Efficacy and safety of fluticasone furoate/vilanterol (50/25 mcg; 100/25 mcg; 200/25 mcg) in Asian patients with chronic obstructive pulmonary disease: a randomized placebo-controlled trial

Zheng, Jinping; Guia, Teresita De; Wang‐Jairaj, Jie; Newlands, Amy; Wang, Changzheng; Crim, Courtney; Zhong, Nanshan

doi:10.1185/03007995.2015.1036016

Cited by 21 publications

(14 citation statements)

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“…As previously reported, the safety profile of FF/UMEC/VI in the original IMPACT trial was in line with the profile of each of the individual components and that of the dual combinations FF/VI and UMEC/VI [19,20]. This sub-analysis in the China cohort identified no new safety signals compared with the ITT population, with similar incidences of overall AEs, drug-related AEs, and SAEs across the three treatment groups.…”

Section: Discussionsupporting

confidence: 84%

Single Inhaler Triple Therapy (FF/UMEC/VI) Versus FF/VI and UMEC/VI in Patients with COPD: Subgroup Analysis of the China Cohort in the IMPACT Trial

Zheng

Zhong

Wang

et al. 2019

Preprint

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Background In the Phase III InforMing the PAthway of COPD Treatment (IMPACT) trial, fluticasone furoate [FF]/umeclidinium [UMEC]/vilanterol [VI] single-inhaler triple therapy resulted in lower rates of moderate/severe exacerbations than dual therapy with FF/VI or UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Here we present the result in the subpopulation of patients enrolled in China. Methods The IMPACT trial was a 52-week, randomized, double-blind, parallel-group, multicenter trial. Patients (≥40 years of age) with COPD and ≥1 moderate/severe exacerbations in the prior year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25 µg, FF/VI 100/25 µg, or UMEC/VI 62.5/25 µg administered via the Ellipta inhaler. Endpoints, assessed in the overall intent-to-treat (ITT) population and in patients from China, included annual rates of exacerbations, time-to-first on-treatment moderate/severe exacerbation, and change from baseline in trough forced expiratory volume in 1 second (FEV1) at Week 52. Results Of the 10,355 patients randomized, 535 (5.2%) were from China. In the China cohort, the rate of on-treatment moderate/severe exacerbations was 0.81 per year with FF/UMEC/VI versus 0.96 with FF/VI (rate ratio [RR]: 0.84; 95% confidence interval [CI]: 0.64, 1.11; p=0.227) and 0.80 with UMEC/VI (RR: 1.02; 95% CI: 0.72, 1.44; p=0.929). Hazard ratio for time-to-first moderate/severe exacerbation was 0.84 (95% CI: 0.63, 1.11; p=0.218) for FF/UMEC/VI versus FF/VI, and 0.89 (95% CI: 0.62, 1.27; p=0.516) for FF/UMEC/VI versus UMEC/VI. Improvements in mean change from baseline in trough FEV1 were observed for FF/UMEC/VI versus FF/VI (treatment difference 137 mL; 95% CI: 86, 188; p<0.001) and FF/UMEC/VI versus UMEC/VI (treatment difference 63 mL; 95% CI: 0, 125; p=0.0.050) in China. Health status was also improved with FF/UMEC/VI versus both dual therapies. Broadly, these results were in the same direction as those seen in the overall ITT population. No new safety signals were identified. Conclusions In the China cohort of the IMPACT trial, single-inhaler triple therapy with FF/UMEC/VI versus dual therapy with FF/VI or UMEC/VI reduced the rate and risk of exacerbations, and improved lung function and quality of life similar to the overall ITT population. Trial registration: NCT02164513 (GSK study number CTT116855).

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Section: Discussionsupporting

confidence: 84%

Single Inhaler Triple Therapy (FF/UMEC/VI) Versus FF/VI and UMEC/VI in Patients with COPD: Subgroup Analysis of the China Cohort in the IMPACT Trial

Zheng

Zhong

Wang

et al. 2019

Preprint

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“…In 31 studies, 5 studies resulted in cardiac arrhythmias, 2 in atrial fibrillation, 3 in cardiac failure, 3 in cardiac ischemia, 1 in acute myocardial infarction, 1 in angina pectoris, 1 in coronary artery stenosis, 1 in acute coronary syndrome, 2 in hypertension, and 15 in cardiovascular death. Inhaled fluticasone was evaluated in 26 trials [ 3 , 16 , 17 , 22 – 44 ], inhaled budesonide in 4 trials [ 15 , 45 – 47 ], and inhaled beclomethasone in only 1 trial [ 48 ]. The range of mean age in patients was from 52.4 to 67.6.…”

Section: Resultsmentioning

confidence: 99%

“…The duration of the trials ranged from 4 to 156 weeks, with 18 trials being longer than 52 weeks in duration [ 3 , 15 , 22 – 26 , 28 , 30 , 32 , 33 , 35 , 39 , 42 , 44 , 45 , 47 ]. Most trials enrolled participants with severe COPD, as the mean predicted FEV1 of the participants was >50% in 7 trials [ 15 , 23 , 29 , 33 , 37 , 38 , 47 ] compared to ≤50% in 17 trials [ 3 , 16 , 17 , 22 , 24 , 28 , 30 – 32 , 34 , 36 , 45 , 46 , 48 ], whereas 7 trials did not report the details of FEV1.…”

Section: Resultsmentioning

confidence: 99%

“…Conversely, another study [ 16 ] suggested that FF/VI treatment resulted in increased CV effects compared with VI treatment alone. Similarly, in a study of Asian patients treated with FF/VI, high-dose FF was associated with increased CV events compared to those with low-dose FF [ 17 ].…”

Section: Discussionmentioning

confidence: 99%

“…Nevertheless, after prolonged treatment, the potential benefits of an ICS may be offset by its adverse systemic effects, such as increased extracellular volume, hypertension, glucose intolerance, and dyslipidemia, which are well-recognized risk factors for CV disease [ 11 , 12 ]. Several studies have shown that ICS treatment can alleviate CV symptoms in COPD patients [ 3 , 13 – 15 ], while other studies have suggested that ICSs lead to an increased risk of CV events [ 16 , 17 ]. Critical evaluation is required to assess whether ICS treatment can reduce or increase the risk of CV events in COPD patients.…”

Section: Introductionmentioning

confidence: 99%

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Risk of Cardiovascular Events Associated with Inhaled Corticosteroid Treatment in Patients with Chronic Obstructive Pulmonary Disease: A Meta-Analysis

Xia

2018

Canadian Respiratory Journal

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Background The cardiovascular (CV) safety of inhaled corticosteroids (ICSs) in chronic obstructive pulmonary disease (COPD) is controversial because different studies have suggested that ICSs either increase or reduce the risk of CV events in COPD patients. In this meta-analysis, we assess the CV safety of ICS therapy in COPD. Methods A meta-analysis of randomized, double-blind, parallel-group, placebo-controlled trials of ICS treatment for COPD that include at least 4 weeks of follow-up was performed. A random-effects model was used to evaluate the effects of ICS treatment on CV events. CV events were documented in each trial, and the relative risk (RR) and 95% confidence intervals (CIs) for ICSs were estimated. Results Thirty-one trials were included in this meta-analysis. The risk of CV events was not different between ICS-treated and control groups (RR: 0.99; 95% CI: 0.93 to 1.06; P=0.801). In a subgroup analysis, there were no significant differences in CV events between an ICS combined with long-acting β2 agonist (LABA) (ICS + LABA) group and an LABA-only group (RR: 1.00; 95% CI: 0.90 to 1.10; P=0.930), as well as between a combination group (ICS + LABA) and a long-acting muscarinic antagonist (LAMA) combined with LABA (LAMA + LABA) group (RR: 0.78; 95% CI: 0.39 to 1.55; P=0.473). In addition, there was no difference in the risk of CV events between ICS treatment and control groups (RR: 0.99; 95% CI: 0.90 to 1.09; P=0.872). Conclusions These results demonstrate that ICSs do not increase the risk of CV events in COPD patients.

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Open‐Label, Randomized, 6‐Way Crossover, Single‐Dose Study to Determine the Pharmacokinetics of Batefenterol (GSK961081) and Fluticasone Furoate When Administered Alone or in Combination

Ambery¹,

Riddell

Daley‐Yates³

2016

Clinical Pharm in Drug Dev

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To investigate the pharmacokinetics of inhaled batefenterol (BAT) and fluticasone furoate (FF) given alone or in combination via ELLIPTA® dry powder inhaler (DPI-E), and BAT monotherapy via DISKUS® DPI (DPI-D). In this open-label, 6-way crossover study, 48 healthy subjects were randomized to 1 of 6 treatment sequences, comprising 6 single-dose treatment regimens: (1) BAT 1200 μg via DPI-D; (2) BAT 1200 μg via DPI-E without a lactose-filled second strip; (3) BAT 1200 μg via DPI-E with a lactose-filled second strip; (4) BAT/FF 1200/300 μg via DPI-E; (5) FF 300 μg via DPI-E with a lactose-filled second strip; and (6) BAT/FF 900/300 μg via DPI-E. Pharmacokinetic data were analyzed using noncompartmental methods. Plasma BAT area under the curve (AUC) and maximum plasma concentration (Cmax ) were similar for all treatments containing BAT 1200 μg (geometric least-squares means [GLSM] ratio, 0.90-1.06). Plasma FF AUC and Cmax were reduced following BAT/FF 1200/300 μg and 900/300 μg versus FF 300 μg monotherapy (GLSM ratio, 0.62-0.77). BAT 1200 μg administered via DPI-E, alone or in combination with FF, resulted in similar systemic exposure versus BAT administered by DPI-D. FF exposure was reduced when administered in combination with BAT compared with FF alone.

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Efficacy and safety of fluticasone furoate/vilanterol (50/25 mcg; 100/25 mcg; 200/25 mcg) in Asian patients with chronic obstructive pulmonary disease: a randomized placebo-controlled trial

Abstract: NCT01376245.

Cited by 21 publications

References 15 publications

Single Inhaler Triple Therapy (FF/UMEC/VI) Versus FF/VI and UMEC/VI in Patients with COPD: Subgroup Analysis of the China Cohort in the IMPACT Trial

Single Inhaler Triple Therapy (FF/UMEC/VI) Versus FF/VI and UMEC/VI in Patients with COPD: Subgroup Analysis of the China Cohort in the IMPACT Trial

Risk of Cardiovascular Events Associated with Inhaled Corticosteroid Treatment in Patients with Chronic Obstructive Pulmonary Disease: A Meta-Analysis

Open‐Label, Randomized, 6‐Way Crossover, Single‐Dose Study to Determine the Pharmacokinetics of Batefenterol (GSK961081) and Fluticasone Furoate When Administered Alone or in Combination

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