SALMETEROL IN NOCTURNAL ASTHMA - A DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL OF A LONG-ACTING INHALED BETA-2 AGONIST

Objective - To determine whether inhaled salmeterol, a new long acting inhaled beta-adrenergic agonist, reduces nocturnal bronchoconstriction and improved sleep quality in patients with nocturnal asthma. Design - Randomised, double blind, placebo controlled crossover study. Setting - Hospital outpatient clinics in Edinburgh. Subjects - Twenty clinically stable patients (13 women, seven men) with nocturnal asthma, median age 39 (range 18-60) years. Interventions - Salmeterol 50-mu-g and 100-mu-g and placebo taken each morning and evening by metered dose inhaler. Rescue salbutamol inhalers were provided throughout the run in and study periods. Main outcome measures - Improvement in nocturnal asthma as measured by peak expiratory flow rates and change in sleep quality as measured by electroencephalography. Results - Salmeterol improved the lowest overnight peak flow rate at both 50-mu-g (difference in median values (95% confidence interval for difference in medians) 69 (18 to 88) 1/min) and 100-mu-g (72(23 to 61) 1/min) doses twice daily. While taking salmeterol 50-mu-g twice daily patients had an objective improvement in sleep quality, spending less time awake or in light sleep (-9(-4 to -44) min) and more time in stage 4 sleep (26 (6-34) min). Conclusions - Salmeterol is an effective long acting inhaled bronchodilator for patients with nocturnal asthma and at a dose of 50-mu-g twice daily improves objective sleep quality.