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 agonists are considered long-term symptom control medications, especially for nocturnal symptoms. Objective: To compare efficacy of an extended release oral beta-2 agonist, albuterol sulfate (Volmax®), to a long-acting inhaled agent, salmeterol (Serevent®) in the treatment of nocturnal asthma. Methods: This was a multicenter double-blind, double-dummy, randomized, crossover design with a 1-week baseline period and two 3-week treatment periods separated by a 7 to 9-day washout. An optional 2-week, open-label phase was 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 similar and significant improvements over the 3-week treatment period for both medications compared with baseline (P < .001). Similar improvements were seen in the overnight change in PEF values (P < .001). The morning and overnight changes in FEV₁ were not significantly different between treatment arms (P > .05). There were significant improvements in both treatment periods in regard to the percentage of nights without awakenings (baseline 53.6 ± 5.3%), extended release albuterol 83.3 ± 3.0% (P < .001), and salmeterol 88.8 ± 2.4%. The percentage of patients who had no awakenings during treatment did not differ significantly for the two medications. Both treatments also resulted in a decrease in the use of rescue albuterol (extended release 2.66 ± 0.35 puffs per day, salmeterol 1.85 ± 0.29) from baseline (4.57 ± 0.41, P < .001). There was a significant difference between groups (P = .001). The reasons why patients preferred one medication over the other varied. Conclusion: Both extended release albuterol tablets and inhaled salmeterol resulted in similar bronchodilation and good control of nocturnal asthma symptoms.