Comparative study of extended release albuterol sulfate and long-acting inhaled salmeterol xinafoate in the treatment of nocturnal asthma

Background: Nocturnal worsening of asthma is a common problem in asthma and is associated with increased morbidity and mortality. Long acting beta-2 a gonists are considered long-term symptom control medications, especially fo r nocturnal symptoms. Objective: To compare efficacy of an extended release oral beta-2 agonist, albuterol sulfate (Volmax(R)), to a long-acting inhaled agent, salmeterol ( Serevent(R)) in the treatment of nocturnal asthma, Methods: This was a multicenter double-blind, double-dummy, randomized, cro ssover design with a 1-week baseline period and two 3-week treatment period s separated by a 7 to 9-day washout. An optional 2-week, open-label phase w as conducted to evaluate patient preference. Results: A total of 46 patients were included in the efficacy analysis, For the primary outcome variable of morning peak expiratory flow, there were s imilar and significant improvements over the 3-week treatment period for bo th medications compared with baseline (P <.001). Similar improvements were seen in the overnight change in PEF values (P <.001), The morning and overn ight changes in FEV, were not significantly different between treatment arm s (P >.05), There were significant improvements in both treatment periods i n regard to the percentage of nights without awakenings (baseline 53.6 +/- 5.3%), extended release albuterol 83.3 +/- 3.0% (P <.001), and salmeterol 8 8.8 +/- 2.4%. The percentage of patients who had no awakenings during treat ment did not differ significantly for the two medications. Both treatments also resulted in a decrease in the use of rescue albuterol (extended releas e 2.66 +/- 0.35 puffs per day, salmeterol 1.85 +/- 0.29) from baseline (4.5 7 +/- 0.41, P <.001), There was a significant difference between groups (P =.001), The reasons why patients preferred one medication over the other va ried. Conclusion: Both extended release albuterol tablets and inhaled salmeterol resulted in similar bronchodilation and good control of nocturnal asthma sy mptoms.