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Showing 1-20 of 126 trials
NCT02556697
Systemic sclerosis (SSc) is a generalized disorder of connective tissue, arterioles and microvessels, characterized by the occurrence of fibrosis and vascular obliteration phenomena. The alterations in lung microvessels are found in pulmonary involvement of scleroderma, which are the most serious complications of the disease. In pulmonary emphysema, there are also changes in pulmonary microvasculature, which are involved in the onset and development of the disease. The confocal endomicroscopy is an endoscopic technique which can be performed during a bronchoscopy. This technique makes it possible to observe in real time the most distal pulmonary elements at the microscopic scale. After injection of fluorescein, then the technique of observing the pulmonary microvasculature, in vivo and in situ. The characterization of microvascular lesions in these two pathologies could improve understanding of their mechanisms and ultimately improve the early management of patients.
NCT05949645
The goal of this clinical trial is to test the feasibility of an implant for severe emphysema in up to 30 participants at up to 5 study centers located in Europe and the United Kingdom. The main questions this clinical trial aim to answer are: Is it safe? Does it work? Participants who meet eligibility criteria will have up to two procedures 30 days apart, in which up to 3 implants will be placed in each lung during the procedure(s). Participants will be asked to return for follow-up visits at 30 days, and 3, 6, and 12 months after the procedure(s).
NCT05854550
The goal of this clinical trial is to test the feasibility of an implant for severe emphysema in up to 30 participants. The main questions it aims to answer are: Is it safe? Does it work? Participants who meet eligibility criteria will have up to two procedures 30 days apart, in which up to 3 implants will be placed in each lung during the procedure(s). Participants will be asked to return for follow-up visits at 30 days, and 3, 6, and 12 months after the procedure(s).
NCT05087641
The Pulmair Implantable Artificial Bronchus (IAB) is a device intended for implantation into the diseased bronchi of emphysema patients. The IAB is indicated for bronchoscopic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD)/emphysema to relieve hyperinflation and allow bidirectional ventilation of the affected lobes. The objective of this trial is to demonstrate a suitable benefit/risk profile to support a subsequent trial of the safety and effectiveness of the IAB to achieve its intended purpose. The trial will enroll 24 subjects implanted with IAB(s), at no more than three study centers.
NCT07119229
A study taking place at multiple sites in the United States, Europe and Brazil to evaluate how well a new therapy for severe COPD/emphysema works, and how safe it is.
NCT00683722
The objective of the present study is to establish the safety and efficacy of multiple administrations of Prochymal™(ex-vivo cultured human adult mesenchymal stem cells) in participants with moderate to severe chronic obstructive pulmonary disease (COPD).
NCT07326592
This is a multicenter, parallel-group, double-blind, randomized phase 4 study designed to identify the optimal dose of CE1226 (2 active doses) to slow disease progression as assessed by reduced rates of annual lung density decline in alpha-1 antitrypsin (AAT) deficient participants over 3 years as compared with the marketed dose 60 milligrams per kilogram (mg/kg).
NCT01983241
This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of an optional pre-screening phase, Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160.
NCT02796937
This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha1-MP 60 mg/kg/week in subjects with alpha1-antitrypsin deficiency (AATD).
NCT06361121
The ultrasound guided Thoracic paravertebral (TPV) block in the context of posterolateral thoracotomy offers targeted pain relief by anesthetizing the spinal nerves as they emerge from the intervertebral foramina, producing ipsilateral somatosensory, visceral and sympathetic nerve blockade. TPV block involves the injection of local anesthetic (LA) into the wedge-shaped paravertebral space deep to the superior costotransverse ligament (SCTL) Costach et al introduced the mid-point transverse process to pleura block (MTP) as a modification of conventional paravertebral block by placing the LA posterior to the (SCTL) under ultrasound guidence achieving an effective block without the necessity to approach the pleura and the attendant risks. In recent studies ,the ultrasound guided MTP block provided an effective analgesia in various surgical procedures including mastectomy , video-assisted thoracic surgeries and cardiac surgeries. In our study we hypothesized that the mid-point transverse process to pleura (MTP) block can provide an effective analgesia comparable with thoracic paravertebral (TPV) block in adult patients undergoing posterolateral thoracotomy incisions.
NCT04517916
The objective of this Registry is to provide ongoing safety and effectiveness assessment of the Zephyr Valve treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD) Grade III and Grade IV in order to support the renewal of the inscription of the Zephyr Valve on the list LPPR (Art 165-1) in France.
NCT06891755
The objective of this study is to assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment. The Apreo BREATHE Airway Scaffold is a permanent implant designed to tent open native airways. The study will include up to 250 participants at up to 25 study centers located in the United States and Europe. Study subjects will be followed for 3 years. The main questions it aims to answer are: Is it safe? Does it work?
NCT05382208
The purpose of this study is to determine if doxycycline will reduce progression of emphysema in people living with HIV. The secondary objectives are to examine the effects of doxycycline on change in quantity of emphysema, six minute walk distance, patient reported outcomes, ratio of forced expiratory volume in 1 second and forced vital capacity. Secondary objectives will also describe the safety and tolerability of doxycycline and determine if doxycycline is associated with development of antibiotic-resistant bacterial infections.
NCT03500731
The purpose of this study is to determine whether a lung transplantation prior to bone marrow transplantation (BMT) would allow for restoration of pulmonary function prior to BMT, allowing to proceed to BMT, to restore hematologic function.
NCT02439528
The combined pulmonary fibrosis and emphysema syndrome (CPFE) individualized by our group in 2005 is characterized by an often severe dyspnea, almost exclusive male predominance, and often major, profound impairment of gas exchange contrasting with preserved lung volumes and absence of airflow obstruction, and a high risk of pre-capillary pulmonary hypertension responsible for increased mortality. Almost all patients are smokers or ex-smokers. There are some arguments in favor of genetic abnormalities in this syndrome of unknown etiology (other than smoking) including short telomeres and mutations in the telomerase complex genes. There are also emphysematous lesions, in patients with familial pulmonary fibrosis, with mutations in the SFTPC gene (surfactant protein C), and reported cases of CPFE syndrome with SFTPC mutation. No large genetic studies have been conducted to date in the CPFE syndrome. Our main hypothesis is that the proportion of subjects with short telomeres is higher among patients with CPFE syndrome than in subjects of similar age with idiopathic pulmonary fibrosis but without emphysema. It has previously been shown that mutations in the telomerase TERT or TERC genes are mostly found in people whose telomeres are abnormally short. The investigators propose to use that test to identify patients most likely carrying a mutation, and to seek, among them, the mutations in the TERT or TERC telomerase genes. The objective of the study is to compare the proportion of patients with short telomeres in the group of patients with CPFE syndrome to that of other patients (with idiopathic pulmonary fibrosis without emphysema, or with emphysema without fibrosis).
NCT01969344
SPIROMICS I, SPIROMICS II, and SPIROMICS III are longitudinal observational studies of Chronic Obstructive Pulmonary Disease (COPD) cohort. SPIROMICS I had two primary aims: (1) To find groups of patients with COPD who share certain characteristics; (2) To find new ways of measuring whether or not COPD is getting worse and to provide new ways of testing whether a new treatment is working. SPIROMICS II had three primary aims: (1) To define the natural history of "smokers with symptoms despite preserved spirometry" and characterize the airway mucus abnormalities underlying this condition; (2) To determine the radiographic precursor lesion(s) for emphysema and identify the molecular phenotypes underlying airway disease and emphysema; (3) To advance understanding of the biology of COPD exacerbations through analysis of predisposing baseline phenotypes, exacerbation triggers and host inflammatory response. SPIROMICS III has three primary aims: (1) To identify the main forms of smoking-related airway disease that are caused by pathological airway mucus, their biological underpinnings, and their physiological significance; (2) To identify longitudinal trajectories in established and novel CT measures of emphysema, test how they predict COPD progression, and define their underlying biology; (3) To identify environmental and social determinants of health that impact disease severity and progression and their influence on lung structure, biology, and health disparities in COPD.
NCT07059637
Sarcopenia, or skeletal muscle loss, impacts up to 40% of COPD patients and is a major cause for morbidity and mortality. Despite the high clinical significance of sarcopenia in COPD, the diagnosis remains elusive because accurate measures of skeletal muscle are not tested during routine clinical care. The goal is to use evidence-based strategies to diagnose and treat sarcopenia due to COPD. The multidisciplinary team includes a pulmonologist, pharmacist, COPD nurse, and COPD coordinator. The investigators anticipate that the approach will improve clinical outcomes for COPD patients with sarcopenia as compared to standard of care visits in ambulatory COPD clinics. The investigators will determine if the approach improves skeletal muscle mass and function, and also improves clinical outcomes related to frequency of hospitalization or ED (Emergency Department) visits, COPD exacerbations, and mortality.
NCT06149494
Vapendavir (VPV) is a drug being developed to treat human rhinovirus (RV) infection, one virus responsible for the common cold. Vapendavir prevents the virus from entering cells and making more infectious copies of itself. A study is being planned to investigate VPV in patients with chronic obstructive pulmonary disease (COPD, a lung disease making it difficult to breathe) who develop a rhinoviral infection; however, VPV has not been approved for use in treating any indication (disease) by the FDA or any other global regulatory agency. Therefore, VPV is considered investigational, and the study doctor is conducting this investigational research study. Safety will be monitored throughout the entire study.
NCT00307281
The Comprehensive Lung Center (CLC) at the University of Pittsburgh Medical Center (UPMC Health System) provides patients with any type of breathing or lung disorder a full range of diagnostic and therapeutic services. The Emphysema/COPD Research Center (ECRC) is a specialty clinic, within this center, that attempts to advance the understanding of emphysema and to evaluate new therapies for patients with emphysema. The Emphysema Research Registry will enable pulmonary research physicians to: 1) gather information and create a research registry of people who have been diagnosed with emphysema; 2) utilize this research registry with the purpose of conducting research that attempts to advance the understanding of emphysema and to evaluate new therapies; and, 3) use the research registry to identify potential candidates for future research programs. These aims will be achieved by the collection of DNA (genetic material)for analysis and storage in addition to pulmonary function tests and other medical information.
NCT00870857
Despite the availability of highly active antiretroviral therapy (HAART), lung diseases remain a leading cause of morbidity and mortality in those with HIV infection. There have been no large-scale studies detailing pulmonary complications in the HAART era. Substantial gaps exist in our knowledge of the spectrum and pathogenesis of pulmonary disorders in this population, particularly in women and minorities whose numbers with HIV or AIDS have increased. The Multicenter AIDS Cohort Study (MACS) and the Women's Interagency Health Study (WIHS) are prospective, multi-center cohorts that follow approximately 5000 HIV+ subjects and HIV- controls. Although pulmonary disease has not been an area of focus, these established cohorts provide a unique opportunity to systematically study pulmonary complications of HIV infection. Emphysema is of particular interest in the current HIV era because it is likely to increase as this population lives longer with chronic HIV. HIV-infected persons have an increased incidence of emphysema compared to those without HIV infection, and it has been hypothesized that this accelerated disease progression is the result of one or more latent infectious agents that amplify the pulmonary inflammation. Accelerated emphysema was described in HIV infection in a predominantly male population before HAART. The current prevalence and characteristics of HIV-associated emphysema, and the potential impact of gender, have not been rigorously defined.