Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study

Wedzicha, Jadwiga A.; Decramer, Marc; Ficker, Joachim H.; Niewoehner, Dennis E.; Sandström, Thomas; Taylor, Angel Fowler; D’Andrea, Peter; Arrasate, Christie; Chen, Hungta; Banerji, Donald

doi:10.1016/s2213-2600(13)70052-3

Cited by 495 publications

(516 citation statements)

References 42 publications

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“…QVA149 significantly reduced the rate of moderate or severe exacerbations versus glycopyrronium by 12%, the primary outcome of the study ( fig. 4) [84]. The rate of all (mild, moderate and severe) exacerbations was also significantly reduced with QVA149 versus glycopyrronium (15%) and open label tiotropium (14%) [84].…”

Section: Glycopyrroniummentioning

confidence: 94%

“…4) [84]. The rate of all (mild, moderate and severe) exacerbations was also significantly reduced with QVA149 versus glycopyrronium (15%) and open label tiotropium (14%) [84]. In addition to providing benefits in terms of exacerbation rate, QVA149 significantly improved trough FEV1, health status, patient symptom scores (including the percentage of nights with no night-time awakenings, percentage of days with no daytime symptoms and daily total symptom score), daily rescue medication use and the percentage of days without use of rescue medication compared with glycopyrronium and open label tiotropium [84][85][86].…”

Section: Glycopyrroniummentioning

confidence: 99%

“…No new safety issues were identified with QVA149 compared with its mono-components in the IGNITE trials, and the overall adverse event profile of QVA149 was noted to be similar to that of placebo and of the active comparators glycopyrronium, indacaterol, tiotropium and SFC [84,87,88].…”

Section: Glycopyrroniummentioning

confidence: 99%

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Addressing unmet needs in the treatment of COPD

Patalano¹,

Banerji²,

D’Andrea³

et al. 2014

Eur Respir Rev

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The burden of chronic obstructive pulmonary disease (COPD) is considerable, both socially and economically. Central to COPD management is the use of long-acting bronchodilators, which provide patients with optimal bronchodilation and improvements in symptoms. The once-daily, long-acting b 2 -agonist indacaterol, the long-acting muscarinic antagonist glycopyrronium, and the indacaterol/glycopyrronium fixed-dose combination QVA149 have all been shown to significantly improve lung function and patientreported outcomes. The ability to take medication appropriately is important. Easy to use, low resistance devices may help patients take their medication and achieve good drug deposition. There is a need to optimise COPD management by treating the right patients with the right therapy at the right time during the course of their disease. Herein, we present a view on the current COPD management landscape and current unmet needs, and look to the future of COPD treatment and how patient care can be optimised. @ERSpublications There is a need to optimise COPD treatment, with the aim of improving patients' lives

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Section: Glycopyrroniummentioning

confidence: 94%

Section: Glycopyrroniummentioning

confidence: 99%

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Addressing unmet needs in the treatment of COPD

Patalano¹,

Banerji²,

D’Andrea³

et al. 2014

Eur Respir Rev

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“…[7][8][9] Adicionalmente, evidências de estudos prospectivos tem demonstrado significante melhora na função pulmonar da combinação em dose fixa LABA/LAMA comparada aos seus monocomponentes ou a outro LAMA. [10][11][12] Recentemente, os LABAs de ação ultralonga (ultra-LABAs) com ação terapêutica de 24 horas foram lançados no mercado brasileiro. O primeiro aprovado para o tratamento da DPOC foi o indacaterol, que demonstrou reduzir a hiperinsuflação pulmonar em comparação ao tiotrópio, apesar de ambos serem capazes de aumentar o volume expiratório forçado no primeiro segundo (VEF 1 ) dos pacientes.…”

Section: Introductionunclassified

Efeito agudo do indacaterol mais tiotrópio versus formoterol mais tiotrópio sobre hiperinsuflação pulmonar (Estudo EFINTH) na DPOC: protocolo de estudo para um ensaio randomizado

2016

JAFF

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Resumo:Introdução: Apesar da larga disponibilidade de β 2-agonistas de longa ação e anticolinérgicos de longa ação, isolados ou em combinações em doses fixas, para tratamento de manutenção da doença pulmonar obstrutiva crônica (DPOC), dados de ensaios clínicos de comparação direta de diferentes esquemas de terapias duplas são escassos. O indacaterol é β 2-agonista de ação ultra-longa recentemente lançado no mercado brasileiro que demonstrou reduzir significativamente a hiperinsuflação pulmonar em portadores de DPOC. Objetivo: Avaliar o efeito agudo do indacaterol (150 mcg) mais tiotrópio (5 mcg) versus formoterol (12 mcg) mais tiotrópio (5 mcg) sobre a hiperinsuflação pulmonar (Estudo EFINTH) em pacientes com DPOC. Métodos: Ensaio clínico randomizado, exploratório, aberto, fase IV, cruzado, de 2 períodos. Um total de 30 portadores de DPOC moderada a grave, sintomáticos, serão recrutados em um Ambulatório de Referência, em Salvador, Bahia. A espirometria e os volumes pulmonares serão mensurados antes e após 5, 30, 60, 120 e 240 min a administração dos esquemas de terapia dupla. O desfecho primário é o pico da capacidade inspiratória (CI). A área sobre a curva em 4 h para CI, volume expiratório forçado no primeiro segundo (VEF 1 ) e capacidade vital forçada (CVF) serão os desfechos secundários. Conclusões: Este estudo pretende explorar o efeito de dois esquemas de terapia dupla sobre a redução da CI em pacientes com DPOC e, dessa forma, fornecer dados para a concepção e implementação de estudos de eficácia em larga escala e em longo prazo.Palavras-chave: DPOC; broncodilatadores; hiperinsuflação pulmonar; indacaterol; tiotrópio; formoterol. Abstract: Introduction:Despite the wide availability of long-acting beta2-agonists and long-acting anticholinergics, isolated or in fixed-dose combinations, for maintenance treatment of chronic obstructive pulmonary disease (COPD), data of head-to--head comparative trial of different regimens of dual therapies are scarce. Indacaterol is a ultra-long-acting beta2-agonist recently launched in the Brazilian market that has been shown to significantly reduce the lung hyperinflation in COPD patients. Objective: To evaluate acute effect of indacaterol (150 mcg) plus tiotropium (5 mcg) versus formoterol (12 mcg) plus tiotropium (5 mcg) on lung hyperinflation (EFINTH study) in patients with COPD. Methods: Randomized, open-label, phase IV, 2-periods, crossover trial. A total of 30 patients with moderate-to-severe COPD, symptomatic, will be recruited at a Reference Outpatient Clinic in Salvador, state of Bahia, Brazil. Spirometry and lung volumes were measured before and 5, 30, 60, 120 and 240 min after administration of dual therapy regimens. The primary outcome of this study is peak inspiratory capacity (IC). The area on the 4-h curve for IC, 1-s forced expiratory volume (FEV 1 ) and forced vital capacity (FVC). Conclusions: This study aims to explore the effect of two dual therapy regimens on reduction of lung hyperinflation in patients with COPD and, thus, provides data for design and...

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“…Indeed, I got it wrong: the drug industry (as well as clinical researchers and expert committees) has spent (wasted?) over 20 years with the question of searching for often marginal differences in outcomes with ''optimal'' treatment regimes comparing one, two or three single or combined (pharmacologically old) components, often following their canonical imperatives of ''maximized'' bronchodilation versus ICS-containing combos: LAMA versus ICS/LABA [10], ICS/LABA versus LABA [11], LABA/LAMA versus LAMA [12,13], LABA/LAMA versus ICS/LABA [6], plus a number of studies circling around the question if it was possible to withdraw ICS safely or not [7,8,14]. Tellingly, the only study that ignored the ''one-or-another'' agenda and looked at the effects of combining all three (ICS/LABA plus LAMA) compounds together (the Canadian OPTIMA trial) [15], mimicking usual practice of clinicians, particular in more severe forms of COPD, was non-industry sponsored.…”

mentioning

confidence: 99%

And Then There Were Three: Time to Move Onward in COPD Drug Development Beyond LAMA/LABA/ICS at Last?

Beeh

2018

Pulm Ther

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Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study

Cited by 495 publications

References 42 publications

Addressing unmet needs in the treatment of COPD

Addressing unmet needs in the treatment of COPD

Efeito agudo do indacaterol mais tiotrópio versus formoterol mais tiotrópio sobre hiperinsuflação pulmonar (Estudo EFINTH) na DPOC: protocolo de estudo para um ensaio randomizado

And Then There Were Three: Time to Move Onward in COPD Drug Development Beyond LAMA/LABA/ICS at Last?

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