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Emphysema clinical trials

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NCT ID: NCT02399514 Completed - COPD Clinical Trials

Improvement of Sleep Quality by RePneu® Coils in Advanced Pulmonary Emphysema

Start date: November 5, 2014
Phase: N/A
Study type: Interventional

Improvement of sleep quality in emphysema patients is desirable. Yet, there are no data of patients treated with RePneu coils. This monocenter prospective study investigates the effect on sleep quality of RePneu coils for reduction of dynamic hyperinflation in advanced disease stages of pulmonary emphysema. Patient's sleep will be studied in three Polysomnography measurement nights, one prior to Coil Treatment, one six months after, and one twelve month after. Primary objective is to investigate differences in sleep quality 6 and 12 months after Coil Treatment. Further endpoints are changes in daily activity and sleep (actigraphy), 6MWT, lung function parameters, and questionnaires (SGRQ, mMRC dyspnoe scale).

NCT ID: NCT02382367 Completed - Pulmonary Emphysema Clinical Trials

Prevalence of Alpha-1 Antitrypsin Dysfunction in Pulmonary Emphysema

DysA
Start date: December 2014
Phase: N/A
Study type: Interventional

The main objective of this trial is to evaluate the prevalence of alpha-1 antitrypsin quantitative and functional deficiency in an adult French population presenting with pulmonary emphysema. Phenotypic and genotypic studies will be carried whenever quantitative and/or functional deficiency will be displayed.

NCT ID: NCT02238327 Completed - HIV Clinical Trials

Longitudinal Evaluation of HIV-associated Lung Disease Phenotypes

LEAP
Start date: September 2014
Phase:
Study type: Observational

The overall hypotheses of this proposal are that discrete phenotypes of HIV Chronic Obstructive Pulmonary disease (COPD) differ in their trajectories, biomarkers, and risk factors and that persistent viral infection including residual HIV is linked to HIV COPD.

NCT ID: NCT02232841 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Electrical Impedance Imaging of Patients on Mechanical Ventilation

Start date: September 2014
Phase: N/A
Study type: Observational

The goal of this study is to evaluate the sensitivity and specificity of Electrical Impedance Tomography (EIT) as a bedside diagnostic tool for lung pathologies in patients who are mechanically ventilated. In electrical impedance tomography low amplitude, low frequency current is applied on electrodes, and the resulting voltage is measured and used to computed the electrical properties of the interior of the chest as they change in time. The computed properties are used to form an image, which can then be used for monitoring and diagnosis.

NCT ID: NCT02179125 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Identifying REsponders and Exploring Mechanisms of ACTION of the Endobronchial Coil Treatment for Emphysema

REACTION
Start date: March 2015
Phase: N/A
Study type: Interventional

Rationale: The PneumRx RePneu Lung Volume Reduction Coil (RePneu LVR-coil) is a bronchoscopic lung volume reduction treatment designed to compress the areas of lung parenchyma most damaged by emphysema. The LVRC treatment was found to be feasible, safe and effective in previous studies. However, patient-based outcomes besides quality of life questionnaires are hardly measured after intervention treatments for COPD. Furthermore, the exact underlying physiological mechanism of the LVR-coil treatment is unknown. Another aspect of the treatment which we to date do not fully understand is which group of patients benefit of the treatment and which group of patients do not, this knowing that the responder rate is already about 60%. Objective: The objectives of the study are to gain more knowledge on 1) the effect of the LVRC treatment on patient-based outcomes like physical activity, 2) the underlying physiological mechanism of the treatment, 3) the predictors of response to the treatment at baseline, and 4) on a targetted treatment number of coils to be placed per lung using lung compliance. Study design: This study is a non-randomised open label multi-center intervention study. Study population: The study population exists of adult patients with severe emphysema with no other treatment options left besides surgical procedures. Intervention: Bilateral bronchoscopic lung volume reduction treatment with RePneu coils. Main study parameters/endpoints: The main study endpoint is the change in physical activity between baseline and 3 months follow-up after the second treatment. The secondary endpoints are the changes between baseline and 3 months follow-up after the second treatment in: patient reported outcomes of the treatment, dynamic lung hyperinflation, static lung volumes, lung compliance, diaphragm function, lung perfusion, systemic inflammation and small airways function. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The LVR Coil has been designed to be as safe as possible. It was shown that the risks associated with the LVRC system are largely attributable to the bronchoscopic procedure itself rather than to the device per se. Therefore, it appears that the LVRC device itself does not appreciably increase the risk of serious adverse events beyond the risk of undergoing a bronchoscopy procedure or simply having emphysema. Currently, this treatment is not commercially available in the Netherlands and study participants will have to visit the hospital multiple times. Previous studies have shown that the treatment has beneficial effect for the patient, however not all patients respond. Part of this new study is to try to identify which group of patients respond to the treatment and which patients do not. Therefore, it is possible that a patient will not receive any benefits from the treatment.

NCT ID: NCT02107209 Completed - Pulmonary Emphysema Clinical Trials

Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema

BLVR
Start date: April 2013
Phase: Phase 2
Study type: Interventional

The clinical utility of bronchoscopic methods for achieving lung volume reduction has been evaluated in patients with advanced emphysema because these procedures are uniformly safer than surgical volume reduction. These include one-way valves, or bronchial occlusive devices to collapse emphysematous regions of lung and bronchial fenestration with bypass stents to improve expiratory flow, wire coils implants that compress the airway and thermal vapor ablation that causes an acute injury with subsequent fibrosis and reductions in volume.

NCT ID: NCT02100800 Completed - Emphysema Clinical Trials

Assessment of Emphysema Using 1.5T MRI With UTE Pulse Sequences

EMPHYREM
Start date: May 23, 2014
Phase: N/A
Study type: Interventional

Emphysema is a major pathological feature of Chronic Obstructive Pulmonary Disease (COPD). Non-invasive assessment of emphysema is a crucial issue for the phenotype and follow-up of COPD patients. Currently, CT is the method of reference to evaluate and quantify emphysema but it remains a radiation-based technique. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. Our objective is to evaluate emphysema in COPD patients using CT and MR-UTE, and to test the agreement between both techniques.

NCT ID: NCT02099799 Completed - COPD Clinical Trials

The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD

WEB
Start date: November 17, 2015
Phase: N/A
Study type: Interventional

COPD currently afflicts 24 million US residents; the prevalence of COPD is high among Veterans. Persons with COPD have significant functional disability as a result of the disease. This project will determine whether a novel Internet-mediated walking program coupled with a pedometer can improve exercise capacity, improve health-related quality of life, and decrease the risk of acute exacerbations in persons with COPD. If successful, based on estimates that 33 to 64% of COPD patients are Internet users, the proposed exercise intervention could help over 8 million persons. The Veterans Health Administration (VHA) has a strong commitment to providing care to persons with COPD and supporting research directed at COPD-related disability. The 2012-2016 Strategic Plan of the VHA Office of Research and Development includes research in COPD rehabilitation. The proposed research addresses Rehabilitation R&D Service's current priority area of improving disabled Veterans' health-related quality of life by reducing disease burden and maximizing functional recovery.

NCT ID: NCT02056158 Completed - HIV Clinical Trials

HIV+ Alveolar Macrophage Oxidant-mediated Apoptosis of Pulmonary Endothelium

Start date: January 13, 2014
Phase:
Study type: Observational

In HIV+ cigarette smokers, with no prior history of pulmonary infections, emphysema is often developed at an earlier age and is a significant cause of morbidity despite treatment with antiretroviral drugs. Preliminary data gathered from HIV+ individuals that smoke cigarettes strongly support the hypothesis that the combination of HIV infection and smoking creates increased stress in the lower respiratory tract. To examine the underlying factors that contribute to the accelerated development of emphysema in this cohort, samples from the lower respiratory tract will be provided by HIV+ and HIV- subjects. The samples collected will serve as biomarkers for assessing the onset of emphysema.

NCT ID: NCT02042976 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Mindfulness-based Cognitive Therapy for Chronic Obstructive Pulmonary Disease

Start date: February 2014
Phase: N/A
Study type: Interventional

The purpose of the study is to determine the efficacy of mindfulness-based cognitive therapy (MBCT) as an add-on to pulmonary rehabilitation (treatment as usual, TAU) in chronic obstructive pulmonary disease (COPD). The investigators hypothesize that compared to treatment-as-usual, the add-on of MBCT will result in improved psychological (anxiety, depression) and physical outcomes (physical health status, activity level, inflammatory markers). Furthermore, the investigators will explore the possible moderating role of individual differences in sociodemographic and disease-related characteristics and the perceived quality of the therapeutic alliance, as well as the mediating role of mindfulness, breathlessness catastrophizing, self-efficacy, and self-compassion for the hypothesised effect.