Background: Patients with severe asthma require multiple therapies to improve lung function and reduce symptoms. The use of long-acting inhaled β2-agonists plus theophylline in addition to high doses of inhaled corticosteroids (ICSs) for the treatment of severe asthma has not been extensively studied. Objective: The purpose of this study was to investigate the efficacy and safety of salmeterol combined with high-dose ICSs plus theophylline in severe asthma. Methods: We undertook a randomized, placebo-controlled, crossover study to compare the effect of a single dose of inhaled salmeterol (50 µg) or a placebo in patients with severe asthma whose conditions were not being adequately controlled by therapies with high-dose ICSs plus oral theophylline with or without leukotriene receptor antagonists. Results: Twenty patients took part in the trial. Compared with the placebo, the inhalation of salmeterol significantly increased the FEV1. Even in the 9 patients treated with high-dose ICSs plus theophylline plus a leukotriene receptor antagonist, the FEV1 increased significantly more after salmeterol than after the placebo. Conclusion: Patients with severe asthma receiving high-dose ICSs plus theophylline may benefit from the addition of salmeterol.

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