View clinical trials related to Pulmonary Emphysema.
Filter by:Lung emphysema is often associated with chronic obstructive pulmonary disease (COPD) and without any cure. Dyspnea is the main, debilitating symptom and is relieved by inhaled bronchodilators and rehabilitation. However, a substantial number of patients continue to suffer from dyspnea and among these, many patients have severely hyperinflated lungs due to predominant emphysema. For selected patients, lung transplantation or lung volume reduction by surgical removal (LVRS) of the most emphysematous parts of the lung can improve symptoms and survival. However, LVRS is related to complications and not all patients are suitable for surgery. An alternative to LVRS is bronchial lung volume reduction with endobronchial valves (EBV). One-way valves are inserted in the bronchial system using a bronchoscope and it has emerged as a valid treatment option with similar effects as LVRS with reduction of hyperinflation and increasing pulmonary function, quality of life, and exercise capacity. The normal lung is colonized with several types of bacteria, and together this is called the microbiome. Some bacteria are potentially beneficial, while others are potentially harmful. After the insertion EBV, some patients develop chronic infections. The hypothesis is that the microbiome can affect the risk of this chronic infection, and therefore the objective of this study is to access the microbiome during the insertion of the EBV, and afterwards observe which patients develop chronic infection and if these patients are harbouring specific types of bacteria.
Rationale: Pulmonary emphysema is a component of Chronic Obstructive Pulmonary Disease (COPD) characterized by chronic inflammation with neutrophils and monocytes mediating the tissue destruction under the regulation of various types of lymphocytes. Bone marrow-derived mesenchymal stromal cells have potential to halt the progressive inflammatory response as indicated by the investigator's pilot study (CCMO NL28562.000.09) . Objective: To determine whether patients with emphysema develop anti-inflammatory and tissue repair responses by treatment with allogeneic bone marrow-derived mesenchymal stromal cells (MSC) from healthy donors. Study design: an explorative double-blind, placebo-controlled randomized (2:1) trial in 30 patients with moderate to severe emphysema who are scheduled for two separate sessions for surgical lung volume reduction (LVRS). The study treatment is intravenous allogeneic MSC or placebo treatment in between the first and second surgical session. Randomisation will allocate 10 patients to receive 2 x 106 /kg body weight MSC in a range of 1.5 x 106 MSC/ kg to 2.5 x 106 MSC/ kg (at a maximum of 200 x106 MSC per study participant) iv (or 5 patients to receive placebo) at week 4 and 3 before the second LVRS, and will allocate 10 patients to receive 2 x 106 /kg body weight MSC in a range of 1.5 x 106 MSC/ kg to 2.5 x 106 MSC/ kg (at a maximum of 200 x106 MSC per study participant) iv (or 5 patients to placebo) at week 12 and 11 before the second LVRS. Main study parameters/endpoints: the study has a co-primary endpoint. First, the difference in expression of CD31 on cells per micrometer alveolar septae present in lung tissue harvested at the second LVRS from patients who received MSC at 3 and 4 weeks prior to LVRS2 or placebo. Second, the difference between MSC and placebo treatment in change in CO diffusion capacity over a period of 3 years following LVRS2.
Background Numerous surgicals treatments have been described for the massive subcutaneous emphysema; however, some of these techniques cannot be carried out in a critical care unit and they are related with high morbidity and exposure in positive SARS COV-2 patients. More effective, less invasive and isolated procedures should be implemented. Technique Negative pressure therapy (NPT) that can allow effective solving of massive subcutaneous emphysema in a short period (5 days) with a minimally invasive approach at the bedside in Covid-19 or non infected critical patients. Conclusion NPT is an effective and low invasive strategy for the management of EES in critical patients with high risk of mortality.
The purpose of this protocol is to perform a pilot prospective randomized controlled clinical trial to evaluate the potential role of lung fissure completion strategy (experimental intervention) in addition to endobronchial valve (EBV) placement (representing "standard-of-care") in select patients with severe COPD/emphysema and with evidence for <95% fissure completion between adjacent lung lobes. In select patients, lung fissure completion strategy will be performed by either video-assisted thorascopic surgery (VATS)-guided or robotic-guided stapling along the lung fissures in an attempt to reduce collateral ventilation and determine whether or not this experimental strategy will improve outcome following subsequent EBV placement. EBV placement will follow successful VATS-guided or robotic-guided fissure stapling. The study will enroll approximately 20 patients at BIDMC, and outcomes will focus on procedure-related complications, physiological measurements (ex., FEV1 by pulmonary function testing) and clinical symptoms (i.e., questionnaires). Patient will be followed for 3-month period, receiving usual standard of care during the 3 months of follow-up. The goal of this protocol is to determine if elimination of significant collateral lung ventilation between lung lobes is possible, and whether such strategy to eliminate collateral lung ventilation between lobes improves outcomes following subsequent EBV placement (i.e. promotes atelectasis of diseased lung segments) in the management of severe COPD/emphysema in appropriate candidates. For subjects in the medical management control group, upon completion of the 3-month F/U period, they will be eligible for EBV if they choose.
This is a prospective randomized clinical trial comparing surgical and bronchoscopic lung volume reduction in patients with advanced homogeneous emphysema suitable for both procedures.
The hypothesis is that in patients with emphysema, a high MMP12 sputum and/or blood level correlates with airspace enlargement and with increased sputum Th2 immune biomarkers.
The purpose of this study is to evaluate the safety and the effects and of the application of Expiratory Positive Airway Pressure (EPAP) device on Dynamic Hyperinflation and dyspnea in patients with Emphysema and pulmonary bullae.
This is a prospective, open-label, multi-center, single-arm study to be conducted at up to 20 investigational sites. The Study plans to enroll up to 140 subjects with severe emphysema and collateral ventilation in the target lobe. This protocol is designed to evaluate the utility of the AeriSeal System to occlude collateral air channels in a target lung lobe with collateral ventilation (CV) and convert the target lung lobe to having little to no collateral ventilation. Subjects can then receive Zephyr Valves to achieve atelectasis in the targeted lobe, once AeriSeal has converted the CV+ lobe to a CV- one. Therefore, the study will have two Stages: • Stage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to block collateral ventilation (CV) with the AeriSeal System; conversion of the CV+ target lobe to CV-. Conversion of collateral ventilation will be evaluated by Chartis after 45 days. In the case of unsuccessful conversion, a second treatment of AeriSeal may be attempted, provided that the total application volume from both the initial and the repeat treatments does not exceed 40 mL in up to three (3) segments. Clinical Assessments post-AeriSeal will be conducted at 28 and 45 days after first treatment and repeated after the second treatment, if applicable. For the purpose of protocol follow-up, the Day 45 post-AeriSeal final treatment will equal Day 0 for Stage 2. • Stage 2 will include successfully converted subjects; CV+ to CV- conversion in Stage 1. Converted CV- target lobes will follow standard of care and receive CE marked Zephyr Endobronchial valves per the Zephyr IFU to perform bronchoscopic lung volume reduction (BLVR). Clinical assessments will be conducted at 45 Days, 3-months, 6-months, and 12-months post-Zephyr Valve procedure.
The investigators plan to perform a randomized controlled trial that compares bilateral lung volume reduction surgery (LVRS) with bronchoscopic lung volume reduction (BLVR) using endobronchial valves in terms of efficacy and patient safety.
Patients with severe emphysema have limited options for treatment. Current treatments include lung transplant, lung volume reduction surgery or endobronchial lung volume reduction using valves or coils. These options are only available for a small and selected group of patients. The Free Flow Medical Lung Tensioning Device System (LTD) is thought to be the next generation endobronchial treatment for patients with severe emphysema designed to address this unmet need. The LTD is designed to compress the areas of lung parenchyma most damaged by emphysema and to tension surrounding tissue to help restore lung elastic recoil in a similar manner to the lung volume reduction coils.