Triple therapy in COPD: new evidence with the extrafine fixed combination of beclomethasone dipropionate, formoterol fumarate, and glycopyrronium bromide

Singh, Dave; Corradi, Massimo; Spinola, Monica; Papi, Alberto; Usmani, Omar; Scuri, Mario; Petruzzelli, Stefano; Vestbo, Jørgen

doi:10.2147/copd.s146822

Cited by 33 publications

(29 citation statements)

References 40 publications

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“…1 An important finding of this analysis is that there seems to be a treatment benefit with “free,” “open-triple,” or combination therapy in the population studied. The results from the Phase III GOLDEN studies, specifically improvements in lung function and health status, are in agreement with previously reported efficacy of triple therapies 9 , 17 – 19 and add to the growing body of evidence regarding the potential role of triple therapy in the clinical management of COPD. We expect the place of triple LAMA/LABA/ICS therapy within the treatment algorithm to be more clearly defined in future updates of the GOLD Report.…”

Section: Discussionsupporting

confidence: 87%

“…The majority of subjects on background LABA therapy were also using ICS (range: 84%–95%), representing the subset of subjects more likely to have severe disease and airflow limitation, and with the addition of nebulized LAMA, these subjects were effectively using an open LAMA/LABA/ICS triple therapy. Recent studies have demonstrated that triple therapy plays a role in the COPD therapeutic landscape, 9 , 17 , 18 and it is a recommended treatment option for patients who experience recurrent exacerbations or continuing symptoms despite current treatment with either LAMA/LABA or LABA/ICS combination. 1 An important finding of this analysis is that there seems to be a treatment benefit with “free,” “open-triple,” or combination therapy in the population studied.…”

Section: Discussionmentioning

confidence: 99%

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Effect of background long-acting beta<sub>2</sub>-agonist therapy on the efficacy and safety of a novel, nebulized glycopyrrolate in subjects with moderate-to-very-severe COPD

Kerwin¹,

Tosiello²,

Price³

et al. 2018

COPD

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BackgroundPhase III studies demonstrated efficacy and safety of nebulized glycopyrrolate inhalation solution (GLY) in subjects with COPD. Secondary analyses were performed to examine the effect of background long-acting beta2-agonist (LABA) use on the efficacy and safety of nebulized GLY.MethodsIn two 12-week placebo-controlled studies (GOLDEN 3 and GOLDEN 4) and one 48-week, open-label active-controlled study (GOLDEN 5), a total of 2,379 subjects were stratified by background LABA use (LABA-yes: n=861; LABA-no: n=1,518) and randomized to placebo vs GLY 25 or 50 µg twice daily, or GLY 50 µg twice daily vs tiotropium (TIO) 18 µg once daily. Lung function, patient-reported outcomes, exacerbations, and safety were assessed.ResultsCompared with placebo, pooled data from the 12-week studies showed significant improvements from baseline with GLY 25 and 50 µg across LABA subgroups in trough FEV1 (LABA-yes: 0.101 and 0.110 L; LABA-no: 0.092 and 0.101 L, respectively; P<0.001) and St George’s Respiratory Questionnaire total score (SGRQ; LABA-yes: −2.957 and −3.888; LABA-no: −3.301 and −2.073, respectively; P<0.05). Incidence of treatment-emergent adverse events (TEAEs) was similar in LABA subgroups, and lower in GLY 25 µg vs placebo. In the 48-week active-controlled study, GLY and TIO both showed improvement from baseline across LABA subgroups in FEV1 (LABA-yes: 0.106 and 0.092 L; LABA-no: 0.096 and 0.096 L, respectively) and in SGRQ total score (LABA-yes: −5.190 and −3.094; LABA-no: −4.368 and −4.821, respectively). Incidence of TEAEs was similar between GLY and TIO, and across LABA subgroups. Exacerbation rates were similar across treatments and LABA subgroups, and cardiovascular events of special interest were more frequent in the LABA-no subgroup. Nebulized GLY, combined with LABA, did not generate any additional safety signals.ConclusionNebulized GLY demonstrated efficacy and was well tolerated up to 48 weeks in subjects with COPD with/without background LABA.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Effect of background long-acting beta<sub>2</sub>-agonist therapy on the efficacy and safety of a novel, nebulized glycopyrrolate in subjects with moderate-to-very-severe COPD

Kerwin¹,

Tosiello²,

Price³

et al. 2018

COPD

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“…When The efficacy of triple therapy delivered by 2 inhalers or a single inhaler has been reported in several studies; 51,[64][65][66][67][68] however, single-inhaler therapy is generally preferable to avoid inhalation errors and improve adherence. 69 Table 2 summarizes clinical trial evidence for ICS-based therapy in patients with COPD. In 2 clinical trials, fluticasone 1 umeclidinium 1 vilanterol significantly improved lung function and QoL compared with placebo 1 fluticasone 1 vilanterol in patients with COPD.…”

Section: Eosinophils As Markers Of Response To Icsmentioning

confidence: 99%

Inhaled Corticosteroid Treatment in Chronic Obstructive Pulmonary Disease (COPD): Boon or Bane?

Kaplan

2020

J Am Board Fam Med

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Inhaled corticosteroid (ICS)-based therapy is often used for patients with chronic obstructive pulmonary disease (COPD). However, this approach is under scrutiny because of ICS overuse in patients for whom it is not recommended and because of concerns about adverse events, particularly pneumonia, with long-term ICS use. Evidence suggests ICS may be beneficial in specific patients, namely, those with high blood eosinophil counts (eg, ≥300 cells/mL) or who are at a high risk of exacerbations. According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2020 ABCD assessment tool, these patients belong in group D. For these patients, recommended initial treatment includes ICS in combination with long-acting b 2-agonists (LABAs) when blood eosinophil counts are ≥300 cells/mL or LABA 1 long-acting muscarinic antagonist (LAMA) when patients are highly symptomatic, that is, with greater dyspnea and/or exercise limitation. Follow-up treatments for patients with persistent dyspnea and/or exacerbations may include LABA 1 ICS, LABA 1 LAMA, or LABA 1 LAMA 1 ICS, with use of ICS being guided by blood eosinophil counts. In this review, differences in the inflammatory mechanism underlying COPD and asthma and the role of ICS treatment in COPD are summarized. Furthermore, findings from recent clinical trials where use of ICS-based dual or triple therapy in COPD was compared with LABA 1 LAMA therapy and trials in which ICS withdrawal was evaluated in patients with COPD are reviewed. Finally, a step-by-step guide for ICS withdrawal in patients who are unlikely to benefit from this treatment is proposed. A video of the author discussing the overall takeaway of the review article could be downloaded from the link provided: https://www.youtube.com/watch?v=Uq7Sr5jqPDI.

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“…14,17 Both were noninferiority trials. In the study carried out by Bremner and colleagues 17 14,23 Open triple versus open triple therapies Only two recent studies have evaluated two different open triple therapies showing no differences in terms of lung function, health status, rescue medication, daily activities, and exacerbations. 24,25…”

Section: Fdc Triple Therapy Versus Open Triple Therapymentioning

confidence: 99%

Triple therapy for COPD: a crude analysis from a systematic review of the evidence

Lόpez-Campos

Carrasco‐Hernández

Quintana‐Gallego

et al. 2019

Ther Adv Respir Dis

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We systematically reviewed the current knowledge on fixed-dose triple therapies for the treatment of chronic obstructive pulmonary disease (COPD), with a specific focus on its efficacy versus single bronchodilation, double fixed dose combinations, and open triple therapies. Articles were retrieved from PubMed, Embase, and Scopus up to 3 August 2018. We selected articles with randomized controlled or crossover design conducted in patients with COPD and published as full-length articles or scientific letters, evaluating triple therapy combinations in a single or different inhaler, and with efficacy data versus monocomponents, double combinations, or open triple therapies. Our systematic search reported 108 articles, of which 24 trials were finally selected for the analysis. A total of 7 studies with fixed dose triple therapy combinations, and 17 studies with open triple therapies combinations. Triple therapy showed improvements in lung function [trough forced expiratory volume (FEV1) ranging from not significant (NS) to 147 ml], health status using the St. George’s Respiratory Questionnaire [(SGRQ) from NS to 8.8 points], and exacerbations [risk ratio (RR) from NS to 0.59 for all exacerbations] versus single or double therapies with a variability in the response, depending the specific combination, and the comparison group. The proportion of adverse effects was similar between study groups, the exception being the increase in pneumonia for some inhaled corticosteroid (ICS) containing groups. The reviews of this paper are available via the supplementary material section.

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Triple therapy in COPD: new evidence with the extrafine fixed combination of beclomethasone dipropionate, formoterol fumarate, and glycopyrronium bromide

Cited by 33 publications

References 40 publications

Effect of background long-acting beta<sub>2</sub>-agonist therapy on the efficacy and safety of a novel, nebulized glycopyrrolate in subjects with moderate-to-very-severe COPD

Effect of background long-acting beta<sub>2</sub>-agonist therapy on the efficacy and safety of a novel, nebulized glycopyrrolate in subjects with moderate-to-very-severe COPD

Inhaled Corticosteroid Treatment in Chronic Obstructive Pulmonary Disease (COPD): Boon or Bane?

Triple therapy for COPD: a crude analysis from a systematic review of the evidence

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