Background: PT027 is a fixed-dose combination of albuterol (salbutamol) and budesonide in a single pressurized metered-dose inhaler. Objective: To evaluate the efficacy and safety of albuterol/budesonide compared with placebo in patients with asthma and exercise-induced bronchoconstriction (EIB). Methods: In this randomized, double-blind, 2-period, single-dose crossover study, adolescents and adults with asthma and EIB (defined by >= 20 decrease from pre-exercise challenge forced expiratory volume in 1 second FEV1) were randomized to albuterol/budesonide (180/160 mu g) followed by placebo (n = 29) or the reverse sequence (n = 31). Subjects were stratified by background therapy (as-needed short-acting beta(2)-agonist alone or low-to-medium dose inhaled corticosteroid plus as-needed short-acting beta(2)-agonist). FEV1 was measured 5 minutes pre-dose, 30 minutes postdose (5 minutes pre-exercise challenge baseline), and 5, 10, 15, 30, and 60 minutes postexercise. The primary end point was maximum percentage fall from baseline in FEV1 up to 60 minutes postexercise challenge. Results: Least squares mean maximum percentage fall in FEV1 up to 60 minutes postexercise challenge was 5.45 with albuterol/budesonide vs 18.97 with placebo (difference, -13.51 95 confidence interval, -16.94 to -10.09; P < .001). More subjects were fully protected (maximum percentage fall in FEV1 post-exercise challenge < 10) with albuterol/budesonide than with placebo (78.3 vs 28.3; P < .001). The treatment effect was consistent irrespective of background inhaled corticosteroid therapy, and albuterol/budesonide was well tolerated. Conclusion: In adolescents and adults with asthma and EIB, a single dose of albuterol/budesonide 180/160 mg taken approximately 30 minutes before exercise was significantly more effective than placebo in preventing EIB. (C) 2021 American College of Allergy, Asthma Immunology. Published by Elsevier Inc.
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