PT  - JOURNAL ARTICLE
AU  - Kuna, Piotr
AU  - Ivanov, Yavor
AU  - Trofimov, Vasily
AU  - Beckman, Ola
AU  - Bengtsson, Thomas
AU  - Jorup, Carin
AU  - Maltais, Francois
TI  - Efficacy and safety of AZD3199, an inhaled ultra long-acting β<sub>2</sub>-agonist, in patients with COPD
DP  - 2011 Sep 01
TA  - European Respiratory Journal
PG  - p868
VI  - 38
IP  - Suppl 55
4099  - http://erj.ersjournals.com/content/38/Suppl_55/p868.short
4100  - http://erj.ersjournals.com/content/38/Suppl_55/p868.full
SO  - Eur Respir J2011 Sep 01; 38
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.