Bronchodilator effects of indacaterol and formoterol in patients with COPD

Beier, Jutta; Beeh, Kai Michael; Brookman, L.; Peachey, Guy; Hmissi, Abdel; Pascoe, Steven

doi:10.1016/j.pupt.2009.05.001

Cited by 47 publications

(33 citation statements)

References 18 publications

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“…This improvement in dyspnoea (TDI) was accompanied by an improvement of 182 mL in resting IC after 14 days of treatment with indacaterol compared with placebo, together with significant improvement (p < 0.05) in trough FEV 1 of 145 mL. These results are consistent with a previous study that showed that a single dose of indacaterol demonstrated greater improvements in both resting IC and FEV 1 compared with twice daily formoterol(5), and confirm the 24-h bronchodilator efficacy of indacaterol in patients with COPD. Likewise, in the indacaterol treatment groups, there were improvements in a range of volume measures including FVC, VC and RV.…”

supporting

confidence: 90%

“…In previous studies, indacaterol has demonstrated 24-h bronchodilation (3)(4), with no loss in efficacy on once daily dosing for up to a year (4), and a good overall safety profile (4). Further, in a previous study, a single 300 µg dose of indacaterol had a greater effect on resting IC than formoterol 12 µg administered twice daily (5). The aim of the present study was to evaluate the effect of indacaterol on dynamic and static lung hyperinflation, breathlessness, and health status in patients with moderate-to-severe COPD.…”

Section: Chronic Obstructive Pulmonary Disease (Copd) Is a Chronic Prmentioning

confidence: 79%

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Effect of Indacaterol on Dynamic Lung Hyperinflation and Breathlessness in Hyperinflated Patients with COPD

Beeh¹,

Wagner²,

Khindri³

et al. 2011

COPD: Journal of Chronic Obstructive Pulmonary Disease

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Indacaterol is a novel, inhaled once-daily ultra long-acting β2-agonist for the treatment of COPD. This randomised, double-blind, placebo-controlled, two-period crossover study evaluated the effect of two-week treatment with indacaterol 300 μg on peak and isotime exercise inspiratory capacity (IC) in patients with COPD. Patients (40-80 years) with post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) < 70%, percent predicted FEV1 ≥ 40% and ≤ 80%, smoking history ≥ 20 pack-years and functional residual capacity > 120% of predicted normal were randomised to receive indacaterol 300 μg or placebo once-daily via a single-dose dry powder inhaler. Following 14 days of treatment, IC at peak and isotime during constant-load (80% of maximum workload) cycle ergometry was analysed using linear mixed-effects models. Safety and tolerability were also monitored. Twenty-seven patients (67% male; mean age, 61.3 years) were randomised; 24 completed the study. On Day 14, indacaterol showed statistically significant improvements over placebo in peak (317 mL [95% CI: 118-517]; p < 0.01) and isotime IC (268 mL [95% CI: 104-432]; p < 0.01). Statistically significant improvements were observed with indacaterol versus placebo on Day 14 for the following secondary endpoints: resting IC, trough FEV1, dyspnoea (BDI/TDI and Borg CR10 scale at isotime) and exercise endurance time. Indacaterol was well tolerated, with no serious adverse events or deaths. In conclusion, indacaterol 300 μg administered once-daily showed a clinically relevant increase in IC after 14 days of treatment, reflecting a reduction in dynamic hyperinflation.

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supporting

confidence: 90%

Section: Chronic Obstructive Pulmonary Disease (Copd) Is a Chronic Prmentioning

confidence: 79%

Effect of Indacaterol on Dynamic Lung Hyperinflation and Breathlessness in Hyperinflated Patients with COPD

Beeh¹,

Wagner²,

Khindri³

et al. 2011

COPD: Journal of Chronic Obstructive Pulmonary Disease

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“…Five randomised studies were performed in COPD patients Aerolizer ® inhaler) [37]. Indacaterol had a greater effect on peak inspiratory capacity (p ¼ 0.034); cough occurred more frequently following indacaterol administered using the Breezhaler ® device.…”

Section: Nexthaler ® Vs Pmdimentioning

confidence: 99%

New developments in inhaler devices within pharmaceutical companies: A systematic review of the impact on clinical outcomes and patient preferences

Ninane

Vandevoorde²,

Cataldo

et al. 2015

Respiratory Medicine

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“…13 Beier et al também demonstrou que, embora ambos apresentassem efeitos similares sobre o VEF 1 , o indacaterol foi superior ao obter aumento significativo na capacidade inspiratória (CI) comparada à dose recomendada de formoterol. 14 Estudos comparando a eficácia broncodilatadora do indacaterol com o tiotrópio demonstraram superioridade em relação à monoterapia. O estudo de Mahler et al identificou que a associação de tiotrópio e indacaterol promovia aumento da CI e melhor broncodilatação em relação à monoterapia com tiotrópio.…”

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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Bronchodilator effects of indacaterol and formoterol in patients with COPD

Abstract: Background Resting inspiratory capacity (IC) reflects static hyperinflation in chronic

Cited by 47 publications

References 18 publications

Effect of Indacaterol on Dynamic Lung Hyperinflation and Breathlessness in Hyperinflated Patients with COPD

Effect of Indacaterol on Dynamic Lung Hyperinflation and Breathlessness in Hyperinflated Patients with COPD

New developments in inhaler devices within pharmaceutical companies: A systematic review of the impact on clinical outcomes and patient preferences

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

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