RT Journal Article SR Electronic T1 Safety of formoterol by Turbuhaler® as reliever medication compared with terbutaline in moderate asthma JF European Respiratory Journal JO Eur Respir J FD European Respiratory Society SP 859 OP 866 DO 10.1183/09031936.02.00278302 VO 20 IS 4 A1 P.W. Ind A1 C. Villasante A1 R.J. Shiner A1 A. Pietinalho A1 N.G. Böszörményi A1 S. Soliman A1 O. Selroos YR 2002 UL http://erj.ersjournals.com/content/20/4/859.abstract AB The present study compared the safety of 4.5 µg formoterol with 0.5 mg terbutaline, both by Turbuhaler® and used as needed, in addition to regular formoterol in moderate asthma. In this double-blind parallel-group study, 357 patients taking a moderate-to-high dose of inhaled corticosteroids and additional terbutaline (2–5 inhalations·day−1 during run-in) were randomised to either formoterol or terbutaline as needed in addition to formoterol 9 µg b.i.d. over 12 weeks. Adverse events, serum potassium levels, electrocardiogram, vital signs and lung function were assessed monthly; peak expiratory flow and severe asthma exacerbations were recorded daily. Patients used 2.16 (range 0.0–6.3) formoterol and 2.34 (range 0.1–7.5) terbutaline relief inhalations·day−1. No clinically significant differences in safety variables were found between treatments. Statistically greater increases in cardiac frequency (2.6 beats·min−1, p=0.03) were found on terbutaline. There were 44 and 52 severe asthma exacerbations with formoterol and terbutaline, respectively, with no significant difference in time to first exacerbation. There was also no difference between treatments for other efficacy measures (peak expiratory flow, forced expiratory volume in one second and morning/evening symptom scores). Formoterol 4.5 µg as needed was at least as safe, well tolerated and effective as terbutaline 0.5 mg in stable patients (requiring up to 6 relief inhalations·day−1) taking formoterol plus inhaled corticosteroids regularly over 12 weeks. This study was supported by AstraZeneca R&D Lund, Lund, Sweden.