000061960 001__ 61960
000061960 005__ 20190709135432.0
000061960 0247_ $$2doi$$a10.1186/s12931-017-0622-x
000061960 0248_ $$2sideral$$a100824
000061960 037__ $$aART-2017-100824
000061960 041__ $$aeng
000061960 100__ $$aVogelmeier, Claus F.
000061960 245__ $$aEfficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial
000061960 260__ $$c2017
000061960 5060_ $$aAccess copy available to the general public$$fUnrestricted
000061960 5203_ $$aBackground: Dual bronchodilation combining a long-acting ß2-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 (FEV1; treatment difference, ¿ = +71 mL) and transition dyspnoea index (TDI; [¿ = 1.09 units]), and to LABA or LAMA on trough FEV1 (¿ = +101 mL) and a TDI (¿ = 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.
000061960 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/
000061960 590__ $$a3.751$$b2017
000061960 591__ $$aRESPIRATORY SYSTEM$$b16 / 59 = 0.271$$c2017$$dQ2$$eT1
000061960 592__ $$a1.644$$b2017
000061960 593__ $$aPulmonary and Respiratory Medicine$$c2017$$dQ1
000061960 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000061960 700__ $$aGaga, Mina
000061960 700__ $$aAalamian-Mattheis, Maryam
000061960 700__ $$aGreulich, Timm
000061960 700__ $$0(orcid)0000-0001-9096-2294$$aMarin, Jose M.$$uUniversidad de Zaragoza
000061960 700__ $$aCastellani, Walter
000061960 700__ $$aNinane, Vincent
000061960 700__ $$aLane, Stephen
000061960 700__ $$aNunez, Xavier
000061960 700__ $$aPatalano, Francesco
000061960 700__ $$aClemens, Andreas
000061960 700__ $$aKostikas, Konstantinos
000061960 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina
000061960 773__ $$g18, 140 (2017), [9 pp]$$pRespir. res.$$tRESPIRATORY RESEARCH$$x1465-9921
000061960 8564_ $$s675418$$uhttps://zaguan.unizar.es/record/61960/files/texto_completo.pdf$$yVersión publicada
000061960 8564_ $$s88878$$uhttps://zaguan.unizar.es/record/61960/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000061960 909CO $$ooai:zaguan.unizar.es:61960$$particulos$$pdriver
000061960 951__ $$a2019-07-09-11:32:19
000061960 980__ $$aARTICLE