title: Olodaterol for the treatment of asthma.
abstract: BACKGROUND
  Long-acting β-agonist (LABA)/inhaled corticosteroid (ICS) combinations are still the mainstay of asthma therapy but there is a pressing need to increase adherence to the prescribed treatment achievable in general by reducing the dose frequency. Consequently, there is considerable interest within the pharmaceutical industry in the discovery of once-daily β2-agonists (ultra-LABAs) to be used as a part of a combination therapy for treating asthma.
  
  
  METHODS
  The authors review the preclinical and clinical development of olodaterol, a new ultra-LABA characterized by an improved selectivity for β2-adrenoceptors and a rather high intrinsic efficacy profile, in asthma. The clinical results were generated by 4 Phase 2 trials, which have enrolled 731 asthmatic patients.
  
  
  CONCLUSIONS
  The available results indicate that olodaterol is able to induce an effective 24-h bronchodilation and is safe. However, one cannot formulate a solid conclusion on the best dose and/or dose frequency to be used in asthma because trials were not powered to assess the differences between doses and dose frequencies. Apparently, there is no Phase 3 trial planned or ongoing for olodaterol monotherapy in patients with asthma and also no attempt to combine olodaterol with an ICS, which is surprising.
authors.affiliation: a Department of Systems Medicine , University of Rome Tor Vergata , Rome , Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Cazzola
authors.affiliation: b Department of Experimental Medicine , Second University of Naples , Naples , Italy.
authors.forename: Barbara
authors.initials: B
authors.lastname: Rinaldi
authors.affiliation: a Department of Systems Medicine , University of Rome Tor Vergata , Rome , Italy.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Lucà
authors.affiliation: a Department of Systems Medicine , University of Rome Tor Vergata , Rome , Italy.
authors.forename: Josuel
authors.initials: J
authors.lastname: Ora
mesh_terms: D058666:Adrenergic beta-2 Receptor Agonists / Q000494:pharmacology / Q000627:therapeutic use; D000818:Animals; D018927:Anti-Asthmatic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D048588:Benzoxazines / Q000494:pharmacology / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000494:pharmacology / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D006801:Humans
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D018927:Anti-Asthmatic Agents; D048588:Benzoxazines; D001993:Bronchodilator Agents; D003692:Delayed-Action Preparations; C549647:olodaterol
keywords: Asthma; long-acting β-agonists; olodaterol; once-daily regimen