinafoate 21 micrograms and 42 micrograms administered via metered-dose inhaler (MDI) twice daily for 1 week. Patients were allowed to use albuterol MDI as needed for relief of acute symptoms. Inhaled corticosteroids and/or cromolyn at fixed dosages could be continued during the study, but theophylline and oral beta-agonists were 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 assessed by monitoring adverse events, clinical laboratory values, vital signs, electrocardiogram (ECG), and 24-hr ECG (Holter) monitoring. Both the 21-micrograms and 42-micrograms doses of salmeterol produced significantly greater bronchodilation, as measured by 12-hr serial forced expiratory volume in 1 sec (FEV1) (p < or = 0.02) and PEFR (p < or = 0.001), than did placebo on days 1 and 8. A small dose-response was observed, with the 42-micrograms dosage producing consistently higher serial FEV1 and PEFR than did the 21-micrograms dosage, although the differences were not statistically significant. Morning and evening PEFR increased significantly (p < or = 0.008) with 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 clinically significant changes in heart rate as measured by Holter monitoring, ECGs, vital signs, or clinical laboratory values following treatment with either dose of salmeterol. Salmeterol 21 micrograms or 42 micrograms twice daily was effective in producing bronchodilation in children aged 4-11 years, and both dosages had good safety profiles. Patients treated with salmeterol 42 micrograms twice daily showed a trend toward greater improvement in asthma control compared with those who received salmeterol 21 micrograms.