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231 active trials for Chronic Obstructive Pulmonary Disease

Long-term Effect of an Health Education Program on Daily Physical Activity in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Main objective: To compare the level of physical activity (PAL) at 12 months in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) between those who completed a health education program and those who did not. Study patients. Subjects older than 35 years; diagnosis of moderate to very severe COPD (FEV1 <80% predicted), established at least 3 months; current or former smoker with an accumulated consumption >10 packs x year; and hospital admission for COPD exacerbation. Design. Randomized, parallel and open-label clinical trial, controlled with conventional treatment. Intervention: During hospitalization, selected patients will receive conventional treatment. At discharge, they will be randomized (1:1) to control group [treatment and follow-up according to conventional clinical practice] or intervention group [in addition to conventional treatment and follow-up, the patients will be referred to a nursing consultation for perform two health education sessions, at 15 and 30 days after hospital discharge]. Measurements. At 15 days and 12 months after discharge, the following determinations will be made: anthropometric characteristics; clinical evaluation (smoking history, date of COPD diagnosis, comorbidities, current medication; health care utilization; moderate or severe COPD exacerbations); questionnaires (mMRC, Charlson, COPD-specific co-morbidity test (COTE), COPD Assessment Test (CAT) and LCADL), spirometry and six-minutes walking test; and evaluation of daily physical activity using an accelerometer.

Start: October 2016

Investigating Health Related Quality of Life in Patients With Chronic Respiratory Failure

To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it.

Start: December 2019

A Study of Patients With Chronic Disease

TARGET-RWE is a 10-year, international, longitudinal, observational study of patients with chronic disease designed to specifically address important clinical questions that remain incompletely answered from registration trials. The protocol will follow a master protocol design in which a shared study infrastructure supports progressive development of the registry across the spectrum of chronic diseases.

Start: February 2020

Cardiovascular Risk and Chronic Obstructive Pulmonary Disease

The principal objective of the study is to measure parameters of inflammation, oxidative stress, and vascular, respiratory, and peripheral muscle function parameters, and identify parameters indicative of evolving cardiovascular risk (CVR) in COPD patients, using multivariate analysis.

Start: January 2017

RECEIVER: Digital Service Model for Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease (COPD) is a serious but treatable chronic health condition. Optimised management improves symptoms, complications, quality of life and survival. Disease exacerbations, which have adverse outcomes and often trigger hospital admissions, underpin the rising costs of managing COPD (projected increase in the United Kingdom (UK) to £2.3bn by 2030). The costs and care-quality gap of COPD exacerbations, coupled with the global rising prevalence present a major healthcare challenge. This study proposal, which has been developed in partnership with patients, clinicians, enterprise and government representation is to conduct an implementation and effectiveness observational cohort study to establish a continuous and preventative digital health service model for COPD. The implementation proposals comprise: - Establishing a digital resource for high-risk COPD patients which contains symptom diaries (structured patient reported outcome questionnaires), integrates physiology monitoring (FitBit and home NIV therapy data), enables asynchronous communication with clinical team, supports COPD self-management and tracks interaction with the service (for endpoint analyses). Establishing a cloud-based clinical COPD dashboard which will integrate background electronic health record data, core COPD clinical dataset, patient-reported outcomes, physiology and therapy data and patient messaging to provide clinical decision support and practice-efficiencies, enhancing delivery of guideline-based COPD care. Use the acquired dataset to explore feasibility and accuracy of machine-learned predictive modelling risk scores, via cloud-based infrastructure, which will be for future prospective clinical trial. Our primary endpoint for the effectiveness evaluation is number of patients screened and recruited who successfully utilise and engage with this RECEIVER clinical service. The implementation components of the project will be iterated during the study, based on patient and clinical user experience and engagement. Secondary endpoints include a number of specified clinical outcomes, clinical service outcomes, machine-learning supported exploratory analyses, patient-centred outcomes and healthcare cost analyses.

Start: August 2018

Study of COPD Subgroups and Biomarkers

SPIROMICS I and SPIROMICS II are observational studies of Chronic Obstructive Pulmonary Disease (COPD). SPIROMICS I had two main aims: (1) To find groups of patients with COPD who share certain characteristics; (2) To find new ways of measuring whether or not COPD is getting worse and so provide new ways of testing whether a new treatment is working. SPIROMICS II has three primary aims. Aim 1 is to define the natural history of "Smokers with symptoms despite preserved spirometry" and characterize the airway mucus abnormalities underlying this condition. Aim 2 is to determine the radiographic precursor lesion(s) for emphysema, and identify the molecular phenotypes underlying airway disease and emphysema. Aim 3 is to advance understanding of the biology of COPD exacerbations through analysis of predisposing baseline phenotypes, exacerbation triggers and host inflammatory response.

Start: November 2010

Exploring Respiratory Health Outcomes From Sustained Use of Efficient Cookstoves

Household air pollution (HAP) is a leading risk factor for global burden of disease. Resource-constrained communities of the world especially women and children are significantly impacted by this challenge. To address household air pollution, cleaner and more efficient improved cookstoves (ICS) have been disseminated to low resource communities. Although there has been initial uptake of these stoves, sustained use has been inconsistent adding to the challenge of household air pollution. There is limited understanding at the intersections of social, ecological, and technical determinants of sustained use of ICS, and how is sustained use of ICS associated with exposure and health outcomes in poor communities. The overarching goal of this exploratory study is to initiate a comprehensive research program that will facilitate the use of ICS and investigate whether they render significant health benefits among rural Indian households. The investigators installed ICS (model: Eco-Chulla XXL) in select households that primarily use biomass for cooking, and evaluate the intervention based on three specific aims: To generate preliminary emissions data [particulate matter - mass and surface area based, carbon monoxide (CO)] from ICS and its effect on respiratory health outcomes that will facilitate the development of a pivotal clean cookstove intervention To generate effect size data that establish the feasibility and inform the sample size of a pivotal trial whose primary objective will be sustained improvements in the respiratory health of women and children in rural India To evaluate factors which enable and hinder the sustained use of clean cookstove technologies by the rural poor in India so that the investigators can develop a more refined pivotal intervention focused on improving respiratory health

Start: November 2014

Clinical Impact of Pharmaceutical Consultations in Patients Treated for Chronic Obstructive Pulmonary Disease at Home

The implementation of pharmaceutical consultations in the city or at the hospital could modify the occurrence of exacerbations related to chronic obstructive pulmonary disease after return of the patient to his home.

Start: January 2019

Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal

Chronic Obstructive Pulmonary Disease (COPD) is the fourth most important cause of death worldwide and is one of the commonest non-communicable diseases (NCDs) in Nepal. The presence of risk factors like indoor and outdoor air pollution, the high prevalence of smoking and lack of general awareness of COPD makes it a serious public health concern. However, no attempt has been made in Nepal to estimate its burden and address the disease at the community level. This community-based cluster randomized controlled study aims to fulfil that gap through mobilization of Female Community Health Workers (FCHVs) who will be trained to perform a certain set of health promotion activities aimed at prevention of the disease and its progression. Baseline and follow-up surveys will be conducted to compare the intervention and control groups. This study has the potential to generate evidence in helping address NCDs in Nepal and also other similar resource-limited countries.

Start: December 2019

Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort

Background Chronic Obstructive Pulmonary Disease (COPD) is an inflammatory disease of the lungs, which is most commonly caused by smoking. It is characterized as not fully reversible airflow limitation, chronic cough and dyspnoea. Being the fourth leading cause of death worldwide, COPD is an important public health challenge and can be prevented and treated. It is estimated that at least 400,000 individuals in Switzerland are affected by COPD. This number may increase in the coming years due to increasing nicotine consumption. In response to the rising trend, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) has established new guidelines on the global strategy for diagnosis, management and prevention of COPD. Systematic diagnosis and stratification are crucial for effective treatment measures. As COPD is an irreversible and progressive disease, its treatment aims an early detection and better management, which leads preventing progression. Disease management programs have shown that only patients who understand their exacerbation symptoms can benefit. Moreover, it is a major goal to improve health-related quality of life by reducing symptoms and decelerating disease progression. Spirometry is the golden standard for the diagnosis of COPD, to assess the severity of the obstruction, and as a guide for optimal therapeutic measures. Aim of the study The objective of this project is to establish a COPD cohort database to allow high quality research on diagnosis, treatment, complication and progression of COPD on long-term course. Spirometry should be used consistently for the diagnosis and the monitoring of the development of the disease. Using collected information such as spirometric data, disease progression's data and therapeutic measures should help improve the management and self-management of the patients. Methods 3.1 Study design We are conducting a prospective cohort study, based on COPD patients from northern and western Switzerland, who are managed under primary care setting. Patients with mild to very severe COPD (GLOD stages I-IV) are enrolled in the study. Currently, 67 General practitioners (GPs) are participating in our Study. Each GP recruits 1-20 patients with presumed mild to very severe COPD according to criteria of the Global Initiative for Chronic Obstructive Lung disease [GOLD]. Patients' follow-up-visits occurs at 6-month intervals; their history, symptoms and examination status is recorded. Data is entered into an online database either by the physicians or by study team after receiving the collected data questionnaires by facsimile. Data collection includes demographic data, physical examination, spirometric parameters, medical treatment and exacerbation history besides death. A spirometer (EasyOne™, ndd Medizintechnik AG, Zürich, Switzerland) is used to assess lung function. All participating physicians were instructed on the usage of the spirometer and on how to complete spirometry according to the guidelines. For the assessment of the severity of COPD, we use the spirometric data provided by the GPs. The COPD severity is interpreted according to criteria of the GOLD committee. 3.2 Patient population Patients with newly diagnosed or existing COPD, who are managed in primary-care practices. 3.3 Inclusion criteria Tiffenau (FEV17FVC) < 70 without reversibility (Increase in FEV1 after inhalation of a bronchodilator <200 ml and <12%). Age: > 40 years Both genders Smokers or ex-smokers of at least 20 pack years. Informed consent. 3.4 Archiving and Data Retention All study-related records such as medical records, informed consent documents, information regarding participants who discontinued, and other pertinent data will be maintained and therefore retained as long as required by the applicable Swiss regulatory requirements (10 Years). 3.5 Data security The complete data of the study will be entered anonymously into a database. The data is password-protected and can only be accessed by investigators and study members. Publication and authorship 4.1 Publication policy Authorship credit is based on: Substantial contribution to conception and design, acquisition of data, or analysis and interpretation of data. Drafting the article or revising it critically for important intellectual content. Final approval of the version to be published. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.

Start: September 2006

Assessing the Utility of Peak Inspiratory Flow as a Predictor for COPD Exacerbations

This is an international, mulitcentre, observational, prospective study into Peak Inspiratory Flow in COPD patients that aims to: A) Determine the prevalence of suboptimal Peak Inspiratory Flow (PIF) and inadequate inhaler choice and assess the baseline characteristics of these groups. B) Assess the clinical role of PIF and inhaler choice in predicting COPD exacerbations and symptom burden. C) Assess the variability and correlation of PIF with other lung function measurements and CAT score in stable COPD. It is a 12 month study comprising one baseline assessment and 2 follow-up visits at 6 and 12 months.

Start: December 2020

During-exercise Physiological Effects of Nasal High-flow in Patients With Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease is a major cause of disability and mortality worldwide. This disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation teaches chronic obstructive pulmonary disease patients to cope effectively with the systemic effects of the disease and improves exercise capacity, dyspnea and quality of life in patients with chronic obstructive pulmonary disease. However, the best training modality remains unknown. Physiological studies highlight the benefit of high intensity endurance training. However, many patients do not tolerate such a training due to ventilatory limitation and dyspnea. Therefore, a strategy to reduce dyspnea would allow a greater physiological muscle solicitation and improvement. Thus, many studies focus on means to increase exercise tolerance in patients with chronic obstructive pulmonary disease. Nasal high flow delivers heated and humidified high flow air (up to 60 L/min) through nasal cannula providing physiological benefits such as positive airway pressure and carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure. More recently, nasal-high flow has been shown to improve endurance exercise capacity in patients with chronic obstructive pulmonary disease. However, the underlying physiological mechanisms have not been yet elucidated but may help to optimise the utilization of the device. Therefore, the primary objective of this study is to assess the respiratory physiological effects nasal high-flow during-exercise in stable patients with chronic obstructive pulmonary disease. Secondary objectives are to assess the effects nasal high-flow during-exercise on endurance capacity, respiratory drive, dynamic hyperinflation, cardiorespiratory pattern and muscular metabolism.

Start: November 2019

6-minute Stepper Test and Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronicle Obstructive Pulmonary Disease

Start: August 2019

Rehabilitation for Patients With COPD

This study will examine COPD Wellness, a 10-week low-intensity pulmonary rehabilitation program consisting of group and home exercise, education, and social support can improve symptoms and increase physical activity in participants with COPD who receive care within a 'safety-net' healthcare system (e.g. County Hospital). Half of the participants will also receive an adherence strategy targeted at addressing unmet social needs, while the other half will undergo the intervention without the adherence strategy.

Start: September 2017

Comparison of the Cardiopulmonary and Gaz-exchange Response Between the Six-minute Stepper Test and the Incremental Cardiopulmonary Exercise Testing in Patients With Chronicle Obstructive Pulmonary Disease

Chronicle obstructive pulmonary disease is a worldwide cause of mortality and morbidity. This systemic disease progressively leads to dyspnea, muscle wasting and exercise capacity impairment. Pulmonary rehabilitation is a cornerstone in the management of these systemic effects. Unfortunately, access to pulmonary rehabilitation is limited for many people who would benefit from it, primarily because of a lack of pulmonary rehabilitation and assessment centers. Optimal assessment should include an incremental cardiopulmonary exercise testing. This test allows to evaluate the factors contributing to exercise intolerance by linking performance and physiological parameters to the underlying metabolism. Moreover, it is the standard test to determine both the optimal training settings as well as any cardiopulmonary contraindications to pulmonary rehabilitation. However, this test is not available in most centers and when it is, consultations are limited. Therefore, pulmonary rehabilitation is often delayed for several weeks and patients can lose motivation. In order to promote pulmonary rehabilitation, the incremental cardiopulmonary exercise testing could be replaced by field tests to individualize pulmonary rehabilitation prescription. The six-minute stepper test is a new field tool. Its sensitivity and reproducibility have previously been reported in patients with chronicle obstructive pulmonary disease. It is easy to set up in the clinical setting and could be used to individualize pulmonary rehabilitation. The main drawback when using field test is that they only provide a non specific assessement of the functional capacity because cardiopulmonary parameters and gaz exchanges are not monitored. Although the performance during the 6-minute stepper test is moderately related with the maximal oxygen consumption during the incremental cardiopulmonary exercise testing performed on a cycloergometer, a direct comprehensive comparison of cardiopulmonary parameters and gaz exchanges during these two tests have never been performed. Moreover, stepping is more closely related with activities of daily life (requiring a repetitive transition from rest to submaximal exercise intensity) than the maximal incremental exercise on cycloergometer and could provide further insight on the disability of patients during their usual activities, such as stair climbing (which is frequently avoided). Additionally, on-transient phase two oxygen consumption kinetic is particularly relevant because it evaluation is independent of the patient's motivation or criteria used to terminate exercise. Therefore, the aim of this study is to compare the cardiorespiratory parameters, the gaz exchanges and the maximality between the six-minute stepper test and the incremental cardiopulmonary exercise testing performed on a cycloergometer. The secondary objective was to compare the on-transient oxygen consumption phase two kinetic parameters (time constant, span and steady state) according to the severity of the disease.

Start: August 2019

Impact of Hypnosis Intervention on the Emotional Dimension of Dyspnea in Patients With COPD.

The purpose of the clinical study is to compare the effect of hypnosis intervention on the emotional dimension of the dyspnea during a pulmonary rehabilitation program to the pulmonary rehabilitation program alone. This study will determine if the hypnosis intervention will lead to better maintenance of benefits obtained than the original described method.

Start: October 2019

Nasal High Flow to Maintain the Benefits of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease Patients

Chronic obstructive pulmonary disease (COPD) is a major cause of disability and mortality worldwide. This systemic disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation effectively improves exercise capacity, dyspnea and quality of life in patients with COPD. However, its benefits progressively fade over time due to several factors such as the lack of regular exercise activity, dyspnea, airway secretions, hematosis impairment and acute exacerbations which can lead to hospitalization and accelerated muscle wasting. Nasal high flow (NHF) is a support used to deliver heated and humidified high flow air (up to 60 L/min) through nasal canula providing promising physiological benefits such as positive airway pressure or upper airway carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure. More recently, several studies have shown that long-term nasal high flow could contribute to improve exercise capacity, dyspnea, airway secretion removal, hematosis, reduced acute exacerbations and subsequent hospitalizations in patients with COPD. Based on these results, the primary aim of this study is to assess whether long-term nasal high flow treatment can help COPD patients to better maintain their endurance capacity following a course of pulmonary rehabilitation.

Start: July 2019

Advancing Understanding of Transportation Options

This Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers. This multi-site trial will (1) test the driving decision aid (DDA) in improving decision making and quality (knowledge, decision conflict, values concordance and behavior intent); and (2) determine its effects on specific subpopulations of older drivers (stratified for cognitive function, decisional capacity, and attitudinally readiness for a mobility transition). The overarching hypotheses are that the DDA will help older adults make high-quality decisions, which will mitigate the negative psychosocial impacts of driving reduction, and that optimal DDA use will target certain populations and settings.

Start: December 2019

Russian Current and Expiratory Muscle Training in COPD Patients

Respiratory muscles are essential to alveolar ventilation. In COPD, these muscles work against increased mechanical loads due to airflow limitation and geometrical changes of the thorax derived from pulmonary hyperinflation. Respiratory muscle fibers show several degrees of impairment in cellular and subcellular structures which translates, from the functional point of view, to a loss of strength (capacity to generate tension) and an increased susceptibility to failure in the face of a particular load. Expiratory Muscle Training was recommended to strengthen expiratory muscles and minimize exacerbations in addition to delaying deterioration with better functional capacity. Neuromuscular electrical stimulation (NMES) is emerging as a new rehabilitation modality for muscle strengthening that does not evoke dyspnea to obtain a benefit in patients who are unable to participate in a traditional rehabilitation program

Start: January 2021

Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation

This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in Veterans with chronic obstructive pulmonary disease (COPD) and insomnia receiving an Internet-based behavioral treatment for insomnia during home-based pulmonary rehabilitation (HBPR) versus those only receiving HBPR. Participants will undergo a sleep and health assessment that will be performed prior to the beginning of HBPR and at the end of HBPR and 6-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia plus HBPR or HBPR only.

Start: October 2021