Triple therapy with budesonide/glycopyrrolate/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, multicentre, phase 3 randomised controlled trial.
Autor: | Ferguson GT; Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA. Electronic address: garytferguson@msn.com., Rabe KF; LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Germany., Martinez FJ; Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, NY, USA., Fabbri LM; Sahlgrenska University Hospital, Gothenburg, Sweden; Department of Medicine, University Hospital, Ferrara, Italy., Wang C; National Clinical Research Centre for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China., Ichinose M; Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan., Bourne E; Pearl-a member of the AstraZeneca Group, Durham, NC, USA., Ballal S; Pearl-a member of the AstraZeneca Group, Morristown, NJ, USA., Darken P; Pearl-a member of the AstraZeneca Group, Morristown, NJ, USA., DeAngelis K; Pearl-a member of the AstraZeneca Group, Durham, NC, USA., Aurivillius M; AstraZeneca Gothenburg, Mölndal, Sweden., Dorinsky P; Pearl-a member of the AstraZeneca Group, Durham, NC, USA., Reisner C; Pearl-a member of the AstraZeneca Group, Morristown, NJ, USA; AstraZeneca, Gaithersburg, MD, USA. |
---|---|
Jazyk: | angličtina |
Zdroj: | The Lancet. Respiratory medicine [Lancet Respir Med] 2018 Oct; Vol. 6 (10), pp. 747-758. Date of Electronic Publication: 2018 Sep 16. |
DOI: | 10.1016/S2213-2600(18)30327-8 |
Abstrakt: | Background: Inhaled corticosteroids have been used in patients with chronic obstructive pulmonary disease (COPD), but the potential benefits of their use in triple therapy are not well known. We aimed to compare the efficacy of a triple therapy with corresponding dual therapies in symptomatic patients with moderate to very severe COPD, without a requirement for a history of exacerbations. Methods: In this double-blind, parallel-group, multicentre phase 3 randomised controlled trial, we recruited patients from hospitals and care centres in Canada, China, Japan, and the USA. Eligible patients were 40-80 years of age, were current or former smokers (with a smoking history of ≥10 pack-years), had an established clinical history of COPD, and were symptomatic for COPD, despite receiving two or more inhaled maintenance therapies for at least 6 weeks before screening. We randomly assigned patients (2:2:1:1) using an interactive web response system to receive budesonide/glycopyrrolate/formoterol fumarate metered-dose inhaler 320/18/9·6 μg (BGF MDI), glycopyrrolate/ formoterol fumarate metered-dose inhaler 18/9·6 μg (GFF MDI), budesonide/formoterol fumarate metered-dose inhaler 320/9·6 μg (BFF MDI), or open-label budesonide/formoterol fumarate dry-powder inhaler 400/12 μg (BUD/ FORM DPI). Primary endpoints for the Europe/Canada statistical analysis approach were FEV Findings: Between Aug 20, 2015, and Jan 5, 2018, 3047 patients were screened from 215 sites, and 1902 were randomly assigned to receive BGF MDI (n=640), GFF MDI (n=627), BFF MDI (n=316), or BUD/FORM DPI (n=319). Over 24 weeks, BGF MDI significantly improved FEV Interpretation: BGF MDI was efficacious, well tolerated, and could be a more appropriate treatment than the corresponding dual therapies for symptomatic patients with moderate to very severe COPD, irrespective of exacerbation history. Funding: Pearl-a member of the AstraZeneca Group. (Copyright © 2018 Elsevier Ltd. All rights reserved.) |
Databáze: | MEDLINE |
Externí odkaz: |