View clinical trials related to Lung Diseases, Obstructive.
Filter by:This multi-center study is designed to describe natural history of disease, treatment and health care products in physician-diagnosed COPD patients who require adding daily maintenance therapy in real world. The study planned to enroll 550 patients in Indacaterol group and 9450 patients in non- Indacaterol group, a total of 10,000 patients. Enrollment was stopped at 2253 patients due to low recruitment in indacaterol group. Finally a total of 2229 patients were analyzed in full analysis set. A total of 2253 patients entered into the database, of which 24 patients were exclude during the data review meetings, because they did not met the inclusion/exclusion criteria. Hence a total of 2229 patients enrolled successfully.
The purpose of this research study is to examine the effects of two weeks of daily dosing of inhaled salt water mist (hypertonic saline - HS) on actual measurements of mucociliary and cough clearance in patients with the chronic bronchitis type of Chronic Obstructive Pulmonary Disease (COPD. Defective mucociliary clearance (MCC) is central to the development and/or worsening of several kinds of lung diseases, including COPD/chronic bronchitis (CB), cystic fibrosis (CF), and bronchiectasis. In each case, defective MCC leads to the development of lung infections and damage to the airways from ongoing inflammation caused by a person's inability to clear mucus from the lungs. The investigators' previous studies have shown that the administration of inhaled HS (hypertonic saline) not only acutely accelerates MCC in CF, but also that repetitive use "resets" the baseline rate of MCC within 2 weeks. It is likely that the sustained effect of HS on MCC was responsible for the ~60% reduction in the frequency of pulmonary disease exacerbations, reduced antibiotic use and improved lung function in a long-term study of HS in CF volunteers. As a result, HS has now become a standard therapy for CF lung disease and its success raises optimism that similar benefits might occur in patients with CB. In this study the investigators will use mildly radioactive particles, technetium bound to sulfur colloid, to measure and compare the sustained effects on mucus clearance of two weeks of daily dosing of 7% hypertonic saline versus a low salt control treatment for subjects with CB. We will also be collecting sputum and breath condensation to analyze for protein and inflammatory changes that might occur with exacerbations. Our long term goals are to improve our understanding of MCC in health and disease and to develop better therapies that support and/or restore MCC in patients with these diseases to reduce lung infections.
The purpose of the research (or "knowledge gap" this research is designed to fill) is to understand the science of how the combination therapy of 2 drugs (inhaled longacting beta-agonists(LABA) and inhaled corticosteroids (ICS), which are commonly used in chronic obstructive pulmonary disease (COPD) patients, is better than each drug alone. ICS and LABA both have antiinflammatory properties; that is, they dampen the inflammation in the cells of the airways in the lungs. The combination of LABA and ICS has also been shown to improve clinical effectiveness in asthma patients. The addition of a LABA to LOW doses of ICS has been shown to be more clinically beneficial in asthma than the use of HIGH doses of ICS alone. This has allowed a reduction in the total ICS dose and minimised the adverse side effects of inhaled corticosteroids. Recent evidence suggests that the use of combination therapy of LABA and ICS may also improve clinical effectiveness in COPD patients. Investigators will address this hypothesis by examining the inflammation cells of COPD direct from the site of disease (the airways) by looking at sputum/mucus. This research will build on the existing knowledge of the science of how these drugs work in asthma and COPD and allows us to understand the molecular science, which may support new future drug targets for patients with COPD, which are greatly needed.
The purpose of this study is to determine whether resistance exercise are effective in combating the decline in muscle strength during an exacerbation of Chronic Obstructive Pulmonary Disease (COPD).
The COPD Research Registry is a confidential database of individuals diagnosed with COPD or at risk of developing COPD. The Registry was established in 2007 by the COPD Foundation with the purpose of providing a mechanism for researchers to boost enrollment in clinical trials and other research studies. The COPD Foundation is working with National Jewish Health in Denver, Colorado to serve as the Registry's Data Coordinating Center and to ensure strictest confidentiality of participant information.
Background: The efficiency of Neural respiratory drive (NRD)expressed by a ratio of ventilation to the diaphragm electromyogram (EMGdi) decreases in patients with COPD .Improving the neural respiratory drive efficiency of COPD will help to relieve the clinical symptom and make the patients feel comfort.Noninvasive positive pressure ventilation(NPPV)is a good treatment to AECOPD patients.It is unknown the effects of different mode of noninvasive positive pressure ventilation(NPPV) such as proportional assist ventilation (PAV) and pressure-support ventilation (PSV) on the efficiency of Neural drive of AECOPD and which mode benefit the patients more. Objective: To compare the short-term effects of mask pressure support ventilation (PSV) and proportional assist ventilation (PAV) on Neural respiratory drive in recovering patients of AECOPD
This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.
Many individuals with chronic lung disease have night time symptoms that disrupt their sleep. The purpose of this study is to determine the effects of an air purifying device (PureNight, Halo Innovations, Minneapolis, MN) on sleep disruptions measured by a "sleep watch" (actigraph) and individual perception of sleep quality.
A growing body of evidence suggests that in individuals with chronic lung disease their walk speed is related to their daily function and quality of life. It is possible to assess their usual (routine) and fast walking speeds by getting them to walk in a flat hallway. In individuals with chronic lung disease, we anticipate that their usual walk speed will be helpful in exercise prescription and use in multidimensional scoring systems. However, it is important to first determine the measurement properties of these two walk speeds.
Pneumonia remains an important cause of morbidity and mortality in older adults with obstructive lung disease. Risk factors for pneumonia, including episodes associated with a hospital admission, have been extensively characterized in clinical trials and observational studies of patients with COPD, and include older age, lower predicted FEV1 (<50%), prior COPD exacerbations, dyspnea , normal to low body mass index (<25), current smoking and certain co-morbid conditions (e.g. dementia). The use of inhaled corticosteroids (ICS) has also been identified, as associated with an increased risk of pneumonia in patients with COPD. The primary objective of this study is to estimate the magnitude of known risk factors and the outcomes of pneumonia requiring hospitalization and the potential effect modification of these risk factors by ICS use. The primary endpoints will be severe pneumonia, defined as community-acquired pneumonia (CAP) resulting in hospitalization and/or death and hospital-acquired pneumonia (HAP) diagnosed after two days in the hospital. As a secondary endpoint, CAP that did not result in hospitalization or death will be examined. As a secondary objective, we will describe characteristics for those patients who develop pneumonia requiring hospitalization compared to those with pneumonia not requiring admission. This study will use the General Practice Online Database (GOLD), formerly referred to as the General Practice research Database (GPRD), a primary care electronic medical record database. A new user cohort will be defined among patients with COPD who are 45 years and older in the United Kingdom. Patients will be considered a new user of ICS-containing medications if they had not received a prescription for an ICS-containing medication in the prior year. The comparator treatment group will be new users of long-acting bronchodilators (LABD), including long-acting beta-agonists (LABA) or long-acting antimuscarinics (LAMA). In the one year washout period, all new users could not have either ICS-containing medications or LABD. Prior to conducting the analysis, feasibility analyses will be conducted to evaluate of the number of pneumonia events and the number of new users separately to examine the available precision based on the study design. Patients will be followed from the date of their first eligible prescription (Cohort Entry Date) until the earliest of the following: date of study end point (first pneumonia event of interest), date of treatment end (up to 60-day gap allowed for each inhaler), date of transfer to a new practice, date of ICS initiation (among LABD new users), death or study end (end of available data). As part of the primary analysis, patients will be examined for their first severe pneumonia (severe CAP, HAP). As a secondary analysis, time to non-severe CAP will be examined. Incidence rates of the pneumonia outcomes will be calculated as the number of patients experiencing an event divided by the person-years at risk. Multivariable analysis will be performed using Cox proportional hazard model with adjustment for confounders and medication exposure. To adjust for differences confounding by severity due to differences in prescribing between ICS-containing medications and LABD, propensity scores (PS) will be utilized using inverse probability of treatment weighting (IPTW). The propensity score will be estimated to model the probability of a patient receiving ICS-containing medication prescription versus receiving a LABD prescription given a patient's observed set of baseline covariates. Effect modification (statistical interaction) will be evaluated based on available theory and include ICS medication use by known risk factors for pneumonia (BMI<21, BMI 21-24.9, BMI ≥25, age, GOLD stage III/IV, MRC dyspnea score ≥4, history of pneumonia diagnosis, current smoking status, social deprivation quartiles). Additional interactions may be evaluated. To test proportionality of the hazard functions, model diagnostics will be performed. To compare severe pneumonia with non-severe pneumonia in patients with COPD, characteristics of patients experiencing non-severe CAP vs. severe CAP or HAP will be tabulated. To assess differences between treatments, clinical and patient characteristics will be compared using the chi-square tests or Wilcoxon tests for categorical or continuous data, respectively. Severe CAP and HAP may be combined. Modeling of clinical and patient characteristics may be considered using logistic regression using CAP vs. severe CAP and then with severe CAP vs. HAP. Additional analysis or adjustments to the analytic or modeling strategy will be performed if the data warrants. A more detailed modeling strategy, including generation of the propensity scores and Cox modeling, will be created in a separate analysis plan. Adjustments to the a priori plan will be described in the final study report.