TY - JOUR T1 - Effect of budesonide/formoterol, budesonide and terbutaline on exercise-induced bronchoconstriction in mild intermittent asthma JF - European Respiratory Journal JO - Eur Respir J VL - 38 IS - Suppl 55 SP - p3957 AU - Nikolaos Lazarinis AU - Leif Bjermer AU - Kai-Håkon Carlsen AU - Barbro Dahlén AU - Tommy Ekström AU - Gunilla Hedlin AU - Leif Jörgensen AU - Teet Pullerits AU - Kjell Larsson Y1 - 2011/09/01 UR - http://erj.ersjournals.com/content/38/Suppl_55/p3957.abstract N2 - Objectives: To compare the protective effect over 6 weeks of budesonide/formoterol (B/F) as-needed, budesonide (B) once daily, and terbutaline (T) as-needed on exercise induced bronchoconstriction (EIB) in adults and adolescents.Methods: Randomized, double-blind, double-dummy, multicenter, parallel group study (NCT00989833). Patients with EIB (fall in FEV1 ≥10% from pre-exercise baseline) were treated with either B/F 160/4.5 mg prn, B 400 mg od + T 0.4 mg prn, or T 0.4 mg prn. All subjects should exercise 3-4 times/week and use B/F or T pre-exercise and for symptom relief during the study. The primary variable (max fall in FEV1 post standardized exercise challenge + dry air inhalation) was investigated by covariance analysis. Symptoms from diary and ACQ were collected.Results: 66 patients were randomized. Both B/F and B were superior to T in protecting against EIB. Mean reduction in post-exercise FEV1 compared with baseline was 5.4% for B/F (p=0.017 vs T), 6.6% for B (p=0.0026 vs T) vs an enhanced bronchoconstriction of 1.5% for T. The effect of B/F and B did not differ significantly (p=0.58). Similar differences between groups were noted for area under the FEV1 curve and average fall in FEV1. No difference was observed between B/F, B and T in patient reported symptoms and ACQ. The mean total budesonide dose was higher in the B group (393mg) than in the B/F group (163 mg).Conclusion: B/F before exercise and as needed is equally effective as regular once daily B in protection of EIB in patients with mild intermittent asthma and more effective than standard treatment with a short-acting beta-agonist used before exercise and as needed.Sponsored by AstraZeneca. ER -