title: Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4).
abstract: Efficacy and safety of tiotropium+olodaterol fixed-dose combination (FDC) compared with the mono-components was evaluated in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in two replicate, randomised, double-blind, parallel-group, multicentre, phase III trials. Patients received tiotropium+olodaterol FDC 2.5/5 μg or 5/5 μg, tiotropium 2.5 μg or 5 μg, or olodaterol 5 μg delivered once-daily via Respimat inhaler over 52 weeks. Primary end points were forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0-3) response, trough FEV1 response and St George's Respiratory Questionnaire (SGRQ) total score at 24 weeks. In total, 5162 patients (2624 in Study 1237.5 and 2538 in Study 1237.6) received treatment. Both FDCs significantly improved FEV1 AUC0-3 and trough FEV1 response versus the mono-components in both studies. Statistically significant improvements in SGRQ total score versus the mono-components were only seen for tiotropium+olodaterol FDC 5/5 μg. Incidence of adverse events was comparable between the FDCs and the mono-components. These studies demonstrated significant improvements in lung function and health-related quality of life with once-daily tiotropium+olodaterol FDC versus mono-components over 1 year in patients with moderate to very severe COPD.
authors.affiliation: Pulmonary Department, Mainz University Hospital, Mainz, Germany r.buhl@3-med.klinik.uni-mainz.de.
authors.forename: Roland
authors.initials: R
authors.lastname: Buhl
authors.affiliation: Département de Médecine, Centre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec, Canada.
authors.forename: François
authors.initials: F
authors.lastname: Maltais
authors.affiliation: Department of Clinical Research, Morgantown Pulmonary Associates, Morgantown, WV, USA.
authors.forename: Roger
authors.initials: R
authors.lastname: Abrahams
authors.affiliation: Department of Respiratory Medicine and Allergology, Lund University, Lund, Sweden.
authors.forename: Leif
authors.initials: L
authors.lastname: Bjermer
authors.affiliation: Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
authors.forename: Eric
authors.initials: E
authors.lastname: Derom
authors.affiliation: Pulmonary Research Institute of Southeast Michigan, Livonia, MI, USA.
authors.forename: Gary
authors.initials: G
authors.lastname: Ferguson
authors.affiliation: Klinika Golnik, Golnik, Slovenia.
authors.forename: Matjaž
authors.initials: M
authors.lastname: Fležar
authors.affiliation: Department of Medicine, Centre de Recherche Appliquée en Allergie de Québec (CRAAQ), Québec, Canada.
authors.forename: Jacques
authors.initials: J
authors.lastname: Hébert
authors.affiliation: Department of Medicine, Centre for Infection and Immunity, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.
authors.forename: Lorcan
authors.initials: L
authors.lastname: McGarvey
authors.affiliation: Department of Pulmonology, NUPAIVA (Asthma Research Centre), Universidade Federal de Santa Catarina, Santa Catarina, Brazil.
authors.forename: Emilio
authors.initials: E
authors.lastname: Pizzichini
authors.affiliation: Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
authors.forename: Jim
authors.initials: J
authors.lastname: Reid
authors.affiliation: Department of Respiratory Medicine, The Queen Elizabeth Hospital, Adelaide, Australia.
authors.forename: Antony
authors.initials: A
authors.lastname: Veale
authors.affiliation: Department of Medical Affairs Respiratory, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: Lars
authors.initials: L
authors.lastname: Grönke
authors.affiliation: Medical Department, Boehringer Ingelheim, Burlington, Ontario, Canada.
authors.forename: Alan
authors.initials: A
authors.lastname: Hamilton
authors.affiliation: Department of Biostatistics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Korducki
authors.affiliation: Department of Medical Affairs Respiratory, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany Department of Sports Medicine, Medical Clinic V, University of Tübingen, Tübingen, Germany.
authors.forename: Kay
authors.initials: K
authors.lastname: Tetzlaff
authors.affiliation: Medical Department, Boehringer Ingelheim B.V., Alkmaar, The Netherlands.
authors.forename: Stella
authors.initials: S
authors.lastname: Waitere-Wijker
authors.affiliation: Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research, Grosshansdorf, Germany.
authors.forename: Henrik
authors.initials: H
authors.lastname: Watz
authors.affiliation: Division of Pulmonology, Department of Medicine, University of Cape Town Lung Institute, Cape Town, South Africa.
authors.forename: Eric
authors.initials: E
authors.lastname: Bateman
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D048588:Benzoxazines / Q000008:administration & dosage*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D038622:Internationality; D008297:Male; D020714:Maximum Tolerated Dose; D036501:Metered Dose Inhalers; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy*; D018570:Risk Assessment; D012720:Severity of Illness Index; D013147:Spirometry; D000069447:Tiotropium Bromide / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D048588:Benzoxazines; D001993:Bronchodilator Agents; C549647:olodaterol; D000069447:Tiotropium Bromide