Influence of Reliance on Historical Blood Eosinophil Counts on ICS Prescribing by GOLD 2019 Thresholds...
Chronic Obstructive Pulmonary DiseaseBlood eosinophils are a type of white blood cell that helps fight infection. They have a number of different functions but are primarily involved in numerous inflammatory processes. They are recruited from the blood into sites of inflammation. In patients with COPD, higher blood eosinophil count (BEC) predicts a greater reduction in moderate and severe exacerbations in response to inhaled corticosteroid (ICS) therapy. The Global Initiative for Chronic Obstructive Lung Disease strategy (GOLD 2019) recommends the use of BEC to guide ICS therapy and states that eosinophil levels above 300 cells/μL can help identify responders, guiding initial dual therapy, with "little or no effect at a BEC < 100 cells/μL". The National Institute for Health and Care Excellence (NICE) COPD 2018 guideline states that a higher BEC is associated with ICS response, but does not specify a threshold. Earlier research studies have suggested that at lower levels of BEC the harm of ICS due to pneumonia is greater than the benefit of severe exacerbation reduction. Patients with COPD can have "flare ups" of their disease known as exacerbations. Blood eosinophils play a critical role in assessing severity of these exacerbations and guiding management. The association between BEC and reduction in exacerbation frequency is based on BEC measured when the patient is clinically stable. Transient low eosinophil count (eosinopenia with BEC < 50 cells/μL) during severe exacerbation is extremely common. In the Dyspnoea, Eosinopenia, Consolidation, Acidaemia and atrial Fibrillation (DECAF) score derivation and validation studies combined, eosinopenia was present on admission in 1,340 of 2,645 severe exacerbations of COPD (ECOPD) and is associated with longer length of stay, higher in-hospital and one year mortality. Although eosinophilic COPD exacerbations occur, overall BEC during moderate or severe exacerbation is lower than stable state. In ECOPD managed in critical care low BEC is associated with higher rate of septic shock and mortality. BEC are also suppressed during other acute illnesses, notably sepsis. Failure to recognise that BEC are often suppressed during acute illness compared to stable state may lead to ICS therapy being inappropriately withheld. The effect of exacerbation and other acute illnesses on eosinophils is under-appreciated. Both NICE and GOLD guidelines fail to mention whether BEC should be prospectively measured when patients are stable (reflecting RCT evidence), or if reliance on historical values is acceptable. In routine practice some clinicians rely on previous BECs to avoid a delay in treatment decisions. A number of these historical counts will have been taken during illness, underestimating the patients' stable-state BEC. Conversely, COPD is associated with other medical conditions, and BEC may be requested for reasons other than acute illness. Using the highest BEC from multiple measures in the previous 24 months may therefore better agree with stable state counts. The primary aim of this trial is to assess the reliability of using BEC over the preceding 24 months to assess COPD eosinophil phenotype at both GOLD thresholds. The primary outcome will be based on using the highest of at least three BEC. Secondary outcomes include a) the level of agreement between baseline stable state BEC and both mean and the highest BEC over the preceding 24 months, b) the influence of the number of BEC measures available and c) the effect of limiting the time frame from 24 months to the previous 12 months. BEC is associated with disease severity, providing further evidence that COPD eosinophil phenotype may change over time. As an exploratory analysis, periods of sustained change in eosinophil phenotype will be sought, and the relationship between eosinophil phenotype and patient characteristics and certain medication will be assessed. The investigators will also assess the relations between the dependent variables stable state absolute eosinophil and basophil counts and both eosinophil to basophil and neutrophil to lymphocyte ratios and the following clinical outcomes: a) moderate and severe exacerbations and b) mortality. Some of these variables have previously been shown to be related to disease severity and mortality.
Comparison of Respiratory Muscle Activations During Dyspnea Reduction Positions in Individuals
Chronic Obstructive Pulmonary DiseaseChronic and progressive dyspnea is the most characteristic symptom of chronic obstructive pulmonary disease. There are studies in the literature showing that electromyography activations of respiratory muscles increase in individuals with chronic obstructive pulmonary disease and that the severity of the perceived shortness of breath is associated with muscle activation. However, no study has been found comparing respiratory muscle activations during pursed lip breathing and normal breathing in the dyspnea reduction positions and supine position used in the treatment and management of chronic obstructive pulmonary disease. The aim of this study is to evaluate the effects of different dyspnea reduction positions on respiratory muscle activations separately, to compare respiratory muscle activation during normal breathing, respiratory control and pursed lip breathing during these different positions, and to classify muscle activations according to the severity of chronic obstructive pulmonary disease.
Functional and Structural Lung Imaging in Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary DiseaseAlpha 1-Antitrypsin DeficiencyThis study aims to use novel proton-based MRI techniques to assess lung function and structure in healthy volunteers and patients with chronic obstructive pulmonary disease (COPD) and alpha-1-anti-trypsin deficiency (A1ATD). These novel MRI measures will be compared to matched contemporary clinical diagnostic tools, namely pulmonary function tests (PFTs) and computed tomography (CT) scans. MRI has the advantages of avoiding ionising radiation exposure (unlike CT scans) and can also provide regional measures of lung function (unlike PFTs which provide global measures of function). In addition, these MRI techniques do not require the use of any inhaled or injected contrast agents. Some patients enrolled in this study will be undergoing a lung volume reduction (LVR) procedure as part of their normal clinical care. LVR is an intervention for patients with severe lung disease and hyperinflation. It is a palliative therapy that helps to reduce lung hyperinflation through insertion of small valves in the airway or surgical removal of parts of the lung. This can lead to improvements in symptoms such as breathlessness and improve exercise tolerance due to better functioning of the lung. In this study, we will explore how lung MRI measures can be used to assess patients before and after an LVR intervention. This study will take place at the University of Nottingham in collaboration with Nottingham University Hospitals NHS Trust. The study will last for 3 years and participants will be asked to attend a screening visit (lasting up to 1 hour) and either one or two study visits (each lasting up to 3 hours).
The 7-Visit Transition of Care Hospital to Home Intervention: A Pilot Study
Chronic Obstructive Pulmonary DiseaseChronic Heart FailureNew approaches to care transitions must deploy a longer-term and more intensive program that provide an array of services that address underlying social determinants of health (e.g. lack of adequate social support, lack of self-efficacy in managing symptoms and medications, impoverished living conditions, inability to connect with primary care and access. In addition, programs must be adaptable to meet the specific needs of individual patients. Our collaboration of health services researchers, quantitative scientists, and physicians propose to develop and implement a 90-day intensive and comprehensive intervention to support newly discharged patients with COPD and/or CHF. The proposed intervention will utilize a three-person team (registered nurse, clinical social worker, and a pharmacist) to provide an array of medical and social services specifically targeted to meet the needs of individual patients and their families. Aim: To determine using a randomized control trial, whether participation in an intensive series of 7 home-visits that provide tailored medical and social services among newly discharged low-income Medicare patients with COPD and/or CHF results in a) better patient-reported outcomes and b) a reduced likelihood of repeat hospital care (ED use or hospitalization) relative to a group of patients who receive usual discharge instructions.
Respiratory Registry for Lung Health: a Prospective, Observational Study on Adult Patients With...
Chronic Obstructive Pulmonary DiseaseAsthmaThe database will contain a wide range of demographic, clinical, radiological, laboratory, functional, microbiological, treatment, and clinical outcomes data on adults with chronic obstructive pulmonary disease (COPD) and asthma enrolled during stable state with annual follow-up (either one or two-year follow up). Primary Objective: To collect clinical (including quality of life measurements), laboratory (including non-invasive measurement of biomarkers), microbiological, radiological, functional, treatment variables and clinical outcomes, in adult patients with either asthma or COPD during stable state. Secondary Objectives: To identify genetic and other omics patterns to develop phenotype handprints for adults with either asthma or COPD. To characterize the airways microbiome in stable patients with either asthma or COPD and identify correlation with clinical phenotypes and/or endotypes.
Selective Manual Therapy Techniques in Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary DiseaseOur study aiming for determining the combined effect of selective manual therapy techniques in chronic obstructive pulmonary disease patients
Health Outcomes With CPAP or NIV in Patients With COPD and a Sleep Related Breathing Disorder
Chronic Obstructive Pulmonary DiseaseSleep Related Hypoventilation2 moreChronic obstructive pulmonary disease (COPD) is a chronic lung disease affecting an estimated 1 in 10 Canadians. Symptoms include persistent shortness of breath, cough and sputum production. The symptoms can be serious when people with COPD experience a flare of their disease and may lead to hospitalization or death. Improving other conditions that affect COPD control is one way to improve the health of people with COPD. Obstructive sleep apnea (OSA) is the most common breathing problem during sleep, and commonly co-exists with COPD. Although diagnosing and treating OSA is encouraged, it has not been highlighted in guidelines that recommend ideal COPD care. People with COPD and OSA have lower sleep quality and lower oxygen levels during sleep compared to people with OSA. Despite these differences, treatment of OSA in people with COPD is modeled after treatment of OSA in the general population, generally using treatment with continuous positive airway pressure (CPAP) with the possible addition of oxygen through the CPAP machine. There are few studies looking at other types of treatment including noninvasive ventilation (NIV) in people with COPD and OSA. The majority of studies of NIV in COPD has been for people with other reasons to use NIV including acute respiratory failure or chronic hypercarbic respiratory failure and did not include people with risk factors for OSA or who had undergone overnight sleep studies. In Alberta, NIV is provided province wide for people who have both OSA who do not meet certain physiologic targets in their oxygen levels or breathing patterns after CPAP is applied on an overnight sleep study. NIV is provided preferentially to CPAP and oxygen, providing an opportunity to look at health outcomes when NIV is used instead of CPAP for the treatment of patients with COPD. Through this study, we will measure whether people with COPD and a sleep related breathing disorder such as OSA have fewer severe flares of COPD after starting CPAP or NIV. We will evaluate whether the number of Emergency Department visits, hospitalizations or deaths lowers after starting CPAP or NIV.
Multidimensional Individualized Nutritional Therapy for Individuals With Severe COPD
Chronic Obstructive Pulmonary DiseaseIndividuals with severe chronic pulmonary disease often life isolated with a high burden of symptoms. Nutritional risk and low quality of life are common, and both associated with increased societal cost and poor prognosis. COPD is a complex and progressive disease with changing clinical states that influences nutritional status and quality of life in different ways. The primary aim is to improve quality of life for individuals with severe COPD. 120 individuals are recruited from the outpatient clinic at Nordsjællands Hospital in Denmark to a randomized controlled trial with two parallel groups (intervention and control). The intervention will last for 3 months comprising four elements including nutritional plan, regular contact, informal caregiver/friendly reminder and a weight dairy. We expect that the intervention will improve quality of life, nutritional status and prognosis.
COVID-19, Patients' Evolution and the Influence of the Pandemic on Health Care and Outcomes in Chronic...
COVID-19 PandemicPulmonary Disease4 moreObjectives: 1.- To evaluate the changes in health care and use of services in patients with chronic diseases such as chronic obstructive pulmonary disease (COPD), heart failure and major depression between 2017-2019 and the years 2020-2022, COVID pandemic period, and to see their relationship with clinical outcomes (in terms of mortality, admissions, death, current situation of his disease) and changes in health-related quality of life. 2- To evaluate the health care provided to a cohort of patients diagnosed with SARSCOV-2 (COVID-19 positive) during 2020 based on accessibility, equity and outcomes obtained. 3-To evaluate the evolution of the cohort of patients diagnosed with SARSCOV-2 after two years of follow-up since their diagnosis and create clinical prediction rules for the persistence of symptoms. Methodology. Four cohorts already created in previous projects are included: three of chronic patients, COPD, heart failure, major depression, all of 2017, and for which baseline information is available for follow-up of the health care they received in the 2017-19 period compared to that received during the 2020-22 period and to see the changes in their health-related quality of life from baseline based on generic and specific questionnaires for each of the pathologies included. Another cohort of positive and admitted patients for COVID-19 in 2020 is included, in whom the services received will be evaluated and recorded symptoms persistency that may have had up to two years after their index admission to develop tools for predicting the persistence of symptoms in the medium-long term.
Smartphone-based Self-management in COPD Patients: A Needs Assessment Survey
Chronic Obstructive Pulmonary DiseaseCOPD patients often experience multiple symptoms (e.g. dyspnea, cough, and deteriorating quality of life) and have imposed a substantial economic and social burden on health care. The current proposal is to explore the information needs of COPD patients and to evaluate the feasibility and acceptability of a smartphone-based instant messaging self-management support program to improve the quality of life in patients with COPD.