Active clinical trials for "Pulmonary Disease, Chronic Obstructive"

The rationale of this study is to conduct a summative (i.e., validation) usability test of Ciprofloxacin Dry Powder for Inhalation (DPI) and the associated Instructions for Use.

Chronic obstructive pulmonary disease (COPD) is the third leading cause of the death in the US. The personal, social and economic costs of the disease are tremendous, with annual expenditures of nearly $50 billion, mostly from hospitalizations for exacerbations of COPD and associated sequelae. For the vast majority of patients, despite optimal pharmacological therapy, living with COPD is characterized by unrelieved dyspnea, physical inactivity, deconditioning, and an insidious downward spiral of social isolation and depression that has a profound impact on the lives of patients and their caregivers. There is mounting evidence that physical inactivity is significantly associated with more frequent hospitalizations and increased mortality in COPD even after adjusting for disease severity. While practice guidelines recommend regular physical activity for all patients with COPD, health systems are challenged in operationalizing an effective and sustainable approach to assist patients in being physically active. The investigators propose a pragmatic randomized controlled trial to determine the effectiveness of a 12-month physical activity coaching intervention (Walk On!) compared to standard care for 1,650 COPD patients from a large integrated health care system.

This study will demonstrate whether an end-of-life preparation and completion intervention reduces anxiety, depression, pain and other symptoms and improves functional status, spiritual well-being, and quality of life. If effective, the intervention offers a brief, inexpensive, and transportable non-physician treatment method for improving the experience of individuals in the latter stages of life-limiting illness.

The goal of the study is to evaluate a Home-Based Disease Management program specifically developed for patients with Gold III/IV COPD. By improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this Home-Based COPD Management Program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.

The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated. A placebo arm is included to evaluate these products compared to an inactive control.

Studies on resting human muscle show that ingestion of the branched-chain amino acids (BCAA): leucine, valine and isoleucine have an anabolic effect on muscle protein metabolism. However, the effects of BCAA intake on protein metabolism during exercise are less clear. When BCAA were supplied as single amino acids, without other amino acids and/or carbohydrates, no effects were observed on protein kinetics. On the other hand, ingestion of BCAA during running appeared to reduce the catabolic effect of running on muscle protein metabolism. These experiments were all performed with mixtures of the BCAA with or without carbohydrates but not in the form of complete meals with food protein as a basis. Therefore, it is still unknown whether a protein meal, containing a substantial amount of BCAA is beneficial during exercise by inducing an anabolic effect. Whey and Casein protein contain a substantial amount of BCAA in contrast to Soy protein. Therefore, it is hypothesized that milk-based proteins are a better and more physiological source of BCAA during exercise and will lead to more protein anabolism. Most of the available studies have been carried out in young and fit humans but there are hardly any data are available in the increasing population of the elderly. Therefore it is still unknown whether a BCAA rich protein meal can enhance the anabolic effect of exercise in older individuals. Besides sarcopenia, a substantial part of the elderly is suffering from a chronic systemic disease such as chronic obstructive pulmonary disease (COPD). COPD represents an important health care problem. COPD is the fourth leading cause of death and will be the third leading cause worldwide in 2020. Besides the local impairment, COPD is a chronic wasting disease, associated with alterations in intermediary metabolism. Substantial disturbances have been found in BCAA (and related) metabolism in these patients at rest and during exercise. It might therefore be of clinical relevance to study the metabolic effects of BCAA rich protein meals in patients with COPD at rest and during exercise.

This is a Phase I study to assess the combined effects of food and suppression of gastric acid secretion on the relative bioavailability of an immediate release (IR) tablet formulation and prototype bioenhanced formulations of GSK1325756, an oral interleukin 8 receptor (IL8R also known as CXCR2) antagonist. The objectives are to understand if the co-administration of food enhances absorption and the inter-subject variability for the current GSK1325756 IR tablet under fed state proton pump inhibitor (PPI) conditions and secondly to assess whether two proposed bioenhanced formulations offer any improvement over the current GSK1325756 IR formulation under PPI conditions. This open-label, randomized, 5-period crossover study will be completed in a single cohort of subjects, with an interim analysis after completion of Treatment Period 4. During Treatment Periods 1 to 4, subjects will be randomized to receive GSK1325756 50 mg IR in the fed state, GSK1325756 50 mg IR in the fasted state, GSK1325756 Bioenhanced Formulation 1 in the fasted state, and GSK1325756 Bioenhanced Formulation 2 in the fasted state. Progression to Treatment Period 5 and the choice of bioenhanced formulation for dosing in this treatment period will be dependent on the findings of an interim analysis of the pharmacokinetic profile and relative bioavailability of each formulation following completion of Treatment Periods 1 to 4. In Treatment Period 5, subjects will receive the selected GSK1325756 bioenhanced formulation in the fed state.

COPD patients have a reduced exercise tolerance due to a ventilatory limitation. Several studies have shown altered skeletal muscle function. The investigator will study the physiological response to knee-extensor exercise in COPD patients.

For complex medical patients, the transition from hospital to home-based care is a vulnerable period, placing the patient at high risk for adverse events. Using a Care Transition conceptual model, the investigators propose developing and evaluating, through a randomized controlled trial, "e-Coach," an Interactive-Voice-Response-supported (IVR) Care Transition coaching intervention, focused initially on patients hospitalized with heart failure or obstructive lung disease. This trial will test the primary hypothesis that the proportion of patients with one or more re-hospitalizations during a 90-day post-discharge follow-up period will be less in an IVRsupported care transition intervention (e-Coach) compared to a "usual care" comparison group.

The aim of this study is to test the feasibility of conducting a pragmatic fast track Randomized Controlled Trial (RCT) of the Breathlessness Intervention Service (BIS) versus standard care for patients with COPD and their carers, and to begin testing the effectiveness of the intervention.