RT Journal Article SR Electronic T1 Efficacy and safety of AZD3199, an inhaled ultra long-acting β2-agonist, in patients with COPD JF European Respiratory Journal JO Eur Respir J FD European Respiratory Society SP p868 VO 38 IS Suppl 55 A1 Kuna, Piotr A1 Ivanov, Yavor A1 Trofimov, Vasily A1 Beckman, Ola A1 Bengtsson, Thomas A1 Jorup, Carin A1 Maltais, Francois YR 2011 UL http://erj.ersjournals.com/content/38/Suppl_55/p868.abstract AB Objective: To study the efficacy and safety of three once-daily doses of AZD3199 inhaled via Turbuhaler compared with twice-daily formoterol and placebo over 4 weeks in COPD patients.Methods: This was a 4-week randomised, double-blind, parallel-group multi-centre Phase II study to compare once-daily inhaled doses of AZD3199 (200, 400 and 800 μg delivered) with formoterol (9 μg bid) and placebo in 329 adults with moderate/severe COPD (NCT00929708). Bronchodilation was assessed by average post-dose FEV1 values from 0–4 hrs (E0-4, peak) and FEV1 values from 24–26 hrs (E24-26, trough). Use of β2-agonist reliever medication, salbutamol reversibility, symptom scores (CCQ) and safety were also assessed.Results: For all 3 doses of AZD3199, FEV1 E0-4 and E24-26 were statistically significantly greater vs. placebo after 4 weeks' treatment (E0-4 106–171 mL, E24-26 96.5–110 mL) but no dose response was seen (Figure). Formoterol bid was superior to placebo for FEV1 E0-4 but not E24-26. All 3 AZD3199 groups used less reliever medication than the placebo group. AZD3199 did not impact on the acute bronchodilating effect of salbutamol. All AZD3199 groups showed a reduction in symptom scores with the 800 μg dose reaching significance vs. formoterol and placebo. AZD3199 was well tolerated with no safety concerns.Conclusions: AZD3199 is a safe and effective uLABA with a 24-hour duration of action.