title: Efficacy and safety of olodaterol once daily delivered via Respimat® in patients with GOLD 2-4 COPD: results from two replicate 48-week studies.
abstract: BACKGROUND
  Olodaterol is a long-acting β2-agonist with a 24-hour bronchodilator profile. Two replicate, randomized, double-blind, placebo-controlled, parallel-group, Phase III trials were performed as part of a comprehensive clinical program to investigate the long-term safety and efficacy of olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving usual-care background therapy.
  
  
  METHODS
  Patients received olodaterol 5 μg or 10 μg or placebo once daily for 48 weeks. Coprimary end points were forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 3 hours (AUC0-3) response (change from baseline), and trough FEV1 response at 12 weeks. Secondary end points included additional lung function assessments, use of rescue medications, FEV1 AUC response from 0 to 12 hours, and Patient Global Rating over 48 weeks.
  
  
  RESULTS
  Overall, 624 and 642 patients were evaluated in studies 1222.11 and 1222.12, respectively. In both studies, olodaterol 5 μg and 10 μg significantly improved the FEV1 AUC0-3 response (P<0.0001) and trough FEV1 (study 1222.11, P<0.0001; study 1222.12, P<0.05, post hoc) at week 12, with an incidence of adverse events comparable with that of placebo. Secondary end points supported the efficacy of olodaterol.
  
  
  CONCLUSIONS
  These studies demonstrate the long-term efficacy and safety of once-daily olodaterol 5 μg and 10 μg in patients with moderate to very severe COPD continuing with usual-care maintenance therapy.
authors: Pulmonary Research Institute of Southeast Michigan, Livonia, MI, USA.
authors: Gary T
authors: GT
authors: Ferguson
authors: S Carolina Pharmaceutical Research, Spartanburg, SC, USA.
authors: Gregory J
authors: GJ
authors: Feldman
authors: Pneumologie, Weinheim, Germany.
authors: Peter
authors: P
authors: Hofbauer
authors: Boehringer Ingelheim, Burlington, ON, Canada.
authors: Alan
authors: A
authors: Hamilton
authors: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
authors: Lisa
authors: L
authors: Allen
authors: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
authors: Lawrence
authors: L
authors: Korducki
authors: Pulmonary Associates of Stamford, Stamford, CT, USA.
authors: Paul
authors: P
authors: Sachs
mesh_terms: D000280:Administration, Inhalation; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000368:Aged; D019540:Area Under Curve; D001208:Asia; D001315:Australia; D048588:Benzoxazines / Q000008:administration & dosage* / Q000009:adverse effects; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004867:Equipment Design; D005260:Female; D005541:Forced Expiratory Volume; D005858:Germany; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D009520:New Zealand; D011237:Predictive Value of Tests; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D048588:Benzoxazines; D001993:Bronchodilator Agents; C549647:olodaterol
keywords: bronchodilator; chronic obstructive pulmonary disease; olodaterol