Active clinical trials for "Pulmonary Disease, Chronic Obstructive"

The objective of this study is to test the effect of High Molecular Weight Hyaluronic Acid (HMW-HA) on Non Invasive Ventilation (NIV) effectiveness in patients admitted to a sub-intensive care unit for respiratory failure due to acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).

Over time, patients with COPD (Chronic Obstructive Pulmonary Disease) develop progressive symptoms of breathlessness, which can limit day-to-day activities and tolerance to exercise. Pulmonary Rehabilitation (PR) is an established intervention in the management of COPD and is a structured programme of exercise training and education. Pulmonary Rehabilitation encourages and enables patients to improve their exercise capacity incrementally over the course of a six-week programme. An established evidence base has placed PR at the centre of interventions for COPD and its provision is mandated by NICE as a key pillar of integrated care. Currently, the provision of PR in the NHS is limited to group sessions run over an established protocol of 6 weeks. Whilst this has been demonstrated to improve exercise capacity, access to PR classes can be problematic for some patients. Also, staff and facility resources limit delivering the programme at scale. An online PR programme developed by my mhealth known as 'myPR', in consultation with patients and physiotherapy experts, offers an alternative provision of this important intervention. The study aims to compare this online PR programme to conventional face-to-face PR as currently delivered by the NHS. The study aims to recruit 106 patients referred for PR from Portsmouth Hospital and local Participant Identification Centres.They will then be assessed for suitability onto PR, consented and randomised onto an arm of the study. 36 will undertake a conventional PR programme as reflected in the NHS, and 70 the online PR programme known as 'myPR'. Pre and post programme measurements including walking distance and quality of life questionnaires will then be compared between each arm of the trial, to ensure that the online PR is not inferior to the conventional face-to-face PR.

Rationale: Application of long-term non-invasive ventilation (NIV) in stable chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure (CHRF) has recently been shown to improve survival and quality of life when applied with sufficiently high inspiratory pressures and adequate backup breathing frequencies (so called high-intensity NIV). However, for a broader implementation of this therapy in a potentially large group of patients, important issues have to be solved. First, the initiation of high-intensity NIV, currently performed in the hospital, is often time-consuming, expensive and inconvenient for patients. Secondly, although clinicians recognise that not all patients benefit, it is not known which factors predict a positive response. Objectives: To investigate whether home initiation of chronic NIV in stable COPD patients with CHRF is non-inferior to inpatient initiation. To investigate predictors of a favourable response to chronic NIV in COPD patients with CHRF. Study design: The study is 1:1 two-arm parallel group randomised controlled trial comparing the usual inpatient NIV initiation to home initiation. Study population: Seventy-two COPD patients with a NIV indication (COPD GOLD stage III or IV; partial arterial carbon dioxide pressure (PaCO2) > 6.0 kPa in stable condition, i.e. no COPD exacerbation for 4 weeks and a pH > 7.35), a sufficient social network at home, without severe cardiac comorbidities, will be included. Intervention: Home initiation of NIV will be compared with standard in-hospital initiation. NIV at home will be titrated by a specialised nurse of our home mechanical ventilation centre (HMV) on transcutaneously measured gas exchange and respiratory electromyography and will be adjusted with the use of telemedicine. Main study parameters/endpoints: To investigate non-inferiority of home initiation, the change in arterial carbon dioxide pressure after 3 months treatment will be the primary outcome. Secondary outcomes are safety, change in lung function, health-related quality of life (HRQoL) and costs. To investigate predictors of a favourable response, patient demographics, and baseline data on lung function as well as measures of respiratory muscle activity, arterial blood gases, comorbidities, inflammatory blood markers and anxiety and depressions scores will be collected of all patients.

The aim of the present study is to evaluate the superiority of the fixed triple therapy with BDP/FF/GB at a daily dose of 400/24/50 mcg respectively with that of Ultibro® Breezhaler® (DPI), fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg in COPD patients.

A placebo-controlled trial to determine whether recent ex-smokers with COPD who successfully stop smoking after taking varenicline are less likely to relapse back to smoking if they continue using varenicline for a further 12 weeks

Respiratory muscle weakness and fatigue are related to clinical deterioration in patients with Chronic Obstructive Pulmonary Disease (COPD). Respiratory muscle training (RMT) is a key therapeutic strategy in these patients. It is necessary therefore to increase its dissemination on a large scale, improve patient´s adherence and optimize the control of the implementation of training. The aim of this project was to design a RMT device including light and sound incentives, digital registration application and analysis of the training sessions, and studying the effectiveness of a new shortened RMT scheme of high intensity that could provide added value to enhance the implementation of training in patients with COPD. From an operational point of view, researches were organized into three packages of complementary work focused on the design of a new portable dual valve with electronic lighting and auditory incentives components. The conceptualization and design of a software to analyze the performance and individual continuous use of the valve, and the evaluation of the feasibility, safety and efficacy of a shortened schedule of respiratory muscle training in adult patients with COPD were realized.

This phase IIb randomized trial studies how well cholecalciferol (vitamin D3) supplementation works in strengthening inspiratory muscles in cholecalciferol-deficient patients with chronic obstructive pulmonary disease (COPD). Cholecalciferol supplementation may help reduce the risk of developing lung cancer and strengthen the diaphragm in cholecalciferol-deficient patients with COPD.

The study assessed the safety and ability of several doses of an orally inhaled medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered with an electronic eFlow nebulizer system in patients with Chronic Obstructive Pulmonary Disease (COPD). The study was conducted in 12 patients in 2 parts. Part 1 was designed to find the once-a- day GIS dose that produced the highest improvement in lung airflow. Part 2 tested the GIS dose with the highest improvement in lung airflow and a placebo (ie, no drug) delivered by a general purpose nebulizer. The airflow improvements of the same GIS dose were compared between the two nebulizer systems to determine what effect the device had on GIS delivery.

The aim of study is to determine if 99mTc Annexin V-128 (AxV- 128/Tc) single photon emission computed tomography (SPECT)-computed tomography (CT) can detect perioperative lung injury. The investigators will study patients undergoing major surgery, specifically Whipple procedures (pancreatico-duodenectomies) and compare AxV-128/Tc SPECT-CT scans before and after surgery in Chronic Obstructive Pulmonary Disease (COPD) and non-COPD patients.

The main purpose of the present study is to verify whether, as compared with conventional-intensity noninvasive positive pressure ventilation, high-intensity noninvasive positive pressure ventilation may more effective in correcting hypercapnia, hence reducing the need for intubation and improving survival in patients with acute exacerbation of chronic obstructive pulmonary disease.