Effect of Long-Term Regular Salmeterol Treatment in Children with Moderate Asthma

Abstract

The safety and efficacy of salmeterol 50µg twice daily was compared with placebo (both administered via a Diskhaler™ inhaler) in 91 children (aged between 6 and 15 years) in a double-blind, crossover study consisting of two 6-month treatment periods separated by a 2-week washout. Inhaled salbutamol (albuterol) on an ‘as required’ basis was permitted throughout the study for symptomatic relief. Patients maintained daily records of their peak expiratory flow rate (PEFR), symptom scores and rescue medication use. Methacholine challenge tests (PD20) were conducted at the start, end and 3 and 14 days after cessation of treatment. Salmeterol significantly increased the percentage of symptom-free days (salmeterol 85%; placebo 76%) and nights (salmeterol 90%; placebo 82%). There was a non-significant trend for salmeterol to improve PEFR (mean increase 16 L/min) compared with placebo (mean increase 8 L/min), and no significant difference in methacholine PD20 values or the incidence of asthma exacerbations. The results indicate that regular treatment with salmeterol 50µg twice daily improves symptom control without increasing bronchial reactivity or exacerbation rates. In conclusion, there is no evidence of deterioration in asthma control during long-term salmeterol treatment compared with ‘as required’ salbutamol treatment or rebound increased bronchial hyper-responsiveness on cessation of treatment.