title: Tiotropium + olodaterol shows clinically meaningful improvements in quality of life.
abstract: BACKGROUND
  Tiotropium + olodaterol improves lung function and symptoms compared to monotherapies in chronic obstructive pulmonary disease (COPD). The OTEMTO 1 and 2 studies investigated the effects of tiotropium + olodaterol on lung function and health-related quality of life compared to placebo in patients with moderate to severe COPD.
  
  
  METHODS
  In these two replicate, double-blind, parallel-group, placebo-controlled trials, patients were randomised to receive tiotropium + olodaterol 5/5 μg, 2.5/5 μg, tiotropium 5 μg or placebo for 12 weeks, via the Respimat(®) inhaler. Primary end points were St George's Respiratory Questionnaire (SGRQ) total score, forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0-3) response and trough FEV1 response.
  
  
  RESULTS
  In OTEMTO 1 and 2, tiotropium + olodaterol 5/5 μg improved SGRQ total score by 4.89 (95% confidence interval [CI] -6.90, -2.88) and 4.56 (95% CI -6.50, -2.63) units versus placebo (both p < 0.0001), and 2.49 (95% CI -4.47, -0.51; p < 0.05) and 1.72 (95% CI -3.63, 0.19) units versus tiotropium 5 μg. Tiotropium + olodaterol 2.5/5 μg significantly improved SGRQ score compared to placebo. Both doses significantly improved FEV1 AUC0-3 response compared to placebo and tiotropium 5 μg. Tiotropium + olodaterol 5/5 and 2.5/5 μg also significantly improved trough FEV1 response compared to placebo (both studies) and separated from tiotropium 5 μg in OTEMTO 2. Adverse-event incidence was similar between treatment groups.
  
  
  CONCLUSIONS
  Tiotropium + olodaterol improved lung function and quality of life compared to placebo and tiotropium 5 μg.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01964352 and NCT02006732.
authors: The Medicines Evaluation Unit, Manchester, UK. Electronic address: dsingh@meu.org.uk.
authors: Dave
authors: D
authors: Singh
authors: Pulmonary Research Institute of Southeast Michigan, Livonia, MI, USA.
authors: Gary T
authors: GT
authors: Ferguson
authors: Krankenhaus der Elisabethinen, Linz, Austria.
authors: Josef
authors: J
authors: Bolitschek
authors: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors: Lars
authors: L
authors: Grönke
authors: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors: Christoph
authors: C
authors: Hallmann
authors: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
authors: Nathan
authors: N
authors: Bennett
authors: Morgantown Pulmonary Associates, Morgantown, WV, USA.
authors: Roger
authors: R
authors: Abrahams
authors: Lungen- und Bronchialheilkunde, Koblenz, Germany.
authors: Olaf
authors: O
authors: Schmidt
authors: Department of Respiratory Medicine and Allergology, Lund University, Lund, Sweden.
authors: Leif
authors: L
authors: Bjermer
mesh_terms: D000280:Administration, Inhalation; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage*; D000368:Aged; D048588:Benzoxazines / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage*; D009330:Nebulizers and Vaporizers; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D011788:Quality of Life; D012129:Respiratory Function Tests / Q000379:methods; D000069447:Tiotropium Bromide / Q000008:administration & dosage*
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D048588:Benzoxazines; D018727:Muscarinic Antagonists; C549647:olodaterol; D000069447:Tiotropium Bromide
keywords: COPD; Long-acting bronchodilator; Olodaterol; Quality of life; Tiotropium