Population Of Chronic Obstructive Pulmonary Disease Patients Research Articles

Eligibility of patients with chronic obstructive pulmonary disease for inclusion in randomised control trials investigating triple therapy: a study using routinely collected data

BackgroundRandomised control trials (RCTs) with strict eligibility criteria can lead to trial populations not commonly seen in clinical practice. We described the proportion of people with chronic obstructive pulmonary disease (COPD) in England eligible for RCTs investigating treatment with triple therapy.MethodsMEDLINE and Clinicaltrials.gov were searched for RCTs investigating triple therapy and eligibility criteria for each trial were extracted. Using routinely collected primary care data from Clinical Practice Research Datalink Aurum linked with Hospital Episode Statistics, we defined a population of COPD patients registered at a general practice in England, who were ≥ 40 years old, and had a history of smoking. Inclusion date was January 1, 2020. Patients who died earlier or left the general practice were excluded. Eligibility criteria for each RCT was applied to the population of COPD patients and the proportion of patients meeting each trial eligibility criteria were described.Results26 RCTs investigating triple therapy were identified from the literature. The most common eligibility criteria were post-bronchodilator FEV1% predicted 30–80%, ≥ 2 moderate/≥ 1 severe exacerbations 12-months prior, no moderate exacerbations one-month prior and no severe exacerbations three-months prior, and the use of maintenance therapy or ICS use prior to inclusion. After applying each RCT eligibility criteria to our population of 79,810 COPD patients, a median of 11.2% [interquartile range (IQR) 1.8–17.4] of patients met eligibility criteria. The most discriminatory criteria included the presence exacerbations of COPD and previous COPD related medication use with a median of 67.6% (IQR 8.5–73.4) and 63% (IQR 69.3–38.4) of COPD patients not meeting these criteria, respectively.ConclusionData from these RCTs may not be generalisable to the wider population of people with COPD seen in everyday clinical practice and real-world evidence studies are needed to supplement trials to understand effectiveness in all people with COPD.

Exploring the impact of varying definitions of exacerbations of chronic obstructive pulmonary disease in routinely collected electronic medical records.

Validity of exposure and outcome measures in electronic medical records is vital to ensure robust, comparable study findings however, despite validation studies, definitions of variables used often differ. Using exacerbations of chronic obstructive pulmonary disease (COPD) as an example, we investigated the impact of potential misclassification of different definitions commonly used in publications on study findings. A retrospective cohort study was performed. English primary care data from the Clinical Practice Research Datalink Aurum database with linked secondary care data were used to define a population of COPD patients ≥40 years old registered at a general practice. Index date was the date eligibility criteria were met and end of follow-up was 30/12/19, death or end of data collection. Exacerbations were defined using 6 algorithms based on definitions commonly used in the literature, including one validated definition. For each algorithm, the proportion of frequent exacerbators (≥2 exacerbations/year) and exacerbation rates were described. Cox proportional hazard regression was used to investigate each algorithm on the association between heart failure and risk of COPD exacerbation. A total of 315,184 patients were included. Baseline proportion of frequent exacerbators varied from 2.7% to 15.3% depending on the algorithm. Rates of exacerbations over follow-up varied from 19.3 to 66.6 events/100 person-years. The adjusted hazard ratio for the association between heart failure and exacerbation varied from 1.45, 95% confidence intervals 1.42-1.49, to 1.01, 0.98-1.04. The use of high validity definitions and standardisation of definitions in electronic medical records is crucial to generating high quality, robust evidence.

Value of Information Analysis of a Web-Based Self-Management Intervention for Chronic Obstructive Pulmonary Disease.

Objective: Technology-based programs can be cost-effective in the management of chronic obstructive pulmonary disease (COPD). However, cost-effectiveness estimates always contain some uncertainty, and decisions based upon them carry some risk. We conducted a value of information (VOI) analysis to estimate the value of additional research of a web-based self-management intervention for COPD to reduce the costs associated with uncertainty. Methods: We used a 10,000-iteration cost-effectiveness model from the health care payer perspective to calculate the expected value of perfect information (EVPI) at the patient- and population-level. An opportunity loss was incurred when the web-based intervention did not produce a greater net monetary benefit than usual care in an iteration. We calculated the probability of opportunity loss and magnitude of opportunity costs as a function of baseline health utility. We aggregated opportunity costs over the projected incident population of inpatient COPD patients over 10 years and estimated it as a function of the willingness-to-pay (WTP) threshold. Costs are in 2022 U.S. Dollars. Results: Opportunity losses were found in 22.7% of the iterations. The EVPIpatient was $78 per patient (95% confidence interval: $75-$82). The probability that the intervention was the optimal strategy varied across baseline health utilities. The EVPIpopulation was $506,666,882 over 10 years for a WTP of $50,000. Conclusions: Research estimated to cost up to $500 million would be warranted to reduce uncertainty. Future research could focus on identifying the impact of baseline health utilities to maximize the cost savings of the intervention. Other considerations for future research priorities include implementation efforts for technology-based interventions.

Stratification of COPD patients towards personalized medicine: reproduction and formation of clusters

The global initiative for chronic obstructive lung disease (GOLD) 2020 emphasizes that there is only a weak correlation between FEV1, symptoms and impairment of the health status of patients with chronic obstructive pulmonary disease (COPD). Various studies aimed to identify COPD phenotypes by cluster analyses, but behavioral aspects besides smoking were rarely included. The aims of the study were to investigate whether (i) clustering analyses are in line with the classification into GOLD ABCD groups; (ii) clustering according to Burgel et al. (Eur Respir J. 36(3):531-9, 2010) can be reproduced in a real-world COPD cohort; and (iii) addition of new behavioral variables alters the clustering outcome. Principal component and hierarchical cluster analyses were applied to real-world clinical data of COPD patients newly referred to secondary care (n = 155). We investigated if the obtained clusters paralleled GOLD ABCD subgroups and determined the impact of adding several variables, including quality of life (QOL), fatigue, satisfaction relationship, air trapping, steps per day and activities of daily living, on clustering. Using the appropriate corresponding variables, we identified clusters that largely reflected the GOLD ABCD groups, but we could not reproduce Burgel's clinical phenotypes. Adding six new variables resulted in the formation of four new clusters that mainly differed from each other in the following parameters: number of steps per day, activities of daily living and QOL. We could not reproduce previously identified clinical COPD phenotypes in an independent population of COPD patients. Our findings therefore indicate that COPD phenotypes based on cluster analysis may not be a suitable basis for treatment strategies for individual patients.

Patient and Clinical Demographics of New Users to Single-Inhaler Triple Therapy in Patients with Chronic Obstructive Pulmonary Disease.

IntroductionSingle-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy was approved by the United States Food and Drug Administration in 2017 as a maintenance therapy for chronic obstructive pulmonary disease (COPD). Patient characteristics and treatment patterns prior to initiating FF/UMEC/VI are currently unknown. This study assessed patient characteristics, exacerbation, and medication history in patients with COPD before the initiation of FF/UMEC/VI or multiple-inhaler triple therapy (MITT).MethodsThis was a retrospective study using the Optum Clinformatics® Data Mart. Patients who initiated FF/UMEC/VI triple therapy or MITT (consisting of a long-acting muscarinic antagonist [LAMA], long-acting β2-agonist [LABA], and inhaled corticosteroid [ICS]) between October 2017 and September 2018, were enrolled in commercial or Medicare Advantage Prescription Drug plans, were aged > 40 years, and had a COPD diagnosis were eligible. Patient characteristics, comorbidities, COPD medication use, exacerbations, and eosinophil counts were assessed in the 12-month baseline period prior to initiation of FF/UMEC/VI triple therapy or MITT.ResultsThe study population included 3933 FF/UMEC/VI users and 18,244 MITT users. Mean (standard deviation) patient age was 72.2 (8.6) years in FF/UMEC/VI users and 70.7 (9.7) years in MITT users. Prior to initiating triple therapy, the majority of FF/UMEC/VI (89.1%) and MITT (93.8%) users experienced a moderate or severe exacerbation or used a COPD maintenance therapy during the baseline period. In addition, 41.2% of FF/UMEC/VI users received overlapping ICS/LAMA/LABA, 20.3% received ICS/LABA, and 9.7% received LAMA/LABA.ConclusionIn this population of COPD patients, triple therapy was frequently initiated after previous maintenance medication use or an exacerbation, in line with treatment guideline recommendations.

Peak Inspiratory Flow Rate in COPD: An Analysis of Clinical Trial and Real-World Data.

BackgroundThe influence of peak inspiratory flow (PIF) on dose delivery from dry powder inhalers (DPIs) and association with treatment efficacy in patients with chronic obstructive pulmonary disease (COPD) has not been fully determined. In vitro studies have demonstrated adequate dose delivery through ELLIPTA DPI at PIF ≥30 L/min. This analysis of two clinical trials and a real-world population of COPD patients determined spirometric PIF distribution, and explored the relationship between PIF and outcomes in the trials.MethodsThe replicate Phase IV, 12-week, randomized, double-blind 207608/207609 (NCT03478683/NCT03478696) trials evaluated fluticasone furoate/umeclidinium/vilanterol via ELLIPTA DPI versus budesonide/formoterol+tiotropium in COPD patients. This post hoc analysis assessed spirometric PIF distribution at screening and relationship between PIF and lung function outcomes in the pooled 207608/207609 population. Spirometric PIF distributions in a real-world population of COPD patients were evaluated by retrospective analysis of the Kaiser Permanente Northwest (KPNW) database to assess similarities between clinical trial and real-world populations.ResultsA total of 1460 (207608/207609) and 3282 (KPNW) patients were included. There was considerable overlap between spirometric PIF distributions for both populations. Overall, 99.7% and 99.8% of the 207608/207609 and KPNW populations, respectively, reported spirometric PIF ≥50 L/min, estimated as equivalent to ELLIPTA PIFR ≥30 L/min. In the 207608/207609 combined analysis, there was no significant interaction between spirometric PIF and treatment for lung function endpoints, indicating treatment effect is independent of PIF.ConclusionNearly all COPD patients in the 207608/207609 and KPNW populations achieved spirometric PIF values estimated as equivalent to PIFR of ≥30 L/min through the ELLIPTA DPI. Lack of correlation between spirometric PIF at screening and treatment efficacy aligns with consistent dose performance from the ELLIPTA DPI across a wide range of PIFs, achieved by patients with COPD of all severities.

The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease (COPD) in an Italian Context of Real Life: The TRITRIAL Study Protocol.

BackgroundThe fixed triple combination Beclometasone dipropionate/Formoterol fumarate/Glycopyrronium (BDP/FF/G, Trimbow®), an extrafine formulation in a unique pressurized metered dose inhaler, is indicated for the maintenance treatment in adult patients with moderate to severe COPD, not adequately treated by ICS/LABA or LABA/LAMA. Besides the evidence from three randomized controlled trials, the impact of fixed triple therapy has not been extensively evaluated in a real-world population of COPD patients. TRITRIAL (TRIple Therapy in Real life: Impact on Adherence and HeaLth status) is a non-interventional study to assess the effect of BDP/FF/G in a real world setting in Italy.DesignTRITRIAL is a 12-month, multicenter, cohort, prospective, longitudinal observational study. Two follow-up visits will be performed at 6 and 12 months, respectively. The study includes the collection of anamnestic clinical and functional data before the start of BDP/FF/G. The study is built for digital conduction, from signature of the informed consent on a dedicated web platform, to the collection of questionnaires and clinical data on the eCRF.PopulationA total of 800 patients with COPD ranging from Global Initiative for Obstructive Lung Disease (GOLD) stages 2 to 4, receiving therapy with BDP/FF/G according to the Summary of Product Characteristics and local clinical practice, will be recruited. All concomitant therapies will be permitted for the duration of the study.EvaluationsThe primary endpoint is the change of CAT score at 12 months versus baseline. Secondary endpoints are adherence, health-related quality of life, sleep quality, disease-related outcomes (lung function and COPD exacerbations), device usability, economic resources consumption, and safety.ConclusionTRITRIAL study is expected to give relevant information about effectiveness of BDP/FF/G fixed triple therapy in a real-life setting of patients with COPD, where adherence, usability of inhalers and patient’s preference of the device are crucial factors for the success of the therapy.

Cost Effectiveness of Case Detection Strategies for the Early Detection of COPD.

The value of early detection and treatment of chronic obstructive pulmonary disease (COPD) is currently unknown. We assessed the cost effectiveness of primary care-based case detection strategies for COPD. A previously validated discrete event simulation model of the general population of COPD patients in Canada was used to assess the cost effectiveness of 16 case detection strategies. In these strategies, eligible patients (based on age, smoking history, or symptoms) received the COPD Diagnostic Questionnaire (CDQ) or screening spirometry, at 3- or 5-year intervals, during routine visits to a primary care physician. Newly diagnosed patients received treatment for smoking cessation and guideline-based inhaler pharmacotherapy. Analyses were conducted over a 20-year time horizon from the healthcare payer perspective. Costs are in 2019 Canadian dollars ($). Key treatment parameters were varied in one-way sensitivity analysis. Compared to no case detection, all 16 case detection scenarios had an incremental cost-effectiveness ratio (ICER) below $50,000/QALY gained. In the most efficient scenario, all patients aged ≥ 40years received the CDQ at 3-year intervals. This scenario was associated with an incremental cost of $287 and incremental effectiveness of 0.015 QALYs per eligible patient over the 20-year time horizon, resulting in an ICER of $19,632/QALY compared to no case detection. Results were most sensitive to the impact of treatment on the symptoms of newly diagnosed patients. Primary care-based case detection programs for COPD are likely to be cost effective if there is adherence to best-practice recommendations for treatment, which can alleviate symptoms in newly diagnosed patients.

EFFICACY AND SAFETY OF ACLIDINIUM BROMIDE IN PATIENTS WITH COPD, CARDIOVASCULAR RISK FACTORS, AND CHRONIC BRONCHITIS IN THE ASCENT STUDY

EFFICACY AND SAFETY OF ACLIDINIUM BROMIDE IN PATIENTS WITH COPD, CARDIOVASCULAR RISK FACTORS, AND CHRONIC BRONCHITIS IN THE ASCENT STUDY

Accelerated FEV1 decline and risk of cardiovascular disease and mortality in a primary care population of COPD patients.

Accelerated lung function decline has been associated with increased risk of cardiovascular disease (CVD) in a general population, but little is known about this association in chronic obstructive pulmonary disease (COPD). We investigated the association between accelerated lung function decline and CVD outcomes and mortality in a primary care COPD population.COPD patients without a history of CVD were identified in the Clinical Practice Research Datalink (CPRD)-GOLD primary care dataset (n=36 382). Accelerated decline in forced expiratory volume in 1 s (FEV1) was defined using the fastest quartile of the COPD population's decline. A Cox regression was used to assess the association between baseline accelerated FEV1 decline and a composite CVD outcome over follow-up (myocardial infarction, ischaemic stroke, heart failure, atrial fibrillation, coronary artery disease and CVD mortality). The model was adjusted for age, sex, smoking status, body mass index, history of asthma, hypertension, diabetes, statin use, Modified Medical Research Council (mMRC) dyspnoea score, exacerbation frequency and baseline FEV1 % predicted.6110 COPD patients (16.8%) had a CVD event during follow-up; median length of follow-up was 3.6 years (interquartile range (IQR) 1.7–6.1 years). Median rate of FEV1 decline was –19.4 mL·year−1 (IQR –40.5–1.9); 9095 patients (25%) had accelerated FEV1 decline (> –40.5 mL·year−1), 27 287 (75%) did not (≤ –40.5 mL·year−1). Risk of CVD and mortality was similar between patients with and without accelerated FEV1 decline (HRadj 0.98, 95% CI 0.90–1.06). Corresponding risk estimates were 0.99 (95% CI 0.83–1.20) for heart failure, 0.89 (95% CI 0.70–1.12) for myocardial infarction, 1.01 (95% CI 0.82–1.23) for stroke, 0.97 (95% CI 0.81–1.15) for atrial fibrillation, 1.02 (95% CI 0.87–1.19) for coronary artery disease and 0.94 (95% CI 0.71–1.25) for CVD mortality. Rather, risk of CVD was associated with a mMRC score ≤2 and two or more exacerbations in the year prior.CVD outcomes and mortality were associated with exacerbation frequency and severity and increased mMRC dyspnoea score but not with accelerated FEV1 decline.

PRS17 COST-EFFECTIVENESS OF CASE DETECTION STRATEGIES FOR THE EARLY DETECTION OF COPD

The value of early detection and treatment of chronic obstructive pulmonary disease (COPD) is currently unknown. We assessed the cost-effectiveness of various primary care-based case detection strategies for COPD. A previously validated discrete event simulation model of the general population of COPD patients in Canada was used to assess the cost-effectiveness of 16 case detection scenarios. In these scenarios, eligible patients (based on age, smoking history, or symptoms) received the COPD Diagnostic Questionnaire (CDQ) or screening spirometry, at 3- or 5-year intervals, during routine visits to a primary care physician. Newly diagnosed patients received treatment for smoking cessation and guideline-based inhaler pharmacotherapy. Analyses were conducted over a 20-year time horizon from the healthcare payer perspective. Costs are reported in 2015 Canadian dollars ($). Key treatment parameters were varied in one-way sensitivity analysis. Compared to no case detection, all 16 case detection scenarios had an incremental cost effectiveness ratio (ICER) below a $50,000/QALY willingness to pay threshold in the reference case analysis. In the most efficient scenario, all patients ≥40 years received the CDQ at 3-year intervals. This scenario was associated with an incremental cost of $180 per eligible patient, and an incremental effectiveness of 0.009 QALYs per eligible patient, resulting in an ICER of $21,108/QALY compared to the CDQ delivered to ever smokers at 5-year intervals, which was the next most highly-ranked scenario on the efficiency frontier. were most sensitive to the impact of treatment on the symptoms of newly diagnosed patients. When this was not associated with a utility benefit, case detection was no longer cost-effective. Primary care-based case detection programs for COPD are likely to be cost-effective if adherence to best-practice recommendations for treatment is high.

The cost-saving switch from inhaled corticosteroid-containing treatments to dual bronchodilation: a two-country projection of epidemiological and economic burden in chronic obstructive pulmonary disease.

Purpose:The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018 recommendations support maintenance treatment with long-acting bronchodilators in most symptomatic patients with chronic obstructive pulmonary disease (COPD). While restricting the overuse of inhaled corticosteroids (ICS) may influence healthcare utilization required to treat inadvertent respiratory (exacerbations and pneumonia) and diabetes-related events, it may also change the total medication cost. This analysis was performed to estimate the 5-year budget impact of switching from ICS-containing treatment combinations to dual bronchodilation, in line with the recommendations.Methods:The model quantified the budget impact of treatment and healthcare resource utilization when COPD patients were anticipated to switch from ICS-containing treatments to dual bronchodilation. Three switch scenarios were calculated with increasing proportions of patients on dual long-acting bronchodilators, to the detriment of ICS-containing double and triple combinations. Clinical and cost input data were based on results from clinical trials and Greek and Portuguese healthcare cost databases.Results:Healthcare resource use to manage exacerbations, pneumonia and diabetes-related events were projected to increase between 2019 and 2023 in parallel with the growing COPD patient population and associated costs were estimated at 52–57% of the total disease cost in the Greek and Portuguese base case scenarios. Total cost savings between 21 and 112 million EUR were projected when the proportion of patients on double and triple ICS-containing treatments was gradually reduced to 50% in scenario A, 20% in scenario B and 7% in scenario C. Sensitivity analyses showed that none of the model assumptions had a major impact on the projected savings.Conclusion:The alignment of COPD treatment with current recommendations may bring clinical benefits to patients, without substantial cost increases and even cost savings for payers. The reviews of this paper are available via the supplemental material section.

PHYSICAL ACTIVITY LEVEL IN STABLE COPD PATIENTS FROM CENTRAL EASTERN EUROPE: RESULTS FROM A LARGE OBSERVATIONAL STUDY

SESSION TITLE: Pulmonary Rehabilitation and Muscle Dysfunction SESSION TYPE: Original Investigations PRESENTED ON: 10/22/2019 10:45 AM - 11:45 AM PURPOSE: Physical activity (PA) is an important functional outcome in chronic obstructive pulmonary disease (COPD). Low levels of PA are associated with a higher risk of exacerbations, exacerbations-related hospitalizations and mortality in COPD patients. This study aimed to describe the PA level (PAL) in a large population of stable COPD patients in Europe. The results from 5 Central Eastern European (CEE) countries are presented. METHODS: This multinational, cross-sectional study (NCT03031769) was conducted in 11 countries. In total, 2162 COPD patients were enrolled; some 1422 patients were from CEE countries: Romania (RO) 406, Poland (PL) 356, Serbia (SB) 250, Bulgaria (BG) 210 and Slovakia (SK) 200. All patients had COPD with duration of ≥1 year and no exacerbation history or changes in maintenance treatment in the last 2 months before enrolment. At each study visit, dyspnea was assessed with modified Medical Research Council (mMRC) scale. PAL was assessed through patient self-reports during clinical interview and clinical judgment of physicians (no specific guidance provided). The EVS program (exercise vital sign) and Yale Physical Activity Survey (YAPS) were used for self-reports. Active/insufficiently active/inactive were defined as performing ≥150/149-1/0 minutes/week of moderate to vigorous exercise, respectively. RESULTS: The 5 cohorts of patients presented the following mean ages (years): BG 66.7, PL 67.0, RO 65.9, SK 66.6, SB 68.0. Most patients had moderate to severe airflow obstruction: BG 84.3%, PL 87.7%, RO 83.7%, SK 90.0%, SB 80.0%. In BG 72.8%, PL 64.0%, RO 72.4%, SK 67.5% and SB 51.6% patients had mMRC≥2. The percentages of self-reported vs. clinically judged active patients were: BG 33.8% vs 44.3%, PL 38.5% vs 32.9%, RO 23.9% vs 54.4%, SK 36.0% vs 59.0%, SB 31.2% vs 38.4%. The percentages of completely inactive patients as self-reported by subjects vs. clinically judged by physicians were: BG 27.1% vs 12.4%, PL 15.2% vs 13.2%, RO 37.2% vs 9.1%, SK 37.0% vs 7.0%, SB 30.8% vs 9.6%, respectively. By YPAS, the mean time spent in mostly light activities expressed in hours/day was BG 2.8, PL 2.4, RO 3.7, SK 2.9, SB 3.4. The summary index of YPAS indicated the following values in each country: BG 41.0, PL 37.8, RO 45.3, SK 45.0 and SB 43.9, where 51 is the cut-off score used to identify COPD patients at risk of sedentarism CONCLUSIONS: This study confirms low levels of physical activity among COPD patients in CEE countries. In the absence of standardized tools, physicians tend to overestimate the physical activity of their COPD patients. CLINICAL IMPLICATIONS: Physicians and patients have a different perception of physical activity. Generally, COPD patients are less active than their physicians perceive. Clinicians should be equipped with adequate tools to assess and promote physical activity in their respiratory patients. DISCLOSURES: Employee relationship with AstraZeneca Please note: $1001 - $5000 Added 03/10/2019 by Silviu Alecu, source=Web Response, value=Salary No relevant relationships by Adam Antczak, source=Web Response Employee relationship with AstraZeneca Please note: $1001 - $5000 Added 03/14/2019 by Yunqin Chen, source=Web Response, value=Salary No relevant relationships by Florin Mihaltan, source=Web Response No relevant relationships by Vesna Radulović, source=Web Response

PROFILE OF STABLE COPD PATIENTS IN COUNTRIES FROM CENTRAL EASTERN EUROPE: RESULTS FROM A LARGE OBSERVATIONAL STUDY

SESSION TITLE: Tuesday Abstract Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/22/2019 01:00 PM - 02:00 PM PURPOSE: The profile of patients with stable chronic obstructive pulmonary disease (COPD) in countries from Central Eastern Europe (CEE) is not clearly characterized. The population of stable COPD patients from 5 CEE countries participating in a large cross-sectional observational study is described here. METHODS: In a multinational study (NCT03031769), 2162 patients with stable COPD were enrolled from in 11 participating countries. In total, 1422 patients were enrolled from CEE: Romania (RO) n=406, Poland (PL) n=356, Serbia (SB) n=250, Bulgaria (BG) n=210 and Slovakia (SK) n=200. Eligible patients were aged ≥40 years with ≥1 year since COPD diagnosis. All patients were current or former smokers with a smoking history of ≥10 pack-years (PY). Stable disease was defined as no exacerbation history or changes in COPD maintenance treatment in last 2 months before enrolment. Exacerbation was defined as acute worsening of respiratory symptoms resulting in additional therapy. RESULTS: The mean age was 65.9 years in RO, 66.6 in SK, 66.7 in BG, 67.0 in PL and 68.0 in SB. More males were enrolled, from 61.0% in PL to 78.5% in SK and 83.5% in RO. Mean tobacco consumption (PY) for both smokers and non-smokers was 32.2 in BG, 32.5 in SK, 36.4 in PL, 38.1 in RO and 41.9 in SB. Mean post-bronchodilator FEV1 varied from 45.0% in BG and 47.8% in RO to 54.1% in PL, 54.5% in SK and 60.7% in SB. Most patients had moderate to severe airflow obstruction – percentages of patients ranged from 80.0% in SB, 83.7% in RO, 84.3% in BG, 87.7% in PL and 90.0% in SK. Mean number of exacerbations/patient in the last year (mild, moderate and severe) was 0.7 in SK, 1.9 in RO, 3.5 in BG, 4.8 in PL and 6.3 in SB. SB had the highest percentage of patients reporting severe exacerbations in last year (58.8%), while BG had highest percentage of patients with moderate exacerbations in last year (51.4%). Mean number of visits/year to chest specialist was 2.3 in BG, 3.4 in RO, 3.5 in SB, 3.7 in PL and 4.7 in SK. Mean score of COPD Assessment Test (CAT) ranged from 15 in SK and SB to almost 17 in PL, 19 in RO and 19.2 in BG. The distribution of low burden (A/C) vs. high burden (B/D) symptom categories by GOLD 2017 report differed at country level: 27.2% vs. 72.8% in BG, 35.9% vs. 64.1% in PL, 27.6% vs. 72.4% in RO, 32.5% vs. 67.5% in SK and 48.4% vs. 51.6% in SB. CONCLUSIONS: More discrepancies than similarities in characteristics of stable COPD patients were found across CEE countries participating in this study. The cultural, environmental and healthcare system differences may partly explain the results found. CLINICAL IMPLICATIONS: This large study allowed the homogeneous collection of data from 5 CEE countries. The variability of characteristics of stable COPD patients across countries may be explained by personal factors and local treatment and monitoring aspects that require further exploration. DISCLOSURES: Employee relationship with AstraZeneca Please note: $1001 - $5000 Added 03/10/2019 by Silviu Alecu, source=Web Response, value=Salary No relevant relationships by Adam Antczak, source=Web Response Employee relationship with AstraZeneca Please note: $1001 - $5000 Added 03/14/2019 by Yunqin Chen, source=Web Response, value=Salary No relevant relationships by Florin Mihaltan, source=Web Response No relevant relationships by Vesna Radulović, source=Web Response

Effect of bilateral lung transplantation on excessive dynamic airway collapse.

Excessive dynamic airway collapse (EDAC) is associated with significant respiratory morbidity. It has been hypothesized that EDAC may limit the benefits of lung transplantation in chronic obstructive pulmonary disease (COPD) patients. We aim to find the effect of bilateral lung transplantation on EDAC in COPD patients. Retrospective chart review was performed to identify patients with concomitant presence of COPD and EDAC before undergoing bilateral lung transplantation from December 2011 to December 2014. Pre- and post-transplant pulmonary function tests, flow-volume (FV) loops, computed tomography (CT) of the chest, and flexible bronchoscopies were studied. A total of 165 patients underwent bilateral lung transplantation during the study period. Eight patients had COPD and EDAC prior to the transplant. Post-transplantation, 7 out of 8 patients showed resolution of EDAC on expiratory CT chest and 1 patient did not have post-transplant CT chest. All eight showed no EDAC on post-transplant surveillance bronchoscopy. Post-transplant, mean predicted FEV1/FVC increased from 37% to 117% and mean predicted FEV1 increased from 20% to 61%. There is resolution of EDAC post-bilateral lung transplantation in this retrospective COPD patient population. EDAC should not be considered as a benefit-limiting factor to bilateral lung transplantation. However, prospective studies are required to explore potential indication.

Cross-sectional study of respiratory Aspergillus spp. colonization or infection in patients with various stages of chronic obstructive pulmonary disease (COPD) using culture vs non-culture based technique

Background COPD patients are now recognized to be at increased risk of colonization by Aspergillus spp. which may progress to invasive pulmonary aspergillosis (IA). Published data on the frequency of Aspergillus detection in COPD are limited. Methods A cross-sectional study was undertaken to determine Aspergillus colonization or infection in COPD patients undergoing bronchoscopy for any indication. Culture as well as galactomannan antigen (GM) and Aspergillus nucleic acid detection (PCR) were performed on bronchoalveolar lavage fluid (BAL). Results One hundred and fifty patients were included (44.7 % female, mean age 68.2 years). 21.3 % were inpatients, 74.7 % outpatients and 4 % were ICU patients. Investigation of lung masses was the most common indication (43.3 %) for bronchoscopy. Most patients (81.3 %) were either GOLD stage 1 or 2 COPD. Cancer was the most frequent co-morbidity (60.48 %). 12 % and 48.7 % were on systemic and inhaled steroids respectively. Lung mass was the most common (28.43 %) CT imaging finding. Seventeen patients (11.3 %) had a positive result for Aspergillus (Culture+Galactomannan+PCR). 76.4 % out of these seventeen were in the early stages (GOLD stage 1 or 2) of COPD. Conclusion Aspergillus sp. was detected in 3.3 % of patients by culture, which increased to 11.3 % if culture was combined with either a positive GM or PCR result. Overall the frequency of Aspergillus detection in this population of COPD patients was low which may reflect the predominance of Gold stages 1 and 2 among the study population.

Agreement between arterial and non-arterialised fingertip capillary blood gas and acid-base values

ABSTRACTBackground: Arterial puncture is considered the gold standard for obtaining blood gas and acid-base values and facilitates the assessment of acutely and critically ill patients, as well as control of patients in long-term oxygen therapy (LTOT). Substitutional capillary sampling has been proposed, as researchers cite lower complication rates, physician independence, lower degree of invasiveness and higher degree of patient comfort. An arterialised earlobe is considered the method of choice to obtain capillary blood sampling, but in an acute setting, the need for vasodilating pastes may be time-consuming and impractical.The aim of this study is to examine whether accurate blood gas and acid-base measurements can be obtained using non-arterialised fingertip blood.Materials and methods: Consecutive arterial punctures and non-arterialised capillary blood samples were drawn from 62 patients with stable-phase chronic obstructive pulmonary disease (COPD), and subsequently analysed. Agreement between arterial and capillary blood gas values was compared using the method recommended by Bland and Altman.Results: Results show that limits of agreement (LoA) regarding PO2 (LoA: −1.27–4.45 kPa); Base Excess (LoA: −1.35–0.55); lactate (LoA: −0.77–0.20 mmol/l) and SO2 (LoA: −0.02–0.06) are wider than what would be applicable for clinical use. However, clinically acceptable LoA were obtained regarding PCO2 (LoA: −0.64–0.38 kPa); pH (LoA: −0.02–0.03), and HCO3− (LoA: −1.06–0.55 mmol/l).Conclusion: LoA for PCO2, pH and HCO3− indicate that measurement of these parameters in non-arterialised capillary blood may be useful in clinical practice/an acute setting.What this paper adds:Capillary blood sampling provides a fast, non-invasive means of obtaining blood gas-values;Traditionally, capillary blood sampling for blood gas analysis is obtained from the earlobe using arterialisation;The present study presents accurate measurements of PCO2, HCO3− and pH using non-arterialised fingertip capillary blood;The present study is the first to show this in a population of stable-phase COPD patients.

Lung transplantation for chronic obstructive pulmonary disease: past, present, and future directions.

Lung transplantation offers an effective treatment modality for patients with end-stage chronic obstructive pulmonary disease (COPD). The exact determination of when to refer, list, and offer transplant as well as the preferred transplant procedure type remains unclear. Additionally, there are special considerations specific to patients with COPD being considered for lung transplantation, including the implications of single lung transplantation on lung cancer risk, native lung hyperinflation, and overall survival. The International Society for Heart and Lung Transplantation's most recent recommendations rely on an assessment of COPD severity based on BODE index. Despite the lack of evidence supporting a mortality benefit of bilateral over single lung transplantation for COPD patients, the majority of transplants performed in this population remain bilateral. Some of the concerns specific to single lung transplantation remain the possibility of de novo native lung cancer and the hemodynamic and physiologic implications of acute native lung hyperinflation. COPD remains the most common worldwide indication for lung transplantation. Ongoing study is still required to assess the overall survival benefit of lung transplantation and assess the overall quality of life impact on the COPD patient population.

Impact of the IMPACT Trial.

The latest iteration of the Global initiative for chronic Obstructive Lung Disease (GOLD)1 guidelines emphasizes the use of long-acting muscarinic antagonist /long-acting beta2-agonist (LAMA/LABA) combination therapy as maintenance therapy before triple therapy (inhaled corticosteroid [ICS]/LABA/LAMA) for chronic obstructive pulmonary disease (COPD) patients in the GOLD Group D and before an ICS/LABA combination in Group C. The exception for this is perhaps for those patients who have known, pre-existing asthma or are considered to have an asthma/COPD overlap. This recommendation is predicated on evidence that LABA/LAMA combinations have been shown to improve lung function and reduce symptoms as well as reduce exacerbations for patients who have had 1 or more exacerbation per year2,3 in combination with the evidence that inhaled corticosteroids increase the risk of pneumonia in at least a subset of individuals with COPD.4,5 Indeed, there has been a renewed debate regarding the exact role for inhaled corticosteroids in COPD overall. In this issue of the Journal Club we review the pivotal study , “InforMing the Pathway of COPD Treatment (IMPACT), that compares single inhaler triple therapy (LABA/LAMA/ICS) versus the same ICS/LABA in combination versus with the same LABA/LAMA in combination. The major focus of this Journal Club is the IMPACT study and how it helps to inform us regarding the COPD patient population that may be best suited for use of inhaled steroids. I provide the abstracts from additional recent studies that provide additional food for thought on how we might further refine the role for inhaled corticosteroids in COPD patients. Note: Abstracts are presented in their original, published format and have not been edited to match JCOPDF style.

Case-finding for alpha1-antitrypsin deficiency in Kazakh patients with COPD

Background Alpha-1-antitrypsin deficiency (AATD) is an under-diagnosed condition in patients with chronic obstructive pulmonary disease (COPD). The aim of this study was to screen for AATD in Kazakh patients with COPD using dried blood spot specimens.MethodsThe alpha1-antitrypsin (AAT) concentration was determined by nephelometry, PCR was used to detect PiS and PiZ alleles; and isoelectric focusing was used to confirm questionable genotype results and detect rare AAT variants.ResultsTo this aim, 187 Kazakh subjects with COPD were recruited. Blood samples were collected as dried blood spot. Genotyping of 187 samples revealed 3 (1.6%) PI*MZ and 1 (0.53%) PI*MS, Phenotyping identified also two sample (1.1%) with phenotype PiMI. Allelic frequencies of pathological mutations Z, S and I resulted 0.8%, 0.3%, 0.5%, respectively, in COPD Kazakh population.ConclusionThis study proved that AATD is present in the Kazakh population. These results support the general concept of targeted screening for AAT deficiency in countries like Kazakhstan, with a large population of COPD patients and low awareness among care-givers about this genetic condition.