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Clinical Trial
. 1999 Aug;83(2):121-6.
doi: 10.1016/S1081-1206(10)62622-1.

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

R J Martin  1 , M Kraft, W N Beaucher, F Kiechel, J L Sublett, N LaVallee, J Shilstone
Affiliations
Clinical Trial

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

R J Martin et al. Ann Allergy Asthma Immunol. 1999 Aug.

Abstract

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.

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