Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD
NCT05607719 · Chronic Obstructive Pulmonary Disease
RecruitingThe study objective is to determine whether an ICS added for 4 weeks to a baseline treatment with a Long-Acting Beta-adrenergic Agonist (LABA) and Long-Acting Muscarinic Antagonist (LAMA) combination improves pulmonary vascular endothelial function as assessed by the vasodilator response to inhaled albuterol (endothelium-dependent vasodilation) in stable COPD patients treated with a LABA/LAMA without an ICS for at least one month.
PhasePhase 2
TypeInterventional
Age40 Years – 80 Years
WhereMiami, Florida, United States
SponsorUniversity of Miami
▾Tap for detailsClick for full details — eligibility, all locations, contacts The Effect of Education and Reminder Messages on the Fatigue Level of Individuals With COPD
NCT06286072 · Copd, Fatigue
RecruitingCOPD is an important respiratory system disease that progresses with damage to the airways.Increased mucus secretion and thickening in the airways causes obstruction.This obstruction causes symptoms such as shortness of breath, cough, phlegm and wheezing.The most obvious problem that the emerging symptoms will cause for the patient is fatigue.Coping with fatigue is an important problem in COPD. The main questions it aims to answer are: 1. Does the training given in COPD affect the level of fatigue? 2. Do the education given and text messages sent regarding COPD affect the level of fatigue? In this study, patients were given informative education about COPD and ways to cope with fatigue were explained. Then, in order to increase the permanence of the training, motivational messages and short briefings were continued for 8 weeks.2 messages were sent per week. Three groups were created to reveal the effectiveness of the trainings and messages. Group 1 was trained and messages were sent for 8 weeks. Group 2 was trained and no message was sent. Group 3 is the control group. No training has been provided other than routine maintenance. The initial information of all groups was taken again at the end of the 8th week. Main outcomes: * Dyspnea severity, * COPD general conditions and * Fatigue level. The results obtained will be interpreted by comparing between 3 groups.
PhaseNA
TypeInterventional
Age18 Years – 85 Years
WhereKırşehir, Center, Turkey (Türkiye)
SponsorKirsehir Ahi Evran Universitesi
▾Tap for detailsClick for full details — eligibility, all locations, contacts The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPD
NCT06474039 · COPD
RecruitingThis study aims to demonstrate the effects of triple therapy (ICS/LABA/LAMA) and dual bronchodilators (LAMA/LABA) on air trapping in the lungs' COPD patients and inflammatory mediators
PhasePhase 3
TypeInterventional
Age40 Years – 80 Years
WhereBangkoknoi, BKK, Thailand
SponsorMahidol University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Combined Effects of Transcutaneous Electrical Diaphragmatic Stimulation With ACBT'S in Copd
NCT07079553 · COPD
RecruitingThe combined effects of transcutaneous electrical diaphragmatic stimulation (TEDS) and active cycle of breathing techniques (ACBTs) in patients with chronic obstructive pulmonary disease (COPD) conducted as a randomized controlled trial at Gulab Devi Hospital, the study involved 50 participants aged 40 to 60 with mild to moderate COPD. Participants were divided into two groups, one receiving both TEDS and ACBT, and the other receiving only ACBT. Over 12 weeks, improvements in lung function, oxygen saturation, exercise capacity, and quality of life were measured using spirometry, pulse oximetry, the 6-minute walk test, and the St. George's Respiratory Questionnaire. Both groups showed significant improvement, but the group receiving ACBT alone showed a slightly higher mean rank in some outcomes. The study concludes that while both interventions are beneficial, ACBT alone may offer more consistent improvements. It recommends including respiratory muscle assessments and combining interventions with education and exercise in future research.
PhaseNA
TypeInterventional
Age40 Years – 60 Years
WhereLahore, Punjab Province, Pakistan
SponsorRiphah International University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Microbiological Diversity in Exhaled Air in COPD and Free of COPD
NCT05437198 · Chronic Obstructive Pulmonary Disease
RecruitingCOPD and non-COPD patients will be included in the study after collection of their non-objection. The exhalation will be collected to study the microbiological diversity of human exhalations. a second collection for the year +1 will be made, at the same time (between October and March).
Phase—
TypeObservational
Age18 Years – 70 Years
WhereCréteil, France
SponsorCentre Hospitalier Intercommunal Creteil
▾Tap for detailsClick for full details — eligibility, all locations, contacts Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS)
NCT05958563 · Sleep Apnea, COPD Exacerbation, Overlap Syndrome
RecruitingChronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) are both frequent respiratory diseases with estimated prevalences between 8 and 15% of the adult population. Because of those high prevalences those two entities are often associated in same patients (1 to 4% of the general population). This association is then referred to as Overlap Syndrome (CO-OS). Data from observational studies suggest that this association may have an additive or even synergistic negative impact on patient's prognosis. Indeed, in a cohort of patients diagnosed as having a CO-OS, patients who did not receive specific treatment for OSA had a 76% increased risk of death compared to patients treated with continuous positive airway pressure (CPAP) and a 2-fold increased risk of acute COPD exacerbation. In another cohort of patients with both OSA and severe oxygen treated COPD, untreated patients for OSA had a 5-fold increased risk of death compared to patients treated with CPAP. There are strong signals from observational studies in support of a beneficial impact of CPAP therapy on respiratory outcomes in patients with CO-OS. However, those findings are not supported by any controlled study. It is difficult to directly transpose the observational data to current clinical practice in the context of the recent studies on the impact of CPAP on OSA prognosis. Indeed, data from similar observational OSA cohorts have reported a major impact of CPAP on the overall survival and cardiovascular outcomes in patients with OSA. Ten years later, this impact has not been confirmed by several randomized studies. To date, there is no consensus on a systematic screening and, if present, management of OSA in patients with COPD. The need for specific research on that field was emphasized in 2018 in an official American Thoracic Society Research Statement which recommends "randomized trials that compare clinical outcomes among patients with Overlap Syndrome whose OSA is treated to clinical outcomes among patients with Overlap Syndrome whose OSA is untreated".
PhaseNA
TypeInterventional
Age40 Years
WhereAngers, France + 14 more
SponsorUniversity Hospital, Angers
▾Tap for detailsClick for full details — eligibility, all locations, contacts Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF
NCT05934565 · Chronic Obstructive Pulmonary Disease, Chronic Heart Failure
RecruitingThe goal of this fully-remote randomized controlled trial is to test the efficacy of Mindful Steps in facilitating physical activity compared to usual standard of care among 136 patients with COPD and/or HF. The main question it aims to answer is can this intervention promote physical activity as measured by daily step counts in sedentary patients with COPD and/or HF. Participants will be randomized (1:1 ratio) to receive either the Mindful Steps intervention or usual care for 12 months, with both arms receiving a Walking for Health education booklet.
PhaseNA
TypeInterventional
Age40 Years
WhereBoston, Massachusetts, United States + 1 more
SponsorBeth Israel Deaconess Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Adherence to Inhaled Therapy - a Globally Overlooked Problem in Patients With Chronic Obstructive Pulmonary Disease and Bronchial Asthma
NCT07183657 · Chronic Obstructive Pulmonary Disease (COPD), Bronchial Asthma
RecruitingComprehensive assessment and interventions to promote adherence to inhaled therapy in patients with bronchial asthma and chronic obstructive pulmonary disease involving health care professionals caring for these patients in different settings and using the Five Steps Assessment tool and artificial intelligence methods and tools.
PhaseNA
TypeInterventional
Age18 Years
WhereHradec Králové, Czechia
SponsorCharles University, Czech Republic
▾Tap for detailsClick for full details — eligibility, all locations, contacts Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia
NCT07037836 · COPD (Chronic Obstructive Pulmonary Disease), Hypoxemia
RecruitingThe goal of this clinical trial is to evaluate whether inhaled Treprostinil (Tyvaso) can improve oxygen delivery and blood flow in the lungs in adults (age ≥40) with chronic obstructive pulmonary disease (COPD) and hypoxemia who have less severe reduction in lung blood volume (diffusing capacity of the lungs for carbon monoxide \[DLCO\] ≥45%). The main questions it aims to answer are: 1. Does inhaled Treprostinil increase pulmonary capillary blood volume in ventilated lung regions, as measured by hyperpolarized xenon-129 magnetic resonance imaging (HP129Xe MRI)? 2. Does inhaled Treprostinil improve oxygen delivery (measured as red blood cell \[RBC\] chemical shift) and maintain or only slightly change pulmonary vascular resistance (measured by RBC oscillation amplitude)? 3. Can pre-treatment MRI parameters (RBC transfer and RBC oscillation amplitude) predict who will respond to inhaled Treprostinil? Participants will: * Use the Tyvaso nebulizer (inhaled Treprostinil) 4 times daily for 4 weeks, starting at 3 breaths per session and increasing to a maximum of 6 breaths per session as tolerated. * Undergo HP129Xe MRI before and after treatment to assess regional lung function and oxygen exchange. * Complete pulmonary function tests (PFTs), 6-minute walk tests (6MWT), and echocardiograms at the beginning and end of the study. * Be monitored for adverse events, with a phone check-in midway through and after the treatment period.
PhasePhase 2
TypeInterventional
Age40 Years
WhereDurham, North Carolina, United States
SponsorBastiaan Driehuys
▾Tap for detailsClick for full details — eligibility, all locations, contacts Randomized Controlled Study of Programmed Weaning From NIV for AECOPD
NCT06014034 · Acute Exacerbation of COPD
RecruitingPurpose of research:to explore a reasonable programmed withdrawal process of noninvasive ventilation and thereby reduce the duration of noninvasive mechanical ventilation in patients with acute exacerbations of chronic obstructive pulmonary disease.
PhaseNA
TypeInterventional
Age40 Years
WhereBeijing, Beijing Municipality, China
SponsorPeking University Third Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Sleepiz One+ vs. Capnography and Electrocardiography
NCT06569940 · Sleep Apnea, Asthma, COPD
RecruitingRespiratory Rate (RR) and heart rate (HR) are vital signs crucial for assessing a patient's overall health, providing insights into various conditions and stressors. Effective management of chronic diseases relies on detecting pathological changes early, with RR being among the most sensitive predictors of patient deterioration. Therefore, vigilant monitoring of RR and HR is vital for improving patient outcomes. The primary aim of this study is to provide a thorough comparison of the performance of Sleepiz One+ algorithms and end-tidal carbon dioxide measurement (EtCO2) Capnography for measuring respiration rate and electrocardiography (ECG) for measuring heart rate, in healthy adults and patients suffering from chronic conditions (e.g., hypertension, Chronic Obstructive Pulmonary Disease (COPD), asthma, diabetes), at rest in a clinical setting when the data is acquired with the new hardware version. Additionally, the investigators will evaluate the performance of RR estimation against the thoracic effort belt and the HR against the pulse oximetry.
PhaseNA
TypeInterventional
Age18 Years
WhereZurich, Canton of Zurich, Switzerland
SponsorSleepiz AG
▾Tap for detailsClick for full details — eligibility, all locations, contacts Neutrophil to Lymphocyte Ratio in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
NCT07125352 · Chronic Obstructive Pulmonary Disease Exacerbation
RecruitingChronic obstructive pulmonary disease (COPD) stands as one of the leading causes of mortality worldwide. Acute exacerbations of COPD (AECOPD) lead to rapid respiratory function decline and worsened disease status. Despite recent studies, the ability of the neutrophil-to-lymphocyte ratio (NLR) to predict outcomes in patients with COPD remains controversial. It remains controversial whether NLR can predict clinical outcomes in hospitalized patients with AECOPD. Therefore, this study was conducted to investigate the predictive value of NLR for severity, adverse outcomes in hospitalized patients with AECOPD, and predicting treatment response in patients with AECOPD
Phase—
TypeObservational
Age18 Years
WhereCairo, Abbasyea, Egypt
SponsorAin Shams University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Monitoring of the End-tidal Carbon Dioxide (EtCO2) as a Severity Criterion in COPD Exacerbations
NCT05704881 · Pulmonary Disease, Chronic Obstructive, Exacerbation Copd
RecruitingAlthough we know that these numbers are underestimated, Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease that affects between 8 and 12% of adults. According to a 2020 WHO report, it is the third most common cause of mortality in developed countries. This disease is punctuated by exacerbations associated with an 8% mortality of hospitalized patients, increased to 24% when the patient is admitted to intensive care unit. Early detection and treatment of these exacerbations appears to be essential to improve patient survival. End-tidal carbon dioxide (EtCO2) is used to assess a patient's respiratory and hemodynamic status. Indeed, EtCO2 is a non-invasive measure that could allow the estimation of arterial carbon dioxide (PaCO2) without performing blood gases, an arterial blood sampling, classically at the radial artery. This study aimed to find an EtCO2 value which at the time of the initial management, would be predictive of a severe COPD exacerbation, as well as PaCO2.
Phase—
TypeObservational
Age18 Years
WhereGrenoble, Isère, France + 1 more
SponsorUniversity Hospital, Grenoble
▾Tap for detailsClick for full details — eligibility, all locations, contacts Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
NCT07051707 · COPD, Chronic Obstructive Pulmonary Disease
RecruitingThe dNerva Lung Denervation System is one-time treatment intended to improve breathing in Chronic Obstructive Pulmonary Disease (COPD) patients on standard medical care. The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System in the treatment of COPD.
PhaseNA
TypeInterventional
Age40 Years – 80 Years
WhereBirmingham, Alabama, United States + 5 more
SponsorNuvaira, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Cardiac Assessment and Takotsubo-stunning Among COPD-exacerbations In-Hospital
NCT06597331 · Chronic Obstructive Pulmonary Disease, Takotsubo Cardiomyopathy, Acute Heart Failure
RecruitingThe goal of this prospective observational study is to investigate to what extent acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) triggers Takotsubo-stunning, and how this affects the outcome for these patients. The main questions it aims to answer are: 1. What is cumulative incidence of Takotsubo-stunning in patients hospitalized for AE-COPD at Sahlgrenska University Hospital/S (Gothenburg, Sweden)? 2. Among patients hospitalized for AE-COPD at Sahlgrenska University Hospital/S, what is the risk of in-hospital clinical manifestations of acute heart failure in patients with Takotsubo-stunning compared to those without?
Phase—
TypeObservational
Age18 Years
WhereGothenburg, Region Västra Götaland, Sweden
SponsorSahlgrenska University Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts InvEstigating oeStrogen Signalling and the Effect upoN the exTracelluar Matrix In pAtients With Obstructive Lung Disease
NCT06713512 · Chronic Obstructive Lung Disease, Respiratory Ilness, Estrogen Deficiency
RecruitingThis study aims to understand the role of oestrogen in patients with asthma and Chronic Obstructive Pulmonary Disorder (COPD). Therefore, what is the effect of oestrogen in these participants compared to controls (those without disease). The study hypothesises that oestrogen loss in patients with asthma and COPD causes accelerated lung function decline and changes to lung structure. It will investigate if this is mediated by inflammation, immune host response or elastin and collagen changes. It is an observational prospective cohort study aiming to recruit healthy controls, and people with asthma or COPD), and/or the menopause.
Phase—
TypeObservational
Age18 Years – 99 Years
WhereLondon, United Kingdom
SponsorGuy's and St Thomas' NHS Foundation Trust
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD
NCT07016412 · Chronic Obstructive Pulmonary Disease
RecruitingThis study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult subjects with chronic obstructive pulmonary disease (COPD).
PhasePhase 2
TypeInterventional
Age40 Years – 80 Years
WhereDothan, Alabama, United States + 54 more
SponsorVerona Pharma plc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Pulmonary Overdistension Assessment With Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrom in Prone Position.
NCT07090460 · Acute Respiratory Distress Syndrome (ARDS)
RecruitingMechanical ventilation in COPD requires a good interaction Patient-Ventilator without asynchronies in order to reduce mortality. Dynamic hyperinflation with PEEPi is responsible for major asynchronies in COPD. It is supposed to be symmetrical between the 2 lungs with the same PEEPi. EIT can measure the distribution of tidal ventilation and interlung lung insufflation delay on the impedance time curve of each lung. Moreover, it is possible in intubated COPD patients to assess one lung PEEPi during low flow insufflation with pressure-EIT monitoring. This study aims to measure interlungs insufflation delay under mechanical ventilation in COPD patients
Phase—
TypeObservational
Age18 Years
WhereBayonne, Centre Hospitalier de La Côte Basque, France
SponsorCentre Hospitalier de la côte Basque
▾Tap for detailsClick for full details — eligibility, all locations, contacts Mathematical Analysis of Signals and Clinical Parameters Provided by Non-invasive Home Ventilation Devices
NCT07267104 · COPD (Chronic Obstructive Pulmonary Disease)
RecruitingThis study will look at people with COPD who use a home breathing machine called non-invasive ventilation (NIV). NIV machines collect information about your breathing, such as air flow, pressure, and mask leaks. Researchers want to use a computer program, called artificial intelligence (AI), to study this information. The goal is to find early signs that your breathing may be getting worse. People with COPD who already use NIV at home may join this study. The study does not change your treatment. It only uses the breathing data already recorded by your NIV machine. The computer program will look for patterns in the data. These patterns may help doctors: Notice early warning signs of a COPD flare-up Find problems with how you and the machine work together Improve the way NIV is monitored at home The main goal is to create a tool that helps patients and doctors manage home NIV more easily and more safely.
Phase—
TypeObservational
Age40 Years – 80 Years
WhereSabadell, Barcelona, Spain
SponsorCorporacion Parc Tauli
▾Tap for detailsClick for full details — eligibility, all locations, contacts Tissue Immune Landscape of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation (TIL-GVHD)
NCT06247150 · Chronic Graft Versus Host Disease
RecruitingGraft versus Host Disease (GVHD) is frequent after allogeneic stem cell transplantation (alloSCT). GVHD occurs following 2 patterns : acute GVHD (aGVHD) or chronic GVHD (cGVHD). The latter occurs in nearly 50% of patients and its pathogenesis remains poorly understood. Previous translational studies have delineated biological immune dysregulation involved in cGVHD and facilitated the development of new drug and therapeutic strategies. New aspects of T and B cells collaboration in the context of cGVHD using blood description of a key player called TFH, classicaly involved in germinal center reaction, were previously uncovered (Forcade et al, Blood 2016). Previous studies in the context of auto-immune inflammation (lupus nephritis) or organ transplant rejection, suggested that target tissue could contain accessory lymphoid structures (TLS). The description of such structures in cGVHD target tissue would give the opportunity to directly analyze immune key player involved the pathogenesis of cGVHD.
PhaseNA
TypeInterventional
Age18 Years
WherePessac, France
SponsorUniversity Hospital, Bordeaux
▾Tap for detailsClick for full details — eligibility, all locations, contacts