title: The 24-h FEV1 time profile of olodaterol once daily via Respimat® and formoterol twice daily via Aerolizer® in patients with GOLD 2-4 COPD: results from two 6-week crossover studies.
abstract: These studies evaluated the 24-h forced expiratory volume in 1 sec (FEV1) profile of once-daily (QD) olodaterol compared to placebo and twice-daily (BID) formoterol in patients with moderate to very severe chronic obstructive pulmonary disease. In two replicate, randomized, double-blind, double-dummy, four-way crossover studies, patients received olodaterol 5 and 10 μg QD, formoterol 12 μg BID, or placebo for 6 weeks in addition to usual-care background maintenance therapy. Co-primary end points were FEV1 area under the curve from 0-12 h (AUC0-12) response (change from baseline) and FEV1 AUC from 12-24 h (AUC12-24) response after 6 weeks, with FEV1 AUC from 0-24 h response identified as a key secondary end point. Other secondary end points included FEV1 AUC from 0-3 h and trough FEV1 responses, as well as corresponding forced vital capacity responses. With both olodaterol doses, FEV1 increased to near-maximal 30 min post-morning dose, which was sustained over 24 h. FEV1 also increased within 30 min post-morning dose of formoterol and was sustained over 12 h; the second formoterol dose resulted in a further increase, sustained for an additional 12 h. FEV1 AUC0-12 and AUC12-24 responses with both QD olodaterol doses and BID formoterol were significantly greater than placebo at 6 weeks (P < .0001). Secondary end-point outcomes were consistent with those of the co-primary end points. These data, together with those from the wider phase III clinical program, provide evidence for the 24-h bronchodilator efficacy of olodaterol QD in this patient population.
  
  
  BACKGROUND
  ClinicalTrials.gov; NCT00931385 and NCT00932646.
authors.affiliation: S. Carolina Pharmaceutical Research, 141 Harold Fleming Court, North Grove Medical Park, Spartanburg, South Carolina 29303 USA.
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Feldman
authors.affiliation: Department of Internal Medicine, Bernstein Clinical Research Center, Cincinnati, Ohio USA.
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: Bernstein
authors.affiliation: Boehringer Ingelheim, Burlington, Ontario Canada.
authors.forename: Alan
authors.initials: A
authors.lastname: Hamilton
authors.affiliation: Boehringer Ingelheim Pharmaceuticals Inc, Biberach an der Riss, Germany.
authors.forename: Michael C
authors.initials: MC
authors.lastname: Nivens
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ridgefield, Connecticut USA.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Korducki
authors.affiliation: North Carolina Clinical Research, Raleigh, North Carolina USA.
authors.forename: Craig
authors.initials: C
authors.lastname: LaForce