A randomised, placebo-controlled, Phase II, dose-ranging trial of once-daily treatment with olodaterol, a novel long-acting β2-agonist, for 4 weeks in patients with chronic obstructive pulmonary disease

Respiratory Medicine

Volumn 109, Issue 5, 2015, Pages 596-605

  Maleki Yazdi, M Reza ^a   Beck, Ekkehard ^b   Hamilton, Alan L ^c   Korducki, Lawrence ^d   Koker, Paul ^d   Fogarty, Charles ^e  

^a UNIVERSITY OF TORONTO   (Canada)

^b Institut für Gesundheitsförderung   (Germany)

^c BOEHRINGER INGELHEIM CANADA LTD   (Canada)

^d BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^e Southeast Clinical Oncology Research   (United States)

Author keywords

COPD; Long acting 2 agonist; Olodaterol; Once daily

Indexed keywords

OLODATEROL; PLACEBO; BENZOXAZINE DERIVATIVE; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; BRONCHODILATING AGENT;

ADULT; AREA UNDER THE CURVE; ARTICLE; BRONCHITIS; CHRONIC OBSTRUCTIVE LUNG DISEASE; COLON DIVERTICULOSIS; CONTROLLED STUDY; COUGHING; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG EXCRETION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FAINTNESS; FEMALE; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; GASTROINTESTINAL HEMORRHAGE; HEART PALPITATION; HIP FRACTURE; HUMAN; HUMERUS FRACTURE; LUNG CANCER; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; PARALLEL DESIGN; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SINUSITIS; SOFT MIST INHALER; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; AGED; CLINICAL TRIAL; DRUG ADMINISTRATION; DRUG EFFECTS; INHALATIONAL DRUG ADMINISTRATION; LUNG FUNCTION TEST; METABOLISM; MIDDLE AGED; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE;

ADMINISTRATION, INHALATION; ADRENERGIC BETA-2 RECEPTOR AGONISTS; AGED; BENZOXAZINES; BRONCHODILATOR AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; FORCED EXPIRATORY VOLUME; HUMANS; MALE; MIDDLE AGED; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RESPIRATORY FUNCTION TESTS;

EID: 84940783268     PISSN: 09546111     EISSN: 15323064     Source Type: Journal    
DOI: 10.1016/j.rmed.2015.02.012     Document Type: Article

References (24)

1. World Health Organization The global burden of disease 2004 Update 2008 Available from: http://www.who.int/healthinfo/global-burden-disease/GBD-report-2004update-full.pdf [accessed 21.11.14]
2. Global Initiative for Chronic Obstructive Lung Disease Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease Updated 2013 2013 Available from: http://www.goldcopd.org/uploads/users/files/GOLD-Report-2013-Feb20.pdf [accessed 17.02.15]
3. G. Boyd, A.H. Morice, J.C. Pounsford, M. Siebert, N. Peslis, C. Crawford, and et al. An evaluation of salmeterol in the treatment of chronic obstructive pulmonary disease (COPD) Eur Respir J 10 1997 815 821 10.1183/09031936.97.10040815
4. D.P. Tashkin, and L.M. Fabbri Long-acting beta-agonists in the management of chronic obstructive pulmonary disease: current and future agents Respir Res 11 2010 149
5. 2-agonist therapy in lung disease Am J Respir Crit Care Med 187 2013 690 696 10.1164/rccm.201209-1739PP
6. E. Ridolo, M. Montagni, E. Olivieri, G.G. Riario-Sforza, and C. Incorvaia Role of indacaterol and the newer very long-acting β2-agonists in patients with stable COPD: a review Int J Chron Obstruct Pulmon Dis 8 2013 425 432 10.2147/COPD.S49179
7. F. Maltais, E. Beck, D. Webster, M.R. Maleki-Yazdi, J.-V. Seibt, A. Arnoux, and et al. Four weeks once daily treatment with tiotropium+olodaterol (BI 1744) fixed dose combination compared with tiotropium in COPD patients Eur Respir J 36 Suppl. 54 2010 1014s (abs 5557)
8. M. Cazzola, and M.G. Matera Novel long-acting bronchodilators for COPD and asthma Br J Pharmacol 155 2008 291 299 10.1038/bjp.2008.284
9. 2-adrenoceptor agonist with a 24 h bronchodilatory efficacy Bioorg Med Chem Lett 20 2010 1410 1414
10. 2-adrenoceptor agonist exerting a 24-hour-long duration of action in preclinical models J Pharmacol Exp Ther 334 2010 53 62
11. 2-agonist olodaterol in COPD Pulm Pharmacol Ther 24 2011 666 672
12. G.T. Ferguson, G.J. Feldman, P. Hofbauer, A. Hamilton, L. Allen, L. Korducki, and et al. Efficacy and safety of olodaterol once daily delivered via Respimat®in patients with GOLD 2-4 COPD: results from two replicate 48-week studies Int J Chron Obstruct Pulmon Dis 9 2014 629 645 10.2147/COPD.S61717
13. 1 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 Springerplus 3 2014 419
14. P. Lange, J.-L. Aumann, A. Hamilton, K. Tetzlaff, N. Ting, and E. Derom The 24 hour lung function time profile of olodaterol once daily versus placebo and tiotropium in patients with moderate to very severe chronic obstructive pulmonary disease J Pulm Respir Med 4 2014 196 10.4172/2161-105X.1000196
15. ® versus placebo and formoterol twice daily in patients with GOLD 2-4 COPD: results from two replicate 48-week studies Int J Chron Obstruct Pulmon Dis 9 2014 697 714 10.2147/COPD.S62502
16. R.A. Pauwels, A.S. Buist, P.M.A. Calverley, C.R. Jenkins, S.S. Hurd on behalf of the GOLD Scientific Committee Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO global initiative for chronic obstructive lung disease (GOLD) workshop summary Am J Respir Crit Care Med 163 2001 1256 1276
17. M.R. Miller, J. Hankinson, V. Brusasco, F. Burgos, R. Casaburi, A. Coates, and et al. Standardisation of spirometry Eur Respir J 26 2005 319 338 10.1183/09031936.05.00034805
18. F.P.V. Maesen, J.J. Smeets, T.J.H. Sledsens, F.D.M. Wald, P.J.G. Cornelissen on behalf of a Dutch study group Tiotropium bromide, a new long-acting antimuscarinic bronchodilator: a pharmacodynamic study in patients with chronic obstructive pulmonary disease (COPD) Eur Respir J 8 1995 1506 1513 10.1183/09031936.95.08091506
19. P.M. O'Byrne, T. D'Urzo, M. Gahlemann, L. Hart, F. Wang, and E. Beck Dose-finding study of once-daily treatment with olodaterol, a novel long-acting β2-agonist, in patients with asthma Am J Respir Crit Care Med 185 2012 abs A3963
20. J.A. van Noord, ThA. Bantje, M.E. Eland, L. Korducki, P.J.G. Cornelissen on behalf of the Dutch Tiotropium Study Group A randomised controlled comparison of tiotropium and ipratropium in the treatment of chronic obstructive pulmonary disease Thorax 55 2000 289 294
21. R. Casaburi, D.D. Briggs Jr., J.F. Donohue, C.W. Serby, S.S. Menjoge, T.J. Witek Jr., and et al. The spirometric efficacy of once-daily dosing with tiotropium in stable COPD. A 13-week multicenter trial Chest 118 2000 1294 1302
22. R.D. Restrepo, M.T. Alvarez, L.D. Wittnebel, H. Sorenson, R. Wettstein, D.L. Vines, and et al. Medication adherence issues in patients treated for COPD Int J Chron Obstruct Pulmon Dis 3 2008 371 384
23. S.C. Lareau, and B.P. Yawn Improving adherence with inhaler therapy in COPD Int J Chron Obstruct Pulmon Dis 5 2010 401 406
24. 1 profile for once-daily versus twice-daily treatment with olodaterol, a novel long-acting β2 agonist, in patients with COPD Poster A2930 presented at the 103rd Annual International Conference of the American Thoracic Society, San Francisco, California, USA May 2012