Guy F Joos1, Joseph-Leon Aumann2, Carl Coeck3, Lawrence Korducki4, Alan L Hamilton5, Christina Kunz6, René Aalbers7. 1. Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium. Electronic address: guy.joos@ugent.be. 2. Longartsenpraktijk, Hasselt, Belgium. 3. SCS Boehringer Ingelheim Comm. V, Brussels, Belgium. 4. Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA. 5. Boehringer Ingelheim, Burlington, Ontario, Canada. 6. Boehringer Ingelheim, Pharma GmbH & Co. KG, Biberach an der Riss, Germany. 7. Department of Pulmonary Disease, Martini Hospital, Groningen, The Netherlands.
Abstract
BACKGROUND: This randomised, double-blind, four-way, crossover, Phase II study compared the 24-h forced expiratory volume in 1 s (FEV1) profile of alternative dosing frequencies of two total daily doses of olodaterol (5 and 10 μg) in patients with chronic obstructive pulmonary disease (COPD). METHODS: Patients received olodaterol 2 μg twice daily (BID), 5 μg BID, 5 μg once daily (QD) and 10 μg QD in a randomised sequence over 3-week treatment periods. Co-primary end points were FEV1 area under the curve from 0 to 12 h (AUC0-12) and area under the curve from 12 to 24 h (AUC12-24) responses. Additional lung-function responses, pharmacokinetics and safety were assessed. RESULTS:47 patients were treated. All olodaterol doses provided significant increases in FEV1 versus baseline (p < 0.001) and FEV1 time profiles were nearly identical for olodaterol 5 and 10 μg QD. Olodaterol 5 μg QD demonstrated improved FEV1 AUC0-12 and similar AUC12-24 versus 2 μg BID. Olodaterol 5 μg QD showed slightly increased FEV1 AUC0-12 but lower AUC12-24 compared to 5 μg BID. Bronchodilation over 24 h was similar for olodaterol 5 μg QD and BID. All doses were well tolerated. CONCLUSIONS:Olodaterol 5 μg QD is efficacious in COPD, with a superior bronchodilatory profile compared to 2 μg BID, which is close to the same total daily dose, and a similar degree of bronchodilation over 24 h compared with double the daily dose (administered as 10 μg QD or 5 μg BID). TRIAL REGISTRATION: ClinicalTrials.gov: NCT00846768.
RCT Entities:
BACKGROUND: This randomised, double-blind, four-way, crossover, Phase II study compared the 24-h forced expiratory volume in 1 s (FEV1) profile of alternative dosing frequencies of two total daily doses of olodaterol (5 and 10 μg) in patients with chronic obstructive pulmonary disease (COPD). METHODS:Patients received olodaterol 2 μg twice daily (BID), 5 μg BID, 5 μg once daily (QD) and 10 μg QD in a randomised sequence over 3-week treatment periods. Co-primary end points were FEV1 area under the curve from 0 to 12 h (AUC0-12) and area under the curve from 12 to 24 h (AUC12-24) responses. Additional lung-function responses, pharmacokinetics and safety were assessed. RESULTS: 47 patients were treated. All olodaterol doses provided significant increases in FEV1 versus baseline (p < 0.001) and FEV1 time profiles were nearly identical for olodaterol 5 and 10 μg QD. Olodaterol 5 μg QD demonstrated improved FEV1 AUC0-12 and similar AUC12-24 versus 2 μg BID. Olodaterol 5 μg QD showed slightly increased FEV1 AUC0-12 but lower AUC12-24 compared to 5 μg BID. Bronchodilation over 24 h was similar for olodaterol 5 μg QD and BID. All doses were well tolerated. CONCLUSIONS:Olodaterol 5 μg QD is efficacious in COPD, with a superior bronchodilatory profile compared to 2 μg BID, which is close to the same total daily dose, and a similar degree of bronchodilation over 24 h compared with double the daily dose (administered as 10 μg QD or 5 μg BID). TRIAL REGISTRATION: ClinicalTrials.gov: NCT00846768.
Authors: Andrea Koch; Emilio Pizzichini; Alan Hamilton; Lorna Hart; Lawrence Korducki; Maria Cristina De Salvo; Pierluigi Paggiaro Journal: Int J Chron Obstruct Pulmon Dis Date: 2014-07-05
Authors: Gregory J Feldman; Jonathan A Bernstein; Alan Hamilton; Michael C Nivens; Lawrence Korducki; Craig LaForce Journal: Springerplus Date: 2014-08-09
Authors: Gary T Ferguson; Gregory J Feldman; Peter Hofbauer; Alan Hamilton; Lisa Allen; Lawrence Korducki; Paul Sachs Journal: Int J Chron Obstruct Pulmon Dis Date: 2014-06-16