Efficacy and Safety of Direct Switch to Indacaterol/glycopyrronium in Patients with Moderate COPD: the CRYSTAL Open-label Randomised Trial

Overview

Journal Respir Res

Specialty Pulmonary Medicine

Date 2017 Jul 20

PMID 28720132

Citations 28

Authors

Claus F Vogelmeier

Mina Gaga

Maryam Aalamian-Mattheis

Timm Greulich

Jose M Marin

Walter Castellani

Vincent Ninane

Stephen Lane

Xavier Nunez

Francesco Patalano

Andreas Clemens

Konstantinos Kostikas

Affiliations

Soon will be listed here.

Abstract

Background: Dual bronchodilation combining a long-acting β-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.

Methods: The 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.

Results: The 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 (FEV; treatment difference, Δ = +71 mL) and transition dyspnoea index (TDI; [Δ = 1.09 units]), and to LABA or LAMA on trough FEV (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.

Conclusions: IND/GLY demonstrated superior improvements in lung function and dyspnoea after direct switch from previous treatments.

Trial Registration: ClinicalTrials.gov number: NCT01985334 .

Citing Articles

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Exarchos K, Hillas G, Steiropoulos P, Papanastasiou P, Gogali A, Kostikas K Clin Respir J. 2024; 18(7):e13803.

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Long-acting muscarinic antagonist (LAMA) plus long-acting beta-agonist (LABA) versus LABA plus inhaled corticosteroid (ICS) for stable chronic obstructive pulmonary disease.

Fukuda N, Horita N, Kaneko A, Goto A, Kaneko T, Ota E Cochrane Database Syst Rev. 2023; 6:CD012066.

PMID: 37276335 PMC: 10241721. DOI: 10.1002/14651858.CD012066.pub3.

Real-World Safety and Efficacy of Glycopyrronium Bromide in Japanese Patients with COPD: A 52-Week Post-Marketing Surveillance.

Kato C, Wang D, Nakamura N, Sasajima T, Yoshisue H Open Respir Med J. 2023; 16:e187430642112240.

PMID: 37273944 PMC: 10156031. DOI: 10.2174/18743064-v16-e2112240.

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