The 24-h lung-function profile of once-daily tiotropium and olodaterol fixed-dose combination in chronic obstructive pulmonary disease.

Autor: Beeh KM; Insaf GmbH Institut für Atemwegsforschung, Wiesbaden, Germany. Electronic address: k.beeh@insaf-wi.de., Westerman J; Pulmonary and Sleep Associates of Jasper, Jasper, AL, USA., Kirsten AM; Pulmonary Research Institute at LungClinic Grosshansdorf GmbH, Airway Research Center North, Grosshansdorf, Germany., Hébert J; Centre de Recherche Appliquée en Allergie de Québec, Québec, Canada., Grönke L; Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany., Hamilton A; Boehringer Ingelheim, Burlington, Ontario, Canada., Tetzlaff K; Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany; Department of Sports Medicine, Medical Clinic V, University of Tübingen, Tübingen, Germany., Derom E; Ghent University Hospital, Ghent, Belgium.
Jazyk: angličtina
Zdroj: Pulmonary pharmacology & therapeutics [Pulm Pharmacol Ther] 2015 Jun; Vol. 32, pp. 53-9. Date of Electronic Publication: 2015 May 06.
DOI: 10.1016/j.pupt.2015.04.002
Abstrakt: Background: This study investigated the effects on 24-h lung function and lung volume of a once-daily fixed-dose combination (FDC) of the long-acting muscarinic antagonist tiotropium and the long-acting β2-agonist olodaterol in patients with chronic obstructive pulmonary disease.
Methods: This was a randomised, double-blind, placebo-controlled, Phase III trial with an incomplete crossover design. Patients received four of the following six treatment options for 6 weeks each: placebo, olodaterol 5 μg, tiotropium 2.5 μg, tiotropium 5 μg, tiotropium + olodaterol FDC 2.5/5 μg and tiotropium + olodaterol FDC 5/5 μg, all delivered via the Respimat(®) inhaler. The primary end point was forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 24 h (AUC0-24) response after 6 weeks of treatment; key secondary end points were FEV1 AUC from 0 to 12 h and AUC from 12 to 24 h, and further end points included lung-volume parameters measured using body plethysmography (subset of patients), measures of peak and trough FEV1, and incidence of adverse events.
Results: A significant improvement in FEV1 AUC0-24 response was observed with tiotropium + olodaterol 5/5 μg and 2.5/5 μg versus placebo and monotherapies after 6 weeks of treatment; mean response with tiotropium + olodaterol 5/5 μg versus placebo was 0.280 L (p < 0.0001). Differences to monotherapies with tiotropium + olodaterol 5/5 μg were 0.115 L versus olodaterol 5 μg, 0.127 L versus tiotropium 2.5 μg and 0.110 L versus tiotropium 5 μg (p < 0.0001 for all comparisons). Secondary end points supported these data. No safety concerns were identified.
Conclusions: Overall, this study demonstrated improvements in lung function over 24 h with an FDC of tiotropium + olodaterol over tiotropium or olodaterol alone, with no observed difference in tolerability. ClinicalTrials.gov number: NCT01559116.
(Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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