Chris Compton

Health Economics and Outcomes Research (United Kingdom)

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David A. Lipson

University of Pennsylvania

Claus Vogelmeier

German Center for Lung Research

Afisi Ismaila

McMaster University

Lee Tombs

Precise Consult International (Ethiopia)

François Maltais

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Leif Bjermer

Lund University

Edward Kerwin

Clinical Research Institute

Kieran Rothnie

Health Economics and Outcomes Research (United Kingdom)

Paul Jones

St George's, University of London

I. Boucot

Middlesex University

Cooperative Institutions

GlaxoSmithKline (United Kingdom)

GlaxoSmithKline (United States)

Health Economics and Outcomes Research (United Kingdom)

McGill University Health Centre

GlaxoSmithKline (Netherlands)

Imperial College London

University of British Columbia

Adelphi Group (United Kingdom)

McGill University

University College London

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Can Patients With COPD Achieve and Maintain Disease Stability With Single-Inhaler Triple Therapy Fluticasone Furoate/Umeclidinium/Vilanterol Versus Dual Therapy Budesonide/Formoterol: A FULFIL Post Hoc Analysis

Dave Singh Chris Compton Raj Kumar Sharma Suneal K. SREEDHARAN Lee Tombs

Fluticasone propionate

Budesonide/formoterol

Dry-powder inhaler

Mometasone furoate

10.1164/ajrccm-conference.2024.209.1_meetingabstracts.a3826

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Characteristics and treatment pathways of COPD patients initiating single-inhaler dual or triple therapy in England

05.01 - Airway pharmacology and treatment (2023)

Stephen G. Noorduyn Robert Wood Kieran Rothnie Kiran Rai Monica Seif

Introduction: Patient characteristics of new users of single-device inhalers for COPD are unknown. We describe characteristics and treatments for patients with COPD newly initiating dual or triple single-inhaler therapies in routine care in the UK. Methods: This is a retrospective cohort study using linked UK primary and secondary care data of patients with a COPD diagnosis, aged ≥35 years, with evidence of smoking history and newly initiating single-inhaler dual therapy (long-acting muscarinic antagonist [LAMA]/long-acting β2-agonist [LABA] or inhaled corticosteroid [ICS]/LABA) or single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI). Baseline characteristics and treatments are described by index therapy. Results: 32792 patients were included (FF/UMEC/VI: 14042 [42.8%], ICS/LABA: 10695 [32.6%], LAMA/LABA: 8055 [24.6%]). Table 1 shows baseline clinical characteristics and treatments immediately prior to index. Conclusions: New users of FF/UMEC/VI were more breathless, had worse lung function and more prior exacerbations at therapy initiation than new users of single-inhaler dual therapies in England. ICS/LABA and LAMA/LABA single-inhaler new users mostly stepped up from ICS and LAMA monotherapy, respectively, or were initial maintenance therapy users, whilst most FF/UMEC/VI new users switched from prior MITT use. Funding: GSK 214593 3

Lama

Fluticasone propionate

Dry-powder inhaler

Group B

B2 receptor

10.1183/13993003.congress-2023.pa2393

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Understanding the Gaps in the Reporting of COPD Exacerbations by Patients: A Review

COPD Journal of Chronic Obstructive Pulmonary Disease (2024)

Paul Jones Ashraf Alzaabi Alejandro Casas Mehmet Polatlı Marcelo Fouad Rabahi

Exacerbations of chronic obstructive pulmonary disease (COPD) are associated with loss of lung function, poor quality of life, loss of exercise capacity, risk of serious cardiovascular events, hospitalization, and death. However, patients underreport exacerbations, and evidence suggests that unreported exacerbations have similar negative health implications for patients as those that are reported. Whilst there is guidance for physicians to identify patients who are at risk of exacerbations, they do not help patients recognise and report them. Newly developed tools, such as the COPD Exacerbation Recognition Tool (CERT) have been designed to achieve this objective. This review focuses on the underreporting of COPD exacerbations by patients, the factors associated with this, the consequences of underreporting, and potential solutions.

Copd exacerbation

10.1080/15412555.2024.2316594

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Correction: Benefit of prompt initiation of single-inhaler fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) in patients with COPD in England following an exacerbation: a retrospective cohort study

Respiratory Research (2024)

Afisi Ismaila Kieran Rothnie Robert Wood Victoria Banks Lucinda J Camidge

COPD-related total costs for prompt and delayed initiators and the associated exponentiated coefficient (95% confidence interval) and p-value in Fig. 8b.

Fluticasone propionate

Copd exacerbation

Fluticasone

10.1186/s12931-024-02745-x

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Improving COPD symptoms with umeclidinium/vilanterol and impact of baseline disease severity: the EMAX trial

05.01 - Airway pharmacology and treatment (2019)

François Maltais Claus Vogelmeier I. Boucot Leif Bjermer Edward Kerwin

Background: Based on limited evidence, dual long-acting bronchodilators are recommended as stepwise treatment following monotherapy for symptomatic low exacerbation risk patients with persistent symptoms. Aims: This pre-specified secondary analysis of the Early MAXimization of bronchodilation for improving COPD stability (EMAX) trial examined if worse baseline severity favoured umeclidinium/vilanterol (UMEC/VI) vs UMEC or salmeterol (SAL). Methods: This 24-week, double-blind, parallel-group trial randomised inhaled corticosteroid (ICS)-free patients to UMEC/VI 62.5/25 µg once-daily (QD), UMEC 62.5 µg QD, or SAL 50 µg twice-daily. Transition Dyspnoea Index (TDI), Evaluating Respiratory Symptoms score (E-RS) and COPD Assessment Test (CAT) responders and Subject Global Rating of Change in COPD Severity (SGRSI) were assessed for the ITT population, GOLD 3 (FEV₁ 30–50% predicted) and CAT score ≥20 subgroups. Results: In the ITT population, the proportion of responders favoured UMEC/VI vs UMEC and SAL for all symptom outcomes; greater magnitudes of efficacy benefit were observed for TDI and SGRSI in the GOLD 3, but not the CAT ≥20, subgroups (Figure). Conclusions: In symptomatic ICS-free patients at low exacerbation risk, severity of airflow limitation may be more discriminative than CAT score for identifying patients who will benefit more from dual bronchodilation. Funding: GSK (study 201749; NCT03034915)

Group B

10.1183/13993003.congress-2019.pa2473

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Umeclidinium/vilanterol in preventing clinically important deterioration (CID) in COPD and impact of baseline disease severity: the EMAX trial

05.01 - Airway pharmacology and treatment (2019)

Claus Vogelmeier Ian Naya Lee Tombs Edward Kerwin Leif Bjermer

Background: The risk of short-term deterioration, assessed by the CID composite measure, is reduced with dual vs mono bronchodilators in inhaled corticosteroid (ICS)-free symptomatic patients with COPD. It is unclear if this protection alters with baseline severity of COPD. Aims: This pre-specified secondary analysis of the Early MAXimization of bronchodilation for improving COPD stability (EMAX) trial compared CID risk in the ITT population and in severity subgroups with a baseline GOLD spirometric grade 3 (FEV₁ 30–50% predicted) or COPD Assessment Test (CAT) score ≥20. Methods: This 24-week, double-blind, parallel-group trial randomised patients to umeclidinium/vilanterol (UMEC/VI) 62.5/25 µg QD, UMEC 62.5 µg QD, or salmeterol (SAL) 50 µg BID. Risk of a first CID was assessed using 3 definitions of CID (Figure). Results: In the ITT population and subgroups, CID risk was lower with UMEC/VI vs UMEC or SAL for all CID definitions, except in one instance (Figure). This protection was numerically higher in the GOLD 3 subgroup regardless of CID definition, but not in the CAT ≥20 subgroup. Conclusions: In symptomatic ICS-free patients at low exacerbation risk, UMEC/VI reduced CID risk vs UMEC and SAL. Compared with the ITT population, this protection was greater in patients with more severe airflow limitation but not with more symptoms. Funding: GSK (study 201749; NCT03034915)

Group B

10.1183/13993003.congress-2019.pa2475

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Use of the CAPTURE case-finding tool to identify COPD patients who may need treatment

05.02 - Monitoring airway disease (2023)

Jinping Zheng Yun Li Fuqiang Wen Qianli Ma Rongchang Chen

Background: CAPTURE was developed to identify individuals who may have COPD (Martinez et al. Am J Respir Crit Care Med. 2017;195:748). This study aimed to test its ability to identify patients with significant dyspnoea, impaired health status or at risk of exacerbations or hospitalisation. Methods: Data are from COMPASS, a prospective study of COPD in China (Liang et al. ERJ Open Res. 2021;7:00201). Patients were categorised as CAPTURE positive if they met both criteria: questionnaire score ≥2 and peak expiratory flow <250L/min (females) or <350L/min (males). Sensitivity and specificity were tested for GOLD I-IV, and patients with CAT ≥10 vs <10, mMRC ≥2 vs <2, or ≥1 moderate exacerbation or hospitalisation in the previous year vs zero. Positive and negative predicted values (PPV and NPV) were calculated. Results: COPD patients, n=1696, mean age 65.4±7.5 (SD) years, 91% males, post-bronchodilator FEV₁ 66.6±20.1 % pred were compared with 307 controls (chronic bronchitis and never smokers), mean age 60.3±7.0 years, 65% males, FEV₁/FVC 0.77±0.04. Data are tabulated; the difference between upper and lower bounds for 95% CIs was <15% in each case. Conclusion: CAPTURE has high sensitivity and specificity to detect COPD, but low sensitivity for GOLD I. Equally important for case finding, the high sensitivity and NPV estimates suggest that it may identify individuals who could benefit from treatment and those who may not. Funding GSK (208630)

Chronic bronchitis

Gold standard (test)

10.1183/13993003.congress-2023.pa3663

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Preventing clinically important deterioration with single-inhaler triple therapy in COPD

ERJ Open Research (2018)

Ian Naya Chris Compton Afisi Ismaila Ruby Birk Noushin Brealey

Clinically important deterioration (CID) is a novel composite end-point (lung function, health status, exacerbations) for assessing disease stability in patients with chronic obstructive pulmonary disease (COPD). We prospectively analysed CID in the FULFIL study. FULFIL (ClinicalTrials.gov NCT02345161; randomised, double-blind, double-dummy, multicentre study) compared 24 weeks of once daily, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 µg with twice daily budesonide/formoterol (BUD/FOR) 400/12 μg in patients aged ≥40 years with symptomatic advanced COPD (Global Initiative for Chronic Obstructive Lung Disease group D). A subset of patients received study treatment for up to 52 weeks. Time to first CID event was assessed over 24 and 52 weeks using two approaches for the health status component: St George's Respiratory Questionnaire and COPD assessment test. FF/UMEC/VI significantly reduced the risk of a first CID event by 47-52% versus BUD/FOR in the 24- and 52-week populations using both CID definitions (p<0.001). The median time to first CID event was ≥169 days and ≤31 days with FF/UMEC/VI and BUD/FOR, respectively. Only stable patients with no CID at 24 weeks demonstrated sustained clinically important improvements in lung function and health status at 52 weeks versus those who had experienced CID. Once daily, single-inhaler FF/UMEC/VI significantly reduced the risk of CID versus twice daily BUD/FOR with a five-fold longer period without deterioration.

Fluticasone propionate

10.1183/23120541.00047-2018

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Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Triple Therapy Compared with Other Therapies for the Treatment of COPD: A Network Meta-Analysis

Advances in Therapy (2022)

Afisi Ismaila Katrin Haeussler Alexandrosz Czira Ji-Hee Youn Mia Malmenäs

Randomized controlled trials (RCTs) comparing triple therapies (inhaled corticosteroid [ICS], long-acting β2-agonist [LABA], and long-acting muscarinic antagonist [LAMA]) for the treatment of chronic obstructive pulmonary disease (COPD) are limited. This network meta-analysis (NMA) investigated the comparative efficacy of single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus any triple (ICS/LABA/LAMA) combinations and dual therapies in patients with COPD. This NMA was conducted on the basis of a systematic literature review (SLR), which identified RCTs in adults aged at least 40 years with COPD. The RCTs compared different ICS/LABA/LAMA combinations or an ICS/LABA/LAMA combination with any dual therapy (ICS/LABA or LAMA/LABA). Outcomes of interest included forced expiratory volume in 1 s (FEV1), annualized rate of combined moderate and severe exacerbations, St George's Respiratory Questionnaire (SGRQ) total score and SGRQ responders, transition dyspnea index focal score, and rescue medication use (RMU). Analyses were conducted at 24 weeks (primary endpoint), and 12 and 52 weeks (if feasible). The NMA was informed by five trials reporting FEV1 at 24 weeks. FF/UMEC/VI was statistically significantly more effective at increasing trough FEV1 (based on change from baseline) than all triple comparators in the network apart from UMEC + FF/VI. The NMA was informed by 17 trials reporting moderate or severe exacerbation endpoints. FF/UMEC/VI demonstrated statistically significant improvements in annualized rate of combined moderate or severe exacerbations versus single-inhaler budesonide/glycopyrronium bromide/formoterol fumarate (BUD/GLY/FOR). At 24 weeks, the NMA was informed by five trials. FF/UMEC/VI showed statistically significant improvements in annualized rate of combined moderate or severe exacerbations versus UMEC + FF/VI and BUD/GLY/FOR. FF/UMEC/VI also demonstrated improvements in mean SGRQ score versus other triple therapy comparators at 24 weeks, and a significant reduction in RMU compared with BUD/GLY/FOR (160/18/9.6). The findings of this NMA suggest favorable efficacy with single-inhaler triple therapy comprising FF/UMEC/VI. Further analysis is required as additional evidence becomes available.

Fluticasone propionate

10.1007/s12325-022-02231-0

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Citations (22)

Association between Increased Risk of Pneumonia with ICS in COPD: A Continuous Variable Analysis of Patient Factors from the IMPACT Study

Pulmonary Therapy (2024)

Bhumika Aggarwal Paul Jones Alejandro Casas Mauro Gomes Siwasak Juthong

Despite the proven benefits of inhaled corticosteroid (ICS)-containing triple therapy for chronic obstructive pulmonary disease (COPD), clinicians limit patient exposure to ICS due to the risk of pneumonia. However, there are multiple factors associated with the risk of pneumonia in patients with COPD. This post hoc analysis of IMPACT trial data aims to set the risks associated with ICS into a context of specific patient-related factors that contribute to the risk of pneumonia. The 52-week, double-blind IMPACT trial randomized patients with symptomatic COPD and ≥1 exacerbation in the prior year 2:2:1 to once-daily fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI), FF/VI or UMEC/VI. Annual rate of on-treatment pneumonias in the intent-to-treat population associated with age, body mass index (BMI), percent predicted forced expiratory volume in 1 s (FEV1) and blood eosinophil count (BEC) was evaluated. This analysis revealed that the annual rate of pneumonia showed the lowest risk at the age of 50 years. The 95% confidence intervals (CI) between ICS-containing and non-ICS containing treatments diverged in ages > 63 years, suggesting a significantly increased ICS-related risk in older patients. In contrast, the annual rate of pneumonia rose in both groups below BMI of 22.5 kg/m2, but above that, there was no relationship to pneumonia rate and no differential effect between the two groups. The relationship between BEC and pneumonia was flat up to > 300/µL cells with ICS-containing treatment and then rose. In contrast, the rate of pneumonia with non-ICS containing treatment appeared to increase at a lower level of BEC (~ 200/µL). There was little evidence of a differential effect of older age, lower BMI, lower FEV1 and BEC on the pneumonia rate between ICS-containing and non-ICS containing treatments. This analysis points to the need for a balanced approach to risk versus benefit in the use of ICS-containing treatments in COPD. IMPACT ClinicalTrials.gov number, NCT02164513.

Fluticasone propionate

Rate ratio

10.1007/s41030-024-00255-1

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Citations (4)