Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial

Respiratory Research

Research

Mina Gaga¹  Stephen Lane²  Vincent Ninane³  Claus F. Vogelmeier⁴  Timm Greulich⁴  Walter Castellani⁵  Maryam Aalamian-Mattheis⁶  Konstantinos Kostikas⁶  Francesco Patalano⁶  Andreas Clemens⁶  Jose M. Marin⁷  Xavier Nunez⁸ 

[1] 7th Respiratory Medicine Department, Athens Chest Hospital Sotiria, Athens, Greece;Adelaide & Meath Hospital, Dublin, Ireland;CHU Saint-Pierre - Service de Pneumologie, Brussells, Belgium;Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Centre Giessen and Marburg, Philipps-Universität Marburg, Member of the German Centre for Lung Research (DZL), Marburg, Germany;Department of Respiratory Physiopathology, Palagi Hospital, Florence, Italy;Novartis Pharma AG, Basel, Switzerland;Respiratory Medicine, Hospital Universitario Miguel Servet, Zaragoza, Spain;Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain;TFS Develop, Barcelona, Spain;

关键词: Chronic obstructive pulmonary disease;    Dual bronchodilation;    Indacaterol/glycopyrronium;    Direct switch;    Open-label;   

DOI  :  10.1186/s12931-017-0622-x

 received in 2017-05-17, accepted in 2017-07-07,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundDual bronchodilation combining a long-acting β2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA) is the preferred choice of treatment recommended by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 guidelines for the management of patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). The once-daily (q.d.) fixed-dose combination (FDC) of LABA, indacaterol 110 μg and LAMA, glycopyrronium 50 μg (IND/GLY 110/50 μg q.d.) demonstrated superior improvements in lung function, dyspnoea and overall health status and better tolerability against LABA or LAMA monotherapies and combination of LABA and inhaled corticosteroid (ICS) in more than 11,000 patients with moderate-to-severe COPD in several randomised controlled clinical trials.MethodsThe CRYSTAL study was the first, 12-week, randomised, open-label trial that evaluated the efficacy and safety of a direct switch from previous treatments to IND/GLY 110/50 μg q.d. on lung function and dyspnoea in patients with moderate COPD and a history of up to one exacerbation in the previous year. Patients were divided into 2 groups according to their background therapy and symptom scores and were randomised (3:1) to IND/GLY or to continue with their previous treatments.ResultsThe study included 4389 randomised patients, of whom 2160 were in groups switched to IND/GLY (intention-to-treat population). The effect of IND/GLY was superior to LABA + ICS on trough forced expiratory volume in 1 s (FEV1; treatment difference, Δ = +71 mL) and transition dyspnoea index (TDI; [Δ = 1.09 units]), and to LABA or LAMA on trough FEV1 (Δ = +101 mL) and a TDI (Δ = 1.26 units). Improvements in health status and lower rescue medication use were also observed with IND/GLY. The safety profile of the study medication was similar to that observed in previous studies.ConclusionsIND/GLY demonstrated superior improvements in lung function and dyspnoea after direct switch from previous treatments.Trial registrationClinicalTrials.gov number: NCT01985334.

【 授权许可】

CC BY   
© The Author(s). 2017