Biomarkers of collagen turnover are related to annual change in FEV in patients with chronic obstructive pulmonary disease within the ECLIPSE study.

Background: Change in forced expiratory volume in one second (FEV) is important for defining severity of chronic obstructive pulmonary disease (COPD). Serological neoepitope markers of collagen turnover may predict rate of change in FEV.

Methods: One thousand COPD subjects from the observational, multicentre, three-year ECLIPSE (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints) study (NCT00292552, trial registration in February 2006) were included.

Pneumonia risk with inhaled fluticasone furoate and vilanterol in COPD patients with moderate airflow limitation: The SUMMIT trial.

Rationale: Pneumonia risk with inhaled corticosteroid use in chronic obstructive pulmonary disease (COPD) has not been thoroughly assessed in patients with moderate airflow limitation.

Objectives: To determine the incidence of pneumonia and risk factors in COPD patients with moderate airflow limitation who had, or were at high risk for cardiovascular disease.

Methods: In the Study to Understand Mortality and MorbidITy in COPD (SUMMIT), 16,590 subjects with moderate airflow limitation (50% ≤ FEV ≤ 70% predicted) and heightened cardiovascular risk were randomized double-blind 1:1:1:1 to inhaled once-daily vilanterol 25 μg (VI), fluticasone furoate 100 μg (FF), vilanterol 25 μg combined with 100 μg fluticasone furoate (FF/VI), or matched placebo.

Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice: an open-label, parallel group, randomised controlled trial.

Background: Evidence for management of asthma comes from closely monitored efficacy trials done in highly selected patient groups. There is a need for randomised trials that are closer to usual clinical practice.

Methods: We did an open-label, randomised, controlled, two-arm effectiveness trial at 74 general practice clinics in Salford and South Manchester, UK.

Fluticasone Furoate, Vilanterol, and Lung Function Decline in Patients with Moderate Chronic Obstructive Pulmonary Disease and Heightened Cardiovascular Risk.

Rationale: Many patients with chronic obstructive pulmonary disease (COPD) have an accelerated loss of lung function. It is unclear whether drug treatment can modify this in patients with moderately severe disease.

Objectives: In a prespecified analysis of the key secondary outcome in SUMMIT (Study to Understand Mortality and Morbidity), we investigated whether the inhaled corticosteroid fluticasone furoate (FF; 100 μg), the long-acting β-agonist vilanterol (VI; 25 μg), or their combination (FF/VI) modified the rate of decline in FEV compared with placebo.

The Association of Depressive Symptoms With Rates of Acute Exacerbations in Patients With COPD: Results From a 3-year Longitudinal Follow-up of the ECLIPSE Cohort.

Background: Depression increases disability and health care utilization in older patients with chronic obstructive pulmonary disease (COPD).

Objectives: To determine contribution of depressive symptoms to the incidence of moderate-severe and severe acute exacerbations of COPD (AECOPD) over 3 years.

Design: We analyzed data collected from a prospective cohort of patients with COPD (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints; ECLIPSE).

Stability of the frequent COPD exacerbator in the general population: A Danish nationwide register-based study.

Unlabelled: Exacerbation frequency is central in treatment strategies for chronic obstructive pulmonary disease. However, whether chronic obstructive pulmonary disease patients from the general population with frequent exacerbations continue to have frequent exacerbations over an extended period of time is currently unknown. In this study, we aimed to investigate the stability of the frequent exacerbator in a population-based setting.

Association of Blood Eosinophil and Blood Neutrophil Counts with Asthma Exacerbations in the Copenhagen General Population Study.

Background: Blood eosinophil count is a marker of eosinophilic airway inflammation and disease severity in asthma. However, blood neutrophil count might also be associated with disease severity. We tested the hypothesis that high blood eosinophil and neutrophil counts are both associated with the risk of asthma exacerbations among individuals with asthma from the general population.

High levels of biomarkers of collagen remodeling are associated with increased mortality in COPD - results from the ECLIPSE study.

Background: There is a need to identify individuals with COPD at risk for disease progression and mortality. Lung tissue remodeling is associated with the release of extracellular matrix (ECM) fragments into the peripheral circulation. We hypothesized that ECM remodeling was associated with mortality in COPD and measured neo-epitopes originating from ECM proteins associated with lung tissue remodeling.

Natural experiments and large databases in respiratory and cardiovascular disease.

A number of scientific questions cannot be tested in a laboratory, clinic or clinical trial setting. In many cases, observational data can be used to test such hypotheses.This article illustrates how epidemiology can contribute and shows the different ways of using observational data through three approaches: 1) prospective cohort study design; 2) time series analysis; and 3) a nested case-control design in pharmacoepidemiology.

Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD.

Background: Most guidelines recommend either a long-acting beta-agonist (LABA) plus an inhaled glucocorticoid or a long-acting muscarinic antagonist (LAMA) as the first-choice treatment for patients with chronic obstructive pulmonary disease (COPD) who have a high risk of exacerbations. The role of treatment with a LABA-LAMA regimen in these patients is unclear.

Methods: We conducted a 52-week, randomized, double-blind, double-dummy, noninferiority trial.

Blood Eosinophils and Exacerbations in Chronic Obstructive Pulmonary Disease. The Copenhagen General Population Study.

Rationale: Whether high blood eosinophils are associated with chronic obstructive pulmonary disease (COPD) exacerbations among individuals with COPD in the general population is largely unknown.

Objectives: To test the hypothesis that high blood eosinophils predict COPD exacerbations.

Methods: Among 81,668 individuals in the Copenhagen General Population Study, we examined 7,225 with COPD based on spirometry.

Associations between gastro-oesophageal reflux, its management and exacerbations of chronic obstructive pulmonary disease.

Aim: To determine factors, overall and by sex, associated with self-reported gastro-oesophageal reflux disease (GORD) in chronic obstructive pulmonary disease (COPD) patients, and to evaluate relationships between GORD, its modification by acid suppression medications (Proton Pump Inhibitors [PPI]/histamine-2 receptor antagonists [H2RA]) and exacerbations of COPD and mortality.

Methods: Logistic regression was used to determine factors associated with GORD; Cox proportional hazards models were used to calculate adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for GORD and risk of exacerbation and death.

Results: Among 2135 COPD patients from the ECLIPSE cohort, 547 patients self-reported GORD, with female preponderance; 237 were taking PPI/H2RA.